%0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e27109 %T A Digital Health Intervention (SweetGoals) for Young Adults With Type 1 Diabetes: Protocol for a Factorial Randomized Trial %A Stanger,Catherine %A Kowatsch,Tobias %A Xie,Haiyi %A Nahum-Shani,Inbal %A Lim-Liberty,Frances %A Anderson,Molly %A Santhanam,Prabhakaran %A Kaden,Sarah %A Rosenberg,Briana %+ Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, 46 Centerra Parkway, Lebanon, NH, , United States, 1 603 646 7023, Catherine.stanger@dartmouth.edu %K type 1 diabetes %K mhealth %K incentives %K health coaching %K young adults %D 2021 %7 23.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Many young adults with type 1 diabetes (T1D) struggle with the complex daily demands of adherence to their medical regimen and fail to achieve target range glycemic control. Few interventions, however, have been developed specifically for this age group. Objective: In this randomized trial, we will provide a mobile app (SweetGoals) to all participants as a “core” intervention. The app prompts participants to upload data from their diabetes devices weekly to a device-agnostic uploader (Glooko), automatically retrieves uploaded data, assesses daily and weekly self-management goals, and generates feedback messages about goal attainment. Further, the trial will test two unique intervention components: (1) incentives to promote consistent daily adherence to goals, and (2) web health coaching to teach effective problem solving focused on personalized barriers to self-management. We will use a novel digital direct-to-patient recruitment method and intervention delivery model that transcends the clinic. Methods: A 2x2 factorial randomized trial will be conducted with 300 young adults ages 19-25 with type 1 diabetes and (Hb)A1c ≥ 8.0%. All participants will receive the SweetGoals app that tracks and provides feedback about two adherence targets: (a) daily glucose monitoring; and (b) mealtime behaviors. Participants will be randomized to the factorial combination of incentives and health coaching. The intervention will last 6 months. The primary outcome will be reduction in A1c. Secondary outcomes include self-regulation mechanisms in longitudinal mediation models and engagement metrics as a predictor of outcomes. Participants will complete 6- and 12-month follow-up assessments. We hypothesize greater sustained A1c improvements in participants who receive coaching and who receive incentives compared to those who do not receive those components. Results: Data collection is expected to be complete by February 2025. Analyses of primary and secondary outcomes are expected by December 2025. Conclusions: Successful completion of these aims will support dissemination and effectiveness studies of this intervention that seeks to improve glycemic control in this high-risk and understudied population of young adults with T1D. Trial Registration: ClinicalTrials.gov NCT04646473; https://clinicaltrials.gov/ct2/show/NCT04646473 International Registered Report Identifier (IRRID): PRR1-10.2196/27109 %M 33620330 %R 10.2196/27109 %U https://www.researchprotocols.org/2021/2/e27109 %U https://doi.org/10.2196/27109 %U http://www.ncbi.nlm.nih.gov/pubmed/33620330 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e22572 %T A Theory-Based mHealth Intervention (Getting Off) for Methamphetamine-Using Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial %A Reback,Cathy J %A Fletcher,Jesse B %A Mata,Raymond P %+ Friends Research Institution, Inc, 6910 Santa Monica Blvd, Los Angeles, CA, 90038, United States, 1 323 463 1601, rmata@friendsresearch.org %K HIV %K AIDS %K methamphetamine %K mHealth %K mobile app %K ART %K mobile phone %D 2021 %7 22.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Methamphetamine (meth) use among men who have sex with men (MSM) is associated with increased HIV prevalence and transmission and substandard advancement along the HIV prevention and care continuum. Given the growth of mobile health (mHealth) technologies, it is no longer necessary to limit meth treatment options to physical, brick-and-mortar sites, and administration using generic, nontailored content. Objective: In a 2-arm randomized controlled trial (RCT; N=300), we aim to evaluate the use of an mHealth intervention (Getting Off) to assess the impact and noninferiority of a cross-platform app (developed from a manualized meth treatment intervention) to help MSM reduce meth use and HIV sexual risk behaviors and improve their advancement along the HIV prevention and care continuum (HIV testing, pre-exposure prophylaxis uptake and persistence, and antiretroviral therapy uptake and adherence). Methods: Participants will be randomized into 2 arms: arm A, with immediate access to the app (immediate delivery: n=150), or arm B, with delayed access to the app after a 30-day period (delayed delivery: n=150). Participants in both arms will use the same Getting Off app and will have 30 days to complete the 24 sessions. Participants will be assessed at the 1-, 2- (delayed delivery arm only), 3-, 6-, and 9-month timepoints to determine observed treatment effects and will be compared with a historical matched sample of participants (n=~600) who received the brick-and-mortar group-based Getting Off intervention. Results: Recruitment began in January 2019 for phase 1, the formative phase. In January and February 2019, 4 focus groups (N=36) were formed to provide input on the adaptation of the group-based manual intervention to a mobile app. Data collection for phase 2, the RCT, is expected to be completed in January 2023. The final results are anticipated in April 2023. Conclusions: By creating a culturally responsive mobile app, Getting Off aims to reduce meth use and improve sexual health outcomes among meth-using MSM. The Getting Off app could have significant public health impact by greatly expanding access to effective, affordable, private, culturally competent, and highly scalable meth treatment for MSM. Trial Registration: Clinicaltrials.gov NCT03884946; https://clinicaltrials.gov/ct2/show/NCT03884946 International Registered Report Identifier (IRRID): DERR1-10.2196/22572 %M 33616547 %R 10.2196/22572 %U https://www.researchprotocols.org/2021/2/e22572 %U https://doi.org/10.2196/22572 %U http://www.ncbi.nlm.nih.gov/pubmed/33616547 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e25175 %T A Web-Based eHealth Intervention to Improve the Quality of Life of Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial %A Gustafson Sr,David H %A Mares,Marie-Louise %A Johnston,Darcie C %A Mahoney,Jane E %A Brown,Randall T %A Landucci,Gina %A Pe-Romashko,Klaren %A Cody,Olivia J %A Gustafson Jr,David H %A Shah,Dhavan V %+ Center for Health Enhancement Systems Studies, University of Wisconsin–Madison, Mechanical Engineering, 4th Fl, 1513 University Avenue, Madison, WI, 53706, United States, 1 608 890 2615, dcjohnston@wisc.edu %K eHealth %K telemedicine %K aged %K geriatrics %K multiple chronic conditions %K depression %K social support %K quality of life %K primary care %K health expenditures %K mobile phone %D 2021 %7 19.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Multiple chronic conditions (MCCs) are common among older adults and expensive to manage. Two-thirds of Medicare beneficiaries have multiple conditions (eg, diabetes and osteoarthritis) and account for more than 90% of Medicare spending. Patients with MCCs also experience lower quality of life and worse medical and psychiatric outcomes than patients without MCCs. In primary care settings, where MCCs are generally treated, care often focuses on laboratory results and medication management, and not quality of life, due in part to time constraints. eHealth systems, which have been shown to improve multiple outcomes, may be able to fill the gap, supplementing primary care and improving these patients’ lives. Objective: This study aims to assess the effects of ElderTree (ET), an eHealth intervention for older adults with MCCs, on quality of life and related measures. Methods: In this unblinded study, 346 adults aged 65 years and older with at least 3 of 5 targeted high-risk chronic conditions (hypertension, hyperlipidemia, diabetes, osteoarthritis, and BMI ≥30 kg/m2) were recruited from primary care clinics and randomized in a ratio of 1:1 to one of 2 conditions: usual care (UC) plus laptop computer, internet service, and ET or a control consisting of UC plus laptop and internet but no ET. Patients with ET have access for 12 months and will be followed up for an additional 6 months, for a total of 18 months. The primary outcomes of this study are the differences between the 2 groups with regard to measures of quality of life, psychological well-being, and loneliness. The secondary outcomes are between-group differences in laboratory scores, falls, symptom distress, medication adherence, and crisis and long-term health care use. We will also examine the mediators and moderators of the effects of ET. At baseline and months 6, 12, and 18, patients complete written surveys comprising validated scales selected for good psychometric properties with similar populations; laboratory data are collected from eHealth records; health care use and chronic conditions are collected from health records and patient surveys; and ET use data are collected continuously in system logs. We will use general linear models and linear mixed models to evaluate primary and secondary outcomes over time, with treatment condition as a between-subjects factor. Separate analyses will be conducted for outcomes that are noncontinuous or not correlated with other outcomes. Results: Recruitment was conducted from January 2018 to December 2019, and 346 participants were recruited. The intervention period will end in June 2021. Conclusions: With self-management and motivational strategies, health tracking, educational tools, and peer community and support, ET may help improve outcomes for patients coping with ongoing, complex MCCs. In addition, it may relieve some stress on the primary care system, with potential cost implications. Trial Registration: ClinicalTrials.gov NCT03387735; https://www.clinicaltrials.gov/ct2/show/NCT03387735. International Registered Report Identifier (IRRID): DERR1-10.2196/25175 %M 33605887 %R 10.2196/25175 %U http://www.researchprotocols.org/2021/2/e25175/ %U https://doi.org/10.2196/25175 %U http://www.ncbi.nlm.nih.gov/pubmed/33605887 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e24106 %T A Multicomponent Intervention to Reduce Screen Time Among Children Aged 2-5 Years in Chandigarh, North India: Protocol for a Randomized Controlled Trial %A Kaur,Nimran %A Gupta,Madhu %A Malhi,Prahbhjot %A Grover,Sandeep %+ Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India, 91 7087008223, madhugupta21@gmail.com %K multimedia %K digital-media %K preschooler %K sedentary behaviors %K toddler %K sedentary %K screen %K children %K youth %D 2021 %7 11.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Excessive digital screen exposure (≥1 hour per day) is associated with limited growth and development in children. Objective: This study aims to develop and assess a multicomponent intervention program's effectiveness in reducing excessive screen time among children aged 2-5 years. Methods: A theory-based multicomponent intervention known as Program to Lower Unwanted Media Screens (PLUMS) at the household level has been developed. It is based on the social cognitive theory for children and self-determination theory for caregivers. After pretesting, a randomized control trial will be conducted to assess this intervention's effectiveness among healthy children aged 2-5 (±3 months) years and their primary caregivers who have at least one digital media gadget at home in zone three of Chandigarh (population of 2,730,035). A sample size of 428 children is estimated per arm. PLUMS includes disseminating specific information, education, communication in the form of videos and posters to the primary caregivers, and conducting motivational interviewing as and when needed. Children will be provided suggestions for playful activities as alternatives to digital media gadgets. The primary outcome is the mean change in the duration of screen time, and secondary outcomes are sleep duration and patterns, emotional-behavioral problems, and level of physical activity of the children. Per-protocol and intention-to-treat analyses will be conducted using SPSS for Macintosh, Version 25.0. Results: The intervention package will be disseminated once a week for 8 weeks to the participants via the caregivers' preferred means of communication. The endline assessment will be done immediately postintervention and after the 6 months of follow-up. The Institute's ethics committee, Postgraduate Institute of Medical Education and Research, Chandigarh, India, has approved this study (INT/IEC/2019/000711). The Indian Council of Medical Research, New Delhi (3/1/3/Next-100/JRF-2015/HRD), and PGIMER, Chandigarh (71/2-Edu-16/92, Dated 08/01/2018) funded this study. Conclusions: PLUMS might be effective in reducing excessive screen time among children aged 2-5 years in a North Indian Union Territory. Trial Registration: Clinical Trial Registry India CTRI/2017/09/009761; https://tinyurl.com/53q6dpjs International Registered Report Identifier (IRRID): DERR1-10.2196/24106 %M 33570499 %R 10.2196/24106 %U http://www.researchprotocols.org/2021/2/e24106/ %U https://doi.org/10.2196/24106 %U http://www.ncbi.nlm.nih.gov/pubmed/33570499 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e26750 %T Effectiveness of an Integrated Engagement Support System to Facilitate Patient Use of Digital Diabetes Prevention Programs: Protocol for a Randomized Controlled Trial %A Lawrence,Katharine %A Rodriguez,Danissa V %A Feldthouse,Dawn M %A Shelley,Donna %A Yu,Jonathan L %A Belli,Hayley M %A Gonzalez,Javier %A Tasneem,Sumaiya %A Fontaine,Jerlisa %A Groom,Lisa L %A Luu,Son %A Wu,Yinxiang %A McTigue,Kathleen M %A Rockette-Wagner,Bonny %A Mann,Devin M %+ Healthcare Innovation Bridging Research, Informatics, and Design Lab, Department of Population Health, NYU Langone Health, 227 E 30th St, New York, NY, 10016, United States, 1 646 929 7870, hibrid.lab@nyulangone.org %K mobile health %K mHealth %K eHealth %K diabetes prevention %K type 2 diabetes mellitus %K mobile phone %D 2021 %7 9.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Digital diabetes prevention programs (dDPPs) are effective behavior change tools to prevent disease progression in patients at risk for diabetes. At present, these programs are poorly integrated into existing health information technology infrastructure and clinical workflows, resulting in barriers to provider-level knowledge of, interaction with, and support of patients who use dDPPs. Tools that can facilitate patient-provider interaction around dDPPs may contribute to improved patient engagement and adherence to these programs and improved health outcomes. Objective: This study aims to use a rigorous, user-centered design (UCD) methodology to develop a theory-driven system that supports patient engagement with dDPPs and their primary care providers with their care. Methods: This study will be conducted in 3 phases. In phase 1, we will use systematic UCD, Agile software development, and qualitative research methods to identify key user (patients, providers, clinical staff, digital health technologists, and content experts) requirements, constraints, and prioritization of high-impact features to design, develop, and refine a viable intervention prototype for the engagement system. In phase 2, we will conduct a single-arm feasibility pilot of the engagement system among patients with prediabetes and their primary care providers. In phase 3, we will conduct a 2-arm randomized controlled trial using the engagement system. Primary outcomes will be weight, BMI, and A1c at 6 and 12 months. Secondary outcomes will be patient engagement (use and activity) in the dDPP. The mediator variables (self-efficacy, digital health literacy, and patient-provider relationship) will be measured. Results: The project was initiated in 2018 and funded in September 2019. Enrollment and data collection for phase 1 began in September 2019 under an Institutional Review Board quality improvement waiver granted in July 2019. As of December 2020, 27 patients have been enrolled and first results are expected to be submitted for publication in early 2021. The study received Institutional Review Board approval for phases 2 and 3 in December 2020, and phase 2 enrollment is expected to begin in early 2021. Conclusions: Our findings will provide guidance for the design and development of technology to integrate dDPP platforms into existing clinical workflows. This will facilitate patient engagement in digital behavior change interventions and provider engagement in patients’ use of dDPPs. Integrated clinical tools that can facilitate patient-provider interaction around dDPPs may contribute to improved patient adherence to these programs and improved health outcomes by addressing barriers faced by both patients and providers. Further evaluation with pilot testing and a clinical trial will assess the effectiveness and implementation of these tools. Trial Registration: ClinicalTrials.gov NCT04049500; https://clinicaltrials.gov/ct2/show/NCT04049500 International Registered Report Identifier (IRRID): DERR1-10.2196/26750 %M 33560240 %R 10.2196/26750 %U http://www.researchprotocols.org/2021/2/e26750/ %U https://doi.org/10.2196/26750 %U http://www.ncbi.nlm.nih.gov/pubmed/33560240 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e25443 %T mHealth-Supported Delivery of an Evidence-Based Family Home-Visiting Intervention in Sierra Leone: Protocol for a Pilot Randomized Controlled Trial %A Desrosiers,Alethea %A Schafer,Carolyn %A Esliker,Rebecca %A Jambai,Musu %A Betancourt,Theresa S %+ Boston College, School of Social Work, 140 Commonwealth Avenue, Chestnut Hill, MA, 01778, United States, 1 617 552 8398, alethea.desrosiers@bc.edu %K mHealth %K caregiver mental health %K family functioning %K early childhood development %K community health workers %D 2021 %7 2.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Past trauma and exposure to violence have been related to poor emotion regulation and household violence, which can have persistent mental health effects across generations. The Family Strengthening Intervention for Early Childhood Development (FSI-ECD/called Sugira Muryango in Rwanda) is an evidence-based behavioral home-visiting intervention to promote caregiver mental health, positive parenting practices, and early childhood development among families facing adversity. In Sierra Leone and other lower- and middle-income countries, mobile health (mHealth) technology has the potential to improve health care delivery and health outcomes. Objective: This study aims to (1) apply a user-centered design to develop and test mHealth tools to improve supervision and fidelity monitoring of community health workers (CHWs) delivering the FSI-ECD and (2) conduct a pilot randomized controlled trial of the FSI-ECD to assess feasibility, acceptability, and preliminary effects on caregiver mental health, emotion regulation, caregiving behaviors, and family violence in high-risk families with children aged 6-36 months in comparison with control families receiving standard care. Methods: We will recruit and enroll CHWs, supervisors, and families with a child aged 6-36 months from community health clinics in Sierra Leone. CHWs and supervisors will participate in 1 problem analysis focus group and 2 user interface/user experience cycles to provide feedback on mHealth tool prototypes. Families will be randomized to mHealth-supported FSI-ECD or standard maternal and child health services. We will collect quantitative data on caregiver mental health, emotion regulation, caregiving behaviors, and family functioning at baseline, postintervention, and 3-month follow up. We will use a mixed methods approach to explore feasibility and acceptability of mHealth tools and the FSI-ECD. Mixed effects linear modeling will assess FSI-ECD effects on caregiver outcomes. Cost-effectiveness analysis will estimate costs across FSI-ECD versus standard care. Results: Funding for this study was received from the National Institutes of Mental Health on August 17, 2020. Institutional Review Board approval was received on September 4, 2020. Data collection is projected to begin on December 15, 2020. Conclusions: This study will provide important data on the feasibility, acceptability, and preliminary efficacy of mHealth-supported delivery of an evidence-based family home-visiting intervention in a postconflict LMIC. Trial Registration: ClinicalTrials.gov NCT04481399; https://clinicaltrials.gov/ct2/show/NCT04481399. International Registered Report Identifier (IRRID): PRR1-10.2196/25443 %M 33528371 %R 10.2196/25443 %U https://www.researchprotocols.org/2021/2/e25443 %U https://doi.org/10.2196/25443 %U http://www.ncbi.nlm.nih.gov/pubmed/33528371 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e26192 %T Mobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other) %A Logie,Carmen %A Okumu,Moses %A Hakiza,Robert %A Kibuuka Musoke,Daniel %A Berry,Isha %A Mwima,Simon %A Kyambadde,Peter %A Kiera,Uwase Mimy %A Loutet,Miranda %A Neema,Stella %A Newby,Katie %A McNamee,Clara %A Baral,Stefan D %A Lester,Richard %A Musinguzi,Joshua %A Mbuagbaw,Lawrence %+ Factor-Inwentash Faculty of Social Work, University of Toronto, 246 Bloor Street West, Toronto, ON, , Canada, 1 (416) 978 6314, carmen.logie@utoronto.ca %K adolescents and youth %K implementation research %K HIV testing %K mobile health %K refugee %K Uganda %D 2021 %7 2.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: HIV is the leading cause of mortality among youth in sub-Saharan Africa. Uganda hosts over 1.43 million refugees, and more than 83,000 live in Kampala, largely in informal settlements. There is limited information about HIV testing uptake and preferences among urban refugee and displaced youth. HIV self-testing is a promising method for increasing testing uptake. Further, mobile health (mHealth) interventions have been effective in increasing HIV testing uptake and could be particularly useful among youth. Objective: This study aims to evaluate the feasibility and effectiveness of two HIV self-testing implementation strategies (HIV self-testing intervention alone and HIV self-testing combined with an mHealth intervention) in comparison with the HIV testing standard of care in terms of HIV testing outcomes among refugee/displaced youth aged 16 to 24 years in Kampala, Uganda. Methods: A three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomization will be performed with a 1:1:1 method. Approximately 450 adolescents (150 per cluster) will be enrolled and followed for 12 months. Data will be collected at the following three time points: baseline enrollment, 8 months after enrollment, and 12 months after enrollment. Primary outcomes (HIV testing frequency, HIV status knowledge, linkage to confirmatory testing, and linkage to HIV care) and secondary outcomes (depression, condom use efficacy, consistent condom use, sexual relationship power, HIV stigma, and adolescent sexual and reproductive health stigma) will be evaluated. Results: The study has been conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (June 14, 2019), Mildmay Uganda (November 11, 2019), and the Uganda National Council for Science and Technology (August 3, 2020). The Tushirikiane trial launched in February 2020, recruiting a total of 452 participants. Data collection was paused for 8 months due to COVID-19. Data collection for wave 2 resumed in November 2020, and as of December 10, 2020, a total of 295 participants have been followed-up. The third, and final, wave of data collection will be conducted between February and March 2021. Conclusions: This study will contribute to the knowledge of differentiated HIV testing implementation strategies for urban refugee and displaced youth living in informal settlements. We will share the findings in peer-reviewed manuscripts and conference presentations. Trial Registration: ClinicalTrials.gov NCT04504097; https://clinicaltrials.gov/ct2/show/NCT04504097. International Registered Report Identifier (IRRID): DERR1-10.2196/26192 %M 33528378 %R 10.2196/26192 %U https://www.researchprotocols.org/2021/2/e26192 %U https://doi.org/10.2196/26192 %U http://www.ncbi.nlm.nih.gov/pubmed/33528378 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e23690 %T A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial %A Gans,Kim M %A Dulin,Akilah %A Palomo,Vanessa %A Benitez,Tanya %A Dunsiger,Shira %A Dionne,Laura %A Champion,Gregory %A Edgar,Rachelle %A Marcus,Bess %+ Department of Human Development and Family Sciences, University of Connecticut, 348 Mansfield Road, U-1058, Storrs, CT, 06269-1058, United States, 1 8604863865, kim.gans@uconn.edu %K physical activity %K Latino %K Hispanic %K men %K eHealth %K expert system %K internet %K text messaging %K mobile phone %K social media %D 2021 %7 29.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Latino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men. Objective: To address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables. Methods: Latino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization. Results: This study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing. Conclusions: We developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message–based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial. Trial Registration: Clinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570 International Registered Report Identifier (IRRID): DERR1-10.2196/23690 %M 33512327 %R 10.2196/23690 %U http://www.researchprotocols.org/2021/1/e23690/ %U https://doi.org/10.2196/23690 %U http://www.ncbi.nlm.nih.gov/pubmed/33512327 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25424 %T Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial %A Lakshminarayan,Kamakshi %A Murray,Thomas A %A Westberg,Sarah M %A Connett,John %A Overton,Val %A Nyman,John A %A Culhane-Pera,Kathleen A %A Pergament,Shannon L %A Drawz,Paul %A Vollbrecht,Emily %A Xiong,Txia %A Everson-Rose,Susan A %+ Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, 1300 S 2nd Street, Suite 300, Minneapolis, MN, 55415, United States, 1 6126249492, laksh004@umn.edu %K hypertension %K mobile health technology %K health disparities %K randomized controlled trial %D 2021 %7 25.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Suboptimal treatment of hypertension remains a widespread problem, particularly among minorities and socioeconomically disadvantaged groups. We present a health system–based intervention with diverse patient populations using readily available smartphone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control. Objective: The mGlide randomized controlled trial is a National Institutes of Health–funded study, evaluating whether a mobile health (mHealth)-based intervention that is an active partnership between interprofessional health care teams and patients results in better hypertension control rates than a state-of-clinical care comparison. Methods: We are recruiting 450 participants including stroke survivors and primary care patients with elevated cardiovascular disease risk from diverse health systems. These systems include an acute stroke service (n=100), an academic medical center (n=150), and community medical centers including Federally Qualified Health Centers serving low-income and minority (Latino, Hmong, African American, Somali) patients (n=200). The primary aim tests the clinical effectiveness of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained hypertension control rates at 12 months; describe provider experiences of system usability and satisfaction; examine patient experiences, including medication adherence and medication use self-efficacy, self-rated health and quality of life, and adverse event rates; and complete a cost-effectiveness analysis. Results: To date, we have randomized 107 participants (54 intervention, 53 control). Conclusions: This study will provide evidence for whether a readily available mHealth care model is better than state-of-clinical care for bridging the guideline-to-practice gap in hypertension treatment in health systems serving diverse patient populations. Trial Registration: Clinicaltrials.gov NCT03612271; https://clinicaltrials.gov/ct2/show/NCT03612271 International Registered Report Identifier (IRRID): DERR1-10.2196/25424 %M 33492231 %R 10.2196/25424 %U http://www.researchprotocols.org/2021/1/e25424/ %U https://doi.org/10.2196/25424 %U http://www.ncbi.nlm.nih.gov/pubmed/33492231 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25746 %T A Live Video Mind-Body Treatment to Prevent Persistent Symptoms Following Mild Traumatic Brain Injury: Protocol for a Mixed Methods Study %A Greenberg,Jonathan %A Singh,Tanya %A Iverson,Grant L %A Silverberg,Noah D %A Macklin,Eric A %A Parker,Robert A %A Giacino,Joseph T %A Yeh,Gloria Y %A Vranceanu,Ana-Maria %+ Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, 1 Bowdoin Square Suite #100, Boston, MA, 02114, United States, 1 6176439402, jgreenberg5@mgh.harvard.edu %K mild traumatic brain injury %K anxiety %K mixed methods %K intervention development %D 2021 %7 14.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Every year, approximately 42 million people sustain a mild traumatic brain injury (mTBI, also known as concussion), with particularly high rates among college-aged individuals. A substantial proportion of these people (44%-64%) develop persistent symptoms that are challenging to treat, costly, and associated with significant disability. Anxiety has emerged as a risk factor for progression from acute to persistent mTBI symptoms. Objective: This study aims to develop, adapt, and establish the feasibility of the Toolkit for Optimal Recovery after Concussions (TOR-C), an innovative mind-body program aimed at preventing persistent symptoms among young adults with mTBI and comorbid anxiety. Here, we describe the proposed study design, methodology, measurement, and treatment manuals. Methods: In phase 1, we will conduct individual, live video qualitative interviews (up to n=20) with college-aged individuals with mTBI and comorbid anxiety to inform adaptation of the intervention and study procedures. In phase 2, an open pilot of the live video TOR-C (n=5) with exit interviews will be conducted to explore the initial feasibility, acceptability, and credibility of the program and to refine the study procedures. Phase 3 will involve conducting a feasibility randomized controlled trial (N=50) of the TOR-C versus a health education control (Health Enhancement for Concussions; HE-C), both delivered via live video, to establish feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection; feasibility, credibility, and acceptability of the live video TOR-C and HE-C (adherence, retention, fidelity, and satisfaction) following prespecified benchmarks; and a signal of improvement in outcomes. Results: Phase 1 of the study has been approved by the Massachusetts General Hospital Institutional Review Board. Study completion is anticipated by early 2025. Conclusions: We will develop and test the first mind-body intervention focused on prevention of persistent symptoms following mTBI in young adults with comorbid anxiety problems. This will allow us to establish feasibility markers in postconcussive symptoms, anxiety, disability, and fear avoidance to inform a future efficacy trial of the TOR-C versus HE-C. International Registered Report Identifier (IRRID): PRR1-10.2196/25746 %M 33443484 %R 10.2196/25746 %U https://www.researchprotocols.org/2021/1/e25746 %U https://doi.org/10.2196/25746 %U http://www.ncbi.nlm.nih.gov/pubmed/33443484 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e22186 %T Use and Effect of Web-Based Embodied Conversational Agents for Improving Eating Behavior and Decreasing Loneliness Among Community-Dwelling Older Adults: Protocol for a Randomized Controlled Trial %A Kramer,Lean L %A Mulder,Bob C %A van Velsen,Lex %A de Vet,Emely %+ Consumption and Healthy Lifestyles, Wageningen University & Research, PO Box 8130, Wageningen, 6700 EW, Netherlands, 31 317 483401, lean.kramer@wur.nl %K embodied conversational agent %K health behavior change %K loneliness %K eating behavior %K older adults %D 2021 %7 6.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: An unhealthy eating pattern and loneliness negatively influence quality of life in older age. Embodied conversational agents (ECAs) are a promising way to address these health behaviors in an engaging manner. Objective: We aim to (1) identify whether ECAs can persuade community-dwelling older adults to change their dietary behavior and whether ECA use can decrease loneliness, (2) test these pathways to effects, and (3) understand the use of an ECA. Methods: The web-based eHealth app PACO is a fully automated 8-week intervention in which 2 ECAs engage older adults in dialogue to motivate them to change their dietary behavior and decrease their loneliness. PACO was developed via a human-centered and stakeholder-inclusive design approach and incorporates Self-determination Theory and various behavior change techniques. For this study, an unblinded randomized controlled trial will be performed. There will be 2 cohorts, with 30 participants per cohort. Participants in the first cohort will immediately receive the PACO app for 8 weeks, while participants in the second cohort receive the PACO app after a waiting-list condition of 4 weeks. Participants will be recruited via social media, an online panel, flyers, and advertorials. To be eligible, participants must be at least 65 years of age, must not be in paid employment, and must live alone independently at home. Primary outcomes will be self-assessed via online questionnaires at intake, control, after 4 weeks, and after 8 weeks, and will include eating behavior and loneliness. In addition, the primary outcome—use—will be measured via data logs. Secondary outcomes will be measured at the same junctures, via either validated, self-assessed, online questionnaires or an optional interview. Results: As of July 2020, we have begun recruiting participants. Conclusions: By unraveling the mechanisms behind the use of a web-based intervention with ECAs, we hope to gain a fine-grained understanding of both the effectiveness and the use of ECAs in the health context. Trial Registration: ClinicalTrials.gov NCT04510883; https://clinicaltrials.gov/ct2/show/NCT04510883 International Registered Report Identifier (IRRID): PRR1-10.2196/22186 %M 33404513 %R 10.2196/22186 %U https://www.researchprotocols.org/2021/1/e22186 %U https://doi.org/10.2196/22186 %U http://www.ncbi.nlm.nih.gov/pubmed/33404513 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e19770 %T A Community-Developed, Web-Based Mobile App Intervention Addressing Social Work and Legal Needs of Black Sexual Minority Men Living With HIV: Protocol for a Randomized Comparison Trial %A Miyashita Ochoa,Ayako %A Paneda,Christian Corpuz %A Wu,Elizabeth SC %A Maxwell,Katherine Elizabeth %A Garth,Gerald %A Smith,Terry %A Holloway,Ian Walter %+ Department of Social Welfare, UCLA Luskin School of Public Affairs, 337 Charles E Young Dr E, Los Angeles, CA, 90095, United States, 1 310 825 7840, holloway@luskin.ucla.edu %K HIV %K AIDS %K mobile apps %K African Americans %K men’s health %K sexual minority %K treatment adherence %K mobile phones %D 2021 %7 6.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Black sexual minority men (BSMM) are disproportionately affected by HIV. Los Angeles County (LAC) carries a substantial burden of the HIV epidemic in California. Negative effects of both psychosocial and structural barriers highlight the timely need to increase HIV treatment among BSMM. Successful HIV interventions based on social media and mobile phone technology have been demonstrated. This protocol describes LINX LA, a study that tests LINX, a web-based mobile app that provides tailored social services, legal resources, and peer support for BSMM living with HIV (BSMM+) in LAC using a randomized comparison trial. Objective: During phase 1, the LINX LA study aims to engage in an iterative design process to develop the LINX App using qualitative data to inform and tailor the mobile app technology and its functionality. In phase 2 of LINX LA, we will test the efficacy of the LINX App compared with the LINX App Plus to improve HIV treatment outcomes (ie, antiretroviral therapy adherence, viral suppression) among BSMM+ in LAC by addressing social work and legal needs and developing a forum for peer support. Methods: In this study funded by the California HIV/AIDS Research Program, we will recruit and enroll BSMM+ participants (aged ≥18 years) in LAC (N=400) to participate in a 12-month study that includes access to the LINX App, which provides a forum for peer support and tailored content aimed at improving the use of social and legal resources. All participants will also receive survey-based interviews at 3 time points (at baseline and 6- and 12-month intervals) and weekly text message surveys that assess medication and treatment adherence. Treatment adherence and viral suppression will be extracted from medical record data. Half of the participants will also be randomly assigned to receive 3 individualized coaching sessions (at 1-, 3-, and 6-month intervals) and the ability to directly message their coach via the LINX App. Over the course of the study, LINX App participants will receive a minimum of US $130 in cash and LINX App Plus participants will receive a minimum of US $190. We hypothesize that participants enrolled in LINX App Plus will demonstrate greater improvement in HIV outcomes compared with LINX App participants. Results: The LINX study will test the efficacy of a web-based mobile app intervention for BSMM+ in LAC (N=400). The LINX App seeks to increase participants’ knowledge of HIV; to facilitate access to necessary social and legal services, including information and referrals; and to increase social support across participants by providing a mediated forum for engagement. Conclusions: The implementation of LINX LA aims to develop and test a culturally tailored approach to improve the HIV treatment outcomes of BSMM+. International Registered Report Identifier (IRRID): PRR1-10.2196/19770 %M 33404514 %R 10.2196/19770 %U https://www.researchprotocols.org/2021/1/e19770 %U https://doi.org/10.2196/19770 %U http://www.ncbi.nlm.nih.gov/pubmed/33404514 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e18029 %T Using a Mobile Health Intervention (DOT Selfie) With Transfer of Social Bundle Incentives to Increase Treatment Adherence in Tuberculosis Patients in Uganda: Protocol for a Randomized Controlled Trial %A Sekandi,Juliet Nabbuye %A Onuoha,Nicole Amara %A Buregyeya,Esther %A Zalwango,Sarah %A Kaggwa,Patrick Evans %A Nakkonde,Damalie %A Kakaire,Robert %A Atuyambe,Lynn %A Whalen,Christopher C %A Dobbin,Kevin K %+ Global Health Institute, College of Public Health, University of Georgia, 100 Foster Road, Athens, GA, 30606, United States, 1 706 542 5257, jsekandi@uga.edu %K tuberculosis %K mHealth %K digital health %K eHealth %K directly observed therapy %K video observed therapy %K DOT Selfie %K treatment adherence %K Africa %D 2021 %7 5.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The World Health Organization’s End TB Strategy envisions a world free of tuberculosis (TB)—free of deaths, disease, and suffering due to TB—by 2035. Nonadherence reduces cure rates, prolongs infectiousness, and contributes to the emergence of multidrug-resistant TB (MDR-TB). Moreover, MDR-TB is a growing, complex, and costly problem that presents a major obstacle to TB control. Directly observed therapy (DOT) for treatment adherence monitoring is the recommended standard; however, it is challenging to implement at scale because it is labor-intensive. Mobile health interventions can facilitate remote adherence monitoring and minimize the costs and inconveniences associated with standard DOT. Objective: The study aims to evaluate the effectiveness of using video directly observed therapy (VDOT) plus incentives to improve medication adherence in TB treatment versus usual-care DOT in an African context. Methods: The DOT Selfie study is an open-label, randomized controlled trial (RCT) with 2 parallel groups, in which 144 adult patients with TB aged 18-65 years will be randomly assigned to receive the usual-care DOT monitoring or VDOT as the intervention. The intervention will consist of a smartphone app, a weekly internet subscription, translated text message reminders, and incentives for those who adhere. The participant will use a smartphone to record and send time-stamped encrypted videos showing their daily medication ingestion. This video component will directly substitute the need for daily face-to-face meetings between the health provider and patients. We hypothesize that the VDOT intervention will be more effective because it allows patients to swallow their pills anywhere, anytime. Moreover, patients will receive mobile-phone–based “social bundle” incentives to motivate adherence to continued daily submission of videos to the health system. The health providers will log into a secured computer system to verify treatment adherence, document missed doses, investigate the reasons for missed doses, and follow prespecified protocol measures to re-establish medication adherence. The primary endpoint is the adherence level as measured by the fraction of expected doses observed over the treatment period. The main secondary outcome will be time-to-treatment completion in both groups. Results: This study was funded in 2019. Enrollment began in July and is expected to be completed by November 2020. Data collection and follow-up are expected to be completed by June 2021. Results from the analyses based on the primary endpoint are expected to be submitted for publication by December 2021. Conclusions: This random control trial will be among the first to evaluate the effectiveness of VDOT within an African setting. The results will provide robust scientific evidence on the implementation and adoption of mobile health (mHealth) tools, coupled with incentives to motivate TB medication adherence. If successful, VDOT will apply to other low-income settings and a range of chronic diseases with lifelong treatment, such as HIV/AIDs. Trial Registration: ClinicalTrials.gov NCT04134689; http://clinicaltrials.gov/ct2/show/NCT04134689 International Registered Report Identifier (IRRID): DERR1-10.2196/18029 %M 32990629 %R 10.2196/18029 %U https://www.researchprotocols.org/2021/1/e18029 %U https://doi.org/10.2196/18029 %U http://www.ncbi.nlm.nih.gov/pubmed/32990629 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25351 %T Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study %A Mace,Ryan A %A Doorley,James D %A Popok,Paula J %A Vranceanu,Ana-Maria %+ Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, 1 Bowdoin Sq, 1st floor, Suite 100, Boston, MA, 02114, United States, 1 617 724 4977, avranceanu@mgh.harvard.edu %K chronic pain %K cognitive decline %K physical activity %K mind-body therapies %K aged %K telemedicine %K mobile phone %D 2021 %7 4.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. Objective: We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. Methods: This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). Results: The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). Conclusions: Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183 International Registered Report Identifier (IRRID): DERR1-10.2196/25351 %M 33208301 %R 10.2196/25351 %U https://www.researchprotocols.org/2021/1/e25351 %U https://doi.org/10.2196/25351 %U http://www.ncbi.nlm.nih.gov/pubmed/33208301 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e24043 %T Increasing HIV Testing and Viral Suppression via Stigma Reduction in a Social Networking Mobile Health Intervention Among Black and Latinx Young Men and Transgender Women Who Have Sex With Men (HealthMpowerment): Protocol for a Randomized Controlled Trial %A Muessig,Kathryn Elizabeth %A Golinkoff,Jesse M %A Hightow-Weidman,Lisa B %A Rochelle,Aimee E %A Mulawa,Marta I %A Hirshfield,Sabina %A Rosengren,A Lina %A Aryal,Subhash %A Buckner,Nickie %A Wilson,M Skye %A Watson,Dovie L %A Houang,Steven %A Bauermeister,José Arturo %+ Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, Chapel Hill, NC, 27599, United States, 1 919 962 5059, kmuessig@med.unc.edu %K HIV %K mHealth %K smartphone %K men who have sex with men %K racism %K transgender %K Hispanic Americans %K mobile phone %K African American %D 2020 %7 16.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Stigma and discrimination related to sexuality, race, ethnicity, and HIV status negatively impact HIV testing, engagement in care, and consistent viral suppression (VS) among young Black and Latinx men who have sex with men and transgender women who have sex with men (YBLMT). Few interventions address the effects of intersectional stigma among youth living with HIV and those at risk for HIV within the same virtual space. Objective: Building on the success of the HealthMpowerment (HMP) mobile health (mHealth) intervention (HMP 1.0) and with the input of a youth advisory board, HMP 2.0 is an app-based intervention that promotes user-generated content and social support to reduce intersectional stigma and improve HIV-related outcomes among YBLMT. The primary objective of this study is to test whether participants randomized to HMP 2.0 report improvement in HIV prevention and care continuum outcomes compared with an information-only control arm. We will also explore whether participant engagement, as measured by paradata (data collected as users interact with an mHealth intervention, eg, time spent using the intervention), mediates stigma- and HIV care–related outcomes. Finally, we will assess whether changes in intersectional stigma and improvements in HIV care continuum outcomes vary across different types of social networks formed within the intervention study arms. Methods: We will enroll 1050 YBLMT aged 15 to 29 years affected by HIV across the United States. Using an HIV-status stratified, randomized trial design, participants will be randomly assigned to 1 of the 3 app-based conditions (information-only app-based control arm, a researcher-created network arm of HMP 2.0, or a peer-referred network arm of HMP 2.0). Behavioral assessments will occur at baseline, 3, 6, 9, and 12 months. For participants living with HIV, self-collected biomarkers (viral load) are scheduled for baseline, 6, and 12 months. For HIV-negative participants, up to 3 HIV self-testing kits will be available during the study period. Results: Research activities began in September 2018 and are ongoing. The University of Pennsylvania is the central institutional review board for this study (protocol #829805) with institutional reliance agreements with the University of North Carolina at Chapel Hill, Duke University, and SUNY Downstate Health Sciences University. Study recruitment began on July 20, 2020. A total of 205 participants have been enrolled as of November 20, 2020. Conclusions: Among a large sample of US-based YBLMT, this study will assess whether HMP 2.0, an app-based intervention designed to ameliorate stigma and its negative sequelae, can increase routine HIV testing among HIV-negative participants and consistent VS among participants living with HIV. If efficacious and brought to scale, this intervention has the potential to significantly impact the disproportionate burden of HIV among YBLMT in the United States. Trial Registration: ClinicalTrials.gov NCT03678181; https://clinicaltrials.gov/ct2/show/study/NCT03678181. International Registered Report Identifier (IRRID): DERR1-10.2196/24043 %M 33325838 %R 10.2196/24043 %U https://www.researchprotocols.org/2020/12/e24043 %U https://doi.org/10.2196/24043 %U http://www.ncbi.nlm.nih.gov/pubmed/33325838 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e21772 %T An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial %A Gültzow,Thomas %A Smit,Eline Suzanne %A Hudales,Raesita %A Knapen,Vera %A Rademakers,Jany %A Dirksen,Carmen D %A Hoving,Ciska %+ Department of Health Promotion, Care and Public Health Research Institute, Maastricht University, P O Box 616, Maastricht, 6200 MD, Netherlands, 31 433882402, thomas.gultzow@maastrichtuniversity.nl %K digital health %K decision making %K decision support technique %K decision aids %K smoking %K smoking cessation %K informed decision making %D 2020 %7 15.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Decision aids (DAs) may be used to facilitate an autonomous, informed decision to cease smoking and promote the uptake of evidence-based cessation assistance (ie, behavioral support, nicotine replacement therapy, or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness. Objective: We describe the development process of an online DA (called “VISOR”) that helps smokers to choose evidence-based cessation assistance. Additionally, we provide a description of the protocol of an ongoing randomized controlled trial in which the DA containing an explicit value clarification method (VCM) and tailored advice is compared with a DA without an explicit VCM and tailored advice. Methods: The development of “VISOR” was based on the International Patient Decision Aid Standards guidelines. Viewpoints of end users (collected through 20 interviews with smokers) and clinical and scientific experts (assessed using 2 Delphi studies with 24 scientists and 38 clinicians) were assessed regarding cessation tool decision making and preferred DA content. These findings, together with principles from the Self-Determination Theory, served as input for the development of the online DA. A first DA prototype was alpha-tested in September 2019 and beta-tested for usability in December 2019; feedback was incorporated and resulted in a final version. The final DA contains (1) an information section, (2) an optional knowledge quiz, (3) a brief smoking assessment, (4) intuitive decision, (5) intermediate advice, (6) an explicit VCM, (7) tailored advice, and (8) access information. A randomized controlled trial is currently being conducted to assess the DA’s (cost-)effectiveness compared to a DA that does not include the explicit VCM and the tailored advice; specifically, the DA’s effect on smoking abstinence, uptake of evidence-based cessation assistance, smoking abstinence mediated through uptake of evidence-based cessation assistance, and decisional conflict are investigated. Participants are randomly allocated to receive access to 1 of the 2 DAs and are asked to complete 5 questionnaires (including the baseline questionnaire) over a period of 12 months. To evaluate the effects of the DA on the outcome measures, logistic and linear regression analyses as well as mediation analyses will be carried out. An economic evaluation will be performed to assess the cost-effectiveness. Results: Data regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021. Conclusions: By making use of an iterative process that integrated different stakeholders’ perspectives (including end users), we were able to systematically design an evidence-based DA. The study will contribute to the current knowledge regarding smoking cessation DA application, the added value of explicit VCMs, and the effect of behavioral and informed decision-making outcomes. Trial Registration: Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 International Registered Report Identifier (IRRID): DERR1-10.2196/21772 %M 33320096 %R 10.2196/21772 %U http://www.researchprotocols.org/2020/12/e21772/ %U https://doi.org/10.2196/21772 %U http://www.ncbi.nlm.nih.gov/pubmed/33320096 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e24383 %T COVID-19 Misinformation Prophylaxis: Protocol for a Randomized Trial of a Brief Informational Intervention %A Agley,Jon %A Xiao,Yunyu %A Thompson,Esi E %A Golzarri-Arroyo,Lilian %+ Prevention Insights, Department of Applied Health Science, School of Public Health Bloomington, Indiana University Bloomington, 501 N Morton St, Suite 110, Bloomington, IN, 47404, United States, 1 812 855 3123, jagley@indiana.edu %K COVID-19 %K misinformation %K infodemic %K infodemiology %K trust %K trust in science %K protocol %K intervention %K health information %K prevention %K behavior %D 2020 %7 7.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: As the COVID-19 pandemic continues to affect life in the United States, the important role of nonpharmaceutical preventive behaviors (such as wearing a face mask) in reducing the risk of infection has become clear. During the pandemic, researchers have observed the rapid proliferation of misinformed or inconsistent narratives about COVID-19. There is growing evidence that such misinformed narratives are associated with various forms of undesirable behavior (eg, burning down cell towers). Furthermore, individuals’ adherence to recommended COVID-19 preventive guidelines has been inconsistent, and such mandates have engendered opposition and controversy. Recent research suggests the possibility that trust in science and scientists may be an important thread to weave throughout these seemingly disparate components of the modern public health landscape. Thus, this paper describes the protocol for a randomized trial of a brief, digital intervention designed to increase trust in science. Objective: The objective of this study is to examine whether exposure to a curated infographic can increase trust in science, reduce the believability of misinformed narratives, and increase the likelihood to engage in preventive behaviors. Methods: This is a randomized, placebo-controlled, superiority trial comprising 2 parallel groups. A sample of 1000 adults aged ≥18 years who are representative of the population of the United States by gender, race and ethnicity, and age will be randomly assigned (via a 1:1 allocation) to an intervention or a placebo-control arm. The intervention will be a digital infographic with content based on principles of trust in science, developed by a health communications expert. The intervention will then be both pretested and pilot-tested to determine its viability. Study outcomes will include trust in science, a COVID-19 narrative belief latent profile membership, and the likelihood to engage in preventive behaviors, which will be controlled by 8 theoretically selected covariates. Results: This study was funded in August 2020, approved by the Indiana University Institutional Review Board on September 15, 2020, and prospectively registered with ClinicalTrials.gov. Conclusions: COVID-19 misinformation prophylaxis is crucial. This proposed experiment investigates the impact of a brief yet actionable intervention that can be easily disseminated to increase individuals’ trust in science, with the intention of affecting misinformation believability and, consequently, preventive behavioral intentions. Trial Registration: ClinicalTrials.gov NCT04557241; https://clinicaltrials.gov/ct2/show/NCT04557241 International Registered Report Identifier (IRRID): PRR1-10.2196/24383 %M 33175694 %R 10.2196/24383 %U http://www.researchprotocols.org/2020/12/e24383/ %U https://doi.org/10.2196/24383 %U http://www.ncbi.nlm.nih.gov/pubmed/33175694 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e18977 %T A Patient-Centered Asthma Management Communication Intervention for Rural Latino Children: Protocol for a Waiting-List Randomized Controlled Trial %A Dawson,Robin M %A Heiney,Sue P %A Messias,DeAnne Hilfinger %A Ownby,Dennis %+ College of Nursing, University of South Carolina, 1601 Greene St., Suite 623, Columbia, SC, 29208, United States, 1 803 576 6021, robin.dawson@sc.edu %K asthma %K mHealth %K mobile app %K Latino %K pediatrics %K family-centered care %K school nursing %K rural health %K RCT %K mobile phone %D 2020 %7 1.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Rural Latino children with asthma suffer high rates of uncontrolled asthma symptoms, emergency department visits, and repeat hospitalizations. This vulnerable population must negotiate micro- and macrolevel challenges that impact asthma management, including language barriers, primary care access, parental time off from work, insurance coverage, distance from specialty sites, and documentation status. There are few proven interventions that address asthma management embedded within this unique context. Objective: Using a bio-ecological approach, we will determine the feasibility of a patient-centered collaborative program between rural Latino children with asthma and their families, school-based nursing programs, and primary care providers, facilitated by the use of a smartphone-based mobile app with a Spanish-language interface. We hypothesize that improving communication through a collaborative, patient-centered intervention will improve asthma management, empower the patient and family, decrease outcome disparities, and decrease direct and indirect costs. Methods: The specific aims of this study include the following: (1) Aim 1: produce and validate a Spanish translation of an existing asthma management app and evaluate its usability with Latino parents of children with asthma, (2) Aim 2: develop and evaluate a triadic, patient-centered asthma intervention preliminary protocol, facilitated by the bilingual mobile app validated in Aim 1, and (3) Aim 3: investigate the feasibility of the patient-centered asthma intervention from Aim 2 using a waiting-list randomized controlled trial (RCT) to investigate the effects of the intervention on school days missed and medication adherence. Results: Mobile app translation, initial usability testing, and app software refinement were completed in 2019. Analysis is in progress. Preliminary protocol testing is underway; we anticipate that the waiting-list RCT, using the refined protocol developed in Aim 2, will commence in fall 2020. Conclusions: Tailored, technology-based solutions have the potential to successfully address issues affecting asthma management, including communication barriers, accessibility issues, medication adherence, and suboptimal technological interventions. Trial Registration: ClinicalTrials.gov NCT04633018; https://www.clinicaltrials.gov/ct2/show/NCT04633018 International Registered Report Identifier (IRRID): DERR1-10.2196/18977 %M 33258784 %R 10.2196/18977 %U https://www.researchprotocols.org/2020/12/e18977 %U https://doi.org/10.2196/18977 %U http://www.ncbi.nlm.nih.gov/pubmed/33258784 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 11 %P e20430 %T Assessing the Effect of Training on the Cognition and Brain of Older Adults: Protocol for a Three-Arm Randomized Double-Blind Controlled Trial (ACTOP) %A Boujut,Arnaud %A Mellah,Samira %A Lussier,Maxime %A Maltezos,Samantha %A Verty,Lynn Valeyry %A Bherer,Louis %A Belleville,Sylvie %+ Research Center, Institut universitaire de Gériatrie de Montréal, 4565, Queen-Mary Rd, Montréal, QC, H3W 1W5, Canada, 1 514 340 3540 ext 4767, sylvie.belleville@umontreal.ca %K cognitive training %K working memory %K brain plasticity %K aging %K cognitive reserve %D 2020 %7 24.11.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: To prevent age-related cognitive impairment, many intervention programs offer exercises targeting different central cognitive processes. However, the effects of different process-based training programs are rarely compared within equivalent experimental designs. Objective: Using a randomized double-blind controlled trial, this project aims to examine and compare the impact of 2 process-based interventions, inhibition and updating, on the cognition and brain of older adults. Methods: A total of 90 healthy older adults were randomly assigned to 1 of 3 training conditions: (1) inhibition (Stroop-like exercises), (2) updating (N-back-type exercises), and (3) control active (quiz game exercise). Training was provided in 12 half-hour sessions over 4 weeks. First, the performance gain observed will be measured on the trained tasks. We will then determine the extent of transfer of gain on (1) untrained tasks that rely on the same cognitive process, (2) complex working memory (WM) measurements hypothesized to involve 1 of the 2 trained processes, and (3) virtual reality tasks that were designed to mimic real-life situations that require WM. We will assess whether training increases cortical volume given that the volume of the cortex is determined by cortical area and thickness in regions known to be involved in WM or changes task-related brain activation patterns measured with functional magnetic resonance imaging. Dose effects will be examined by measuring outcomes at different time points during training. We will also determine whether individual characteristics moderate the effect of training on cognitive and cerebral outcomes. Finally, we will evaluate whether training reduces the age-related deficit on transfer and brain outcomes, by comparing study participants to a group of 30 younger adults. Results: The project was funded in January 2017; enrollment began in October 2017 and data collection was completed in April 2019. Data analysis has begun in June 2020 and the first results should be published by the end of 2020 or early 2021. Conclusions: The results of this study will help understand the relative efficacy of 2 attentional control interventions on the cognition and the brain of older adults, as well as the moderating role of individual characteristics on training efficiency and transfer. Trial Registration: ClinicalTrials.gov NCT03532113; https://clinicaltrials.gov/ct2/show/NCT03532113 International Registered Report Identifier (IRRID): DERR1-10.2196/20430 %M 33231556 %R 10.2196/20430 %U http://www.researchprotocols.org/2020/11/e20430/ %U https://doi.org/10.2196/20430 %U http://www.ncbi.nlm.nih.gov/pubmed/33231556 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 11 %P e18929 %T The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial %A Smith,Kirsten Ailsa %A Bradbury,Katherine %A Essery,Rosie %A Pollet,Sebastien %A Mowbray,Fiona %A Slodkowska-Barabasz,Joanna %A Denison-Day,James %A Hayter,Victoria %A Kelly,Jo %A Somerville,Jane %A Zhang,Jin %A Grey,Elisabeth %A Western,Max %A Ferrey,Anne E %A Krusche,Adele %A Stuart,Beth %A Mutrie,Nanette %A Robinson,Sian %A Yao,Guiqing Lily %A Griffiths,Gareth %A Robinson,Louise %A Rossor,Martin %A Gallacher,John %A Griffin,Simon %A Kendrick,Tony %A Rathod,Shanaya %A Gudgin,Bernard %A Phillips,Rosemary %A Stokes,Tom %A Niven,John %A Little,Paul %A Yardley,Lucy %+ Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Psychology, Building 44, University of Southampton, Southampton, SO17 1BJ, United Kingdom, 44 2380 592622, kirsten.smith@soton.ac.uk %K telemedicine %K dementia %K internet-based intervention %K geriatrics %K feasibility studies %K randomized controlled trial %D 2020 %7 20.11.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. Objective: In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. Methods: In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). Results: Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. Conclusions: The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. Trial Registration: International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980 International Registered Report Identifier (IRRID): DERR1-10.2196/18929 %M 33216010 %R 10.2196/18929 %U https://www.researchprotocols.org/2020/11/e18929 %U https://doi.org/10.2196/18929 %U http://www.ncbi.nlm.nih.gov/pubmed/33216010 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 11 %P e21799 %T Postdischarge Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Trial %A LeLaurin,Jennifer H %A Lamba,Avi H %A Eliazar-Macke,Nathaniel D %A Schmitzberger,Magda K %A Freytes,I Magaly %A Dang,Stuti %A Vogel,W Bruce %A Levy,Charles E %A Klanchar,S Angelina %A Beyth,Rebecca J %A Shorr,Ronald I %A Uphold,Constance R %+ North Florida/South Georgia Veterans Health System, 1601 SW Archer Rd, Gainesville, FL, 32608, United States, 1 352 376 1611, jlelaurin@ufl.edu %K COVID-19 %K stroke %K caregivers %K depression %K burden %K randomized controlled trial %K web-based intervention %K problem-solving %D 2020 %7 11.11.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The majority of stroke survivors return to their homes and need assistance from family caregivers to perform activities of daily living. These increased demands coupled with the lack of preparedness for their new roles lead to a high risk for caregivers developing depressive symptoms and other negative outcomes. Follow-up home support and problem-solving interventions with caregivers are crucial for maintaining stroke survivors in their homes. Problem-solving interventions are effective but are underused in practice because they require large amounts of staff time to implement and are difficult for caregivers logistically. Objective: The aim of this study is to test a problem-solving intervention for stroke caregivers that can be delivered over the telephone during the patient’s transitional care period (time when the stroke survivor is discharged to home) followed by 8 asynchronous online sessions. Methods: The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 240 caregivers from eight Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a modified problem-solving intervention that uses telephone and web-based support and training with interactive modules, fact sheets, and tools on the previously developed and nationally available Resources and Education for Stroke Caregivers’ Understanding and Empowerment Caregiver website. In the usual care group, no changes are made in the information, discharge planning, or care the patients who have had a stroke normally receive, and caregivers have access to existing VA resources (eg, caregiver support line, self-help materials). The primary outcome is a change in caregiver depressive symptoms at 11 and 19 weeks after baseline data collection. Secondary outcomes include changes in stroke caregivers’ burden, knowledge, positive aspects of caregiving, self-efficacy, perceived stress, health-related quality of life, and satisfaction with care and changes in stroke survivors’ functional abilities and health care use. The team will also determine the budgetary impact, facilitators, barriers, and best practices for implementing the intervention. Throughout all phases of the study, we will collaborate with members of an advisory panel. Results: Study enrollment began in June 2015 and is ongoing. The first results are expected to be submitted for publication in 2021. Conclusions: This is the first known study to test a transitional care and messaging center intervention combined with technology to decrease caregiver depressive symptoms and to improve the recovery of stroke survivors. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post stroke. Trial Registration: ClinicalTrials.gov NCT01600131; https://www.clinicaltrials.gov/ct2/show/NCT01600131 International Registered Report Identifier (IRRID): DERR1-10.2196/21799 %M 33174856 %R 10.2196/21799 %U http://www.researchprotocols.org/2020/11/e21799/ %U https://doi.org/10.2196/21799 %U http://www.ncbi.nlm.nih.gov/pubmed/33174856 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 11 %P e18891 %T Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial %A Rockette-Wagner,Bonny %A Fischer,Gary S %A Kriska,Andrea M %A Conroy,Molly B %A Dunstan,David %A Roumpz,Caroline %A McTigue,Kathleen M %+ Department of Epidemiology, School of Public Health, University of Pittsburgh, 5135 Public Health, 130 Desoto Street, Pittsburgh, PA, 15261, United States, 1 412 624 0188, bjr26@pitt.edu %K physical activity %K online intervention %K clinical translational research %D 2020 %7 3.11.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Most adults are not achieving recommended levels of physical activity (150 minutes/week, moderate-to-vigorous intensity). Inadequate activity levels are associated with numerous poor health outcomes, and clinical recommendations endorse physical activity in the front-line treatment of obesity, diabetes, dyslipidemia, and hypertension. A framework for physical activity prescription and referral has been developed, but has not been widely implemented. This may be due, in part, to the lack of feasible and effective physical activity intervention programs designed to coordinate with clinical care delivery. Objective: This manuscript describes the protocol for a pilot randomized controlled trial (RCT) that tests the efficacy of a 13-week online intervention for increasing physical activity in adult primary care patients (aged 21-70 years) reporting inadequate activity levels. The feasibility of implementing specific components of a physical activity clinical referral program, including screening for low activity levels and reporting patient program success to referring physicians, will also be examined. Analyses will include participant perspectives on maintaining physical activity. Methods: This pilot study includes a 3-month wait-listed control RCT (1:1 ratio within age strata 21-54 and 55-70 years). After the RCT primary end point at 3 months, wait-listed participants are offered the full intervention and all participants are followed to 6 months after starting the intervention program. Primary RCT outcomes include differences across randomized groups in average step count, moderate-to-vigorous physical activity, and sedentary behavior (minutes/day) derived from accelerometers. Maintenance of physical activity changes will be examined for all participants at 6 months after the intervention start. Results: Recruitment took place between October 2018 and May 2019 (79 participants were randomized). Data collection was completed in February 2020. Primary data analyses are ongoing. Conclusions: The results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician. Trial Registration: ClinicalTrials.gov NCT03695016; https://clinicaltrials.gov/ct2/show/NCT03695016. International Registered Report Identifier (IRRID): DERR1-10.2196/18891 %M 33141103 %R 10.2196/18891 %U https://www.researchprotocols.org/2020/11/e18891 %U https://doi.org/10.2196/18891 %U http://www.ncbi.nlm.nih.gov/pubmed/33141103 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 11 %P e19510 %T Integrating a Mobile Health Device Into a Community Youth Mental Health Team to Manage Severe Mental Illness: Protocol for a Randomized Controlled Trial %A Byrne,Simon %A Kotze,Beth %A Ramos,Fabio %A Casties,Achim %A Starling,Jean %A Harris,Anthony %+ Western Sydney Local Health District Mental Health Service, Westmead Hospital, Hawkesbury Rd Westmead, Sydney, NSW, Australia, 61 0437253851, simonpatrickbyrne@gmail.com %K electrodermal activity %K anxiety %K psychosis %K mHealth device %K actigraphy %D 2020 %7 2.11.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Symptoms of mental illness are often triggered by stress, and individuals with mental illness are sensitive to these effects. The development of mobile health (mHealth) devices allows continuous recording of biometrics associated with activity, sleep, and arousal. Deviations in these measures could indicate a stressed state requiring early intervention. This paper describes a protocol for integrating an mHealth device into a community mental health team to enhance management of severe mental illness in young adults. Objective: The aim of this study is to examine (1) whether an mHealth device integrated into a community mental health team can improve outcomes for young adults with severe mental illness and (2) whether the device detects periods of mental health versus deterioration. Methods: This study examines whether physiological information from an mHealth device prevents mental deterioration when shared with the participant and clinical team versus with the participant alone. A randomized controlled trial (RCT) will allocate 126 young adults from community mental health services for 6 months to standard case management combined with an integrated mHealth device (ie, physiological information is viewed by both participant and case manager: unWIRED intervention) or an unintegrated mHealth device (ie, participant alone self-monitors: control). Participants will wear the Empatica Embrace2 device, which continuously records electrodermal activity and actigraphy (ie, rest and activity). The study also examines whether the Embrace2 can detect periods of mental health versus deterioration. A variety of measurements will be taken, including physiological data from the Embrace2; participant and case manager self-report regarding symptoms, functioning, and quality of life; chart reviews; and ecological momentary assessments of stress in real time. Changes in each participant’s Clinical Global Impression Scale scores will be assessed by blinded raters as the primary outcome. In addition, participants and case managers will provide qualitative data regarding their experience with the integrated mHealth device, which will be thematically analyzed. Results: The study has received ethical approval from the Western Sydney Local Health District Human Research Ethics Committee. It is due to start in October 2020 and conclude in October 2022. Conclusions: The RCT will provide insight as to whether an integrated mHealth device enables case managers and participants to pre-emptively manage early warning signs and prevent relapse. We anticipate that unWIRED will enhance early intervention by improving detection of stress and allowing case managers and patients to better engage and respond to symptoms. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000642987; https://www.anzctr.org.au/ACTRN12620000642987.aspx International Registered Report Identifier (IRRID): PRR1-10.2196/19510 %M 33136053 %R 10.2196/19510 %U https://www.researchprotocols.org/2020/11/e19510 %U https://doi.org/10.2196/19510 %U http://www.ncbi.nlm.nih.gov/pubmed/33136053 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e17878 %T Web-Based Training for Nurses on Shared Decision Making and Prenatal Screening for Down Syndrome: Protocol for a Randomized Controlled Trial %A Poulin Herron,Alex %A Agbadje,Titilayo Tatiana %A Cote,Melissa %A Djade,Codjo Djignefa %A Roch,Geneviève %A Rousseau,Francois %A Légaré,France %+ Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Pavillon Landry-Poulin, door A-1-2, room A-4574, 2525, chemin de la Canardière, Québec, QC, G1J 0A4, Canada, 1 418 663 5713, France.Legare@fmed.ulaval.ca %K shared decision making %K prenatal screening %K training %K nurses %K behavioral intention %K Down syndrome %K continuing professional development %D 2020 %7 29.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Pregnant women often find it difficult to choose from among the wide variety of available prenatal screening options. To help pregnant women and their partners make informed decisions based on their values, needs, and preferences, a decision aid and a web-based shared decision making (SDM) training program for health professionals have been developed. In Canada, nurses provide maternity care and thus can train as decision coaches for prenatal screening. However, there is a knowledge gap about the effectiveness of SDM interventions in maternity care in nursing practice. Objective: This study aims to assess the impact of an SDM training program on nurses’ intentions to use a decision aid for prenatal screening and on their knowledge and to assess their overall impressions of the training. Methods: This is a 2-arm parallel randomized trial. French-speaking nurses working with pregnant women in the province of Quebec were recruited online by a private survey firm. They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone. The experimental intervention consisted of a 3-hour web-based training hosted on the Université Laval platform with 4 modules: (1) SDM; (2) Down syndrome prenatal screening; (3) decision aids; and (4) communication between health care professionals and the patient. For the control group, the topic of SDM in Module 1 was replaced with “Context and history of prenatal screening,” and the topic of decision aids in Module 3 was replaced with “Consent in prenatal screening.” Participants completed a self-administered sociodemographic questionnaire with close-ended questions. We also assessed the participants' (1) intention to use a decision aid in prenatal screening clinical practice, (2) knowledge, (3) satisfaction with the training, (4) acceptability, and (5) perceived usefulness of the training. The randomization was done using a predetermined sequence and included 40 nurses. Participants and researchers were blinded. Intention to use a decision aid will be assessed by a t test. Bivariate and multivariate analysis will be performed to assess knowledge and overall impressions of the training. Results: This study was funded in 2017 and approved by Genome Canada. Data were collected from September 2019 to late January 2020. This paper was initially submitted before data analysis began. Results are expected to be published in winter 2020. Conclusions: Study results will inform us on the impact of an SDM training program on nurses’ intention to use and knowledge of decision aids for prenatal screening and their overall impressions of the training. Participant feedback will also inform an upgrade of the program, if needed. Trial Registration: ClinicalTrials.gov NCT04162288; https://clinicaltrials.gov/ct2/show/NCT04162288 International Registered Report Identifier (IRRID): DERR1-10.2196/17878 %M 33118955 %R 10.2196/17878 %U http://www.researchprotocols.org/2020/10/e17878/ %U https://doi.org/10.2196/17878 %U http://www.ncbi.nlm.nih.gov/pubmed/33118955 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e23655 %T A Mobile Health Intervention (LifeBuoy App) to Help Young People Manage Suicidal Thoughts: Protocol for a Mixed-Methods Randomized Controlled Trial %A Han,Jin %A McGillivray,Lauren %A Wong,Quincy JJ %A Werner-Seidler,Aliza %A Wong,Iana %A Calear,Alison %A Christensen,Helen %A Torok,Michelle %+ Black Dog Institute, University of New South Wales, Hospital Road, Sydney, 2031, Australia, 61 9382 4368, j.han@blackdog.org.au %K suicide prevention %K mental health %K eHealth %K mHealth %K mobile health %K digital health %K smartphone app %K dialectical behavior therapy %D 2020 %7 27.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Self-help smartphone apps offer a new opportunity to address youth suicide prevention by improving access to support and by providing potentially high fidelity and cost-effective treatment. However, there have been very few smartphone apps providing evidence-based support for suicide prevention in this population. To address this gap, we developed the LifeBuoy app, a self-help smartphone app informed by dialectical behavior therapy (DBT), to help young people manage suicidal thoughts in their daily life. Objective: This study describes the protocol for a randomized controlled trial to evaluate the efficacy of the LifeBuoy app for reducing suicidal thoughts and behaviors, depression, anxiety, and psychological distress, and improving general mental well-being in young adults aged 18 to 25 years. Methods: This is a randomized controlled trial recruiting 378 young adults aged between 18 and 25 years and comparing the LifeBuoy app with a matched attention control (a placebo app with the same display but no DBT components). The primary outcome is suicidal thoughts measured by the Suicidal Ideation Attributes Scale (SIDAS). The secondary outcomes are suicidal behavior, depression, anxiety, psychological distress, and general mental well-being. The changes in the levels of insomnia, rumination, suicide cognitions, distress tolerance, loneliness, and help seeking before and after using the app are evaluated in this study. The study also addresses risk factors and responses to the intervention. A series of items assessing COVID-19 experiences is included in the trial to capture the potential impact of the pandemic on this study. Assessments will occur on the following three occasions: baseline, postintervention, and follow-up at 3 months postintervention. A qualitative interview about user experience with the LifeBuoy app will take place within 4 weeks of the final assessment. Using linear mixed models, the primary analysis will compare the changes in suicidal thoughts in the intervention condition relative to the control condition. To minimize risks, participants will receive a call from the team clinical psychologist by clicking a help button in the app or responding to an automated email sent by the system when they are assessed with elevated suicide risks at the baseline, postintervention, and 3-month follow-up surveys. Results: The trial recruitment started in May 2020. Data collection is currently ongoing. Conclusions: This is the first trial examining the efficacy of a DBT-informed smartphone app delivered to community-living young adults reporting suicidal thoughts. This trial will extend knowledge about the efficacy and acceptability of app-based support for suicidal thoughts in young people. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001671156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378366. International Registered Report Identifier (IRRID): PRR1-10.2196/23655 %M 33107832 %R 10.2196/23655 %U http://www.researchprotocols.org/2020/10/e23655/ %U https://doi.org/10.2196/23655 %U http://www.ncbi.nlm.nih.gov/pubmed/33107832 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e20412 %T A Telemonitoring and Hybrid Virtual Coaching Solution “CAir” for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial %A Gross,Christoph %A Kohlbrenner,Dario %A Clarenbach,Christian F %A Ivankay,Adam %A Brunschwiler,Thomas %A Nordmann,Yves %A v Wangenheim,Florian %+ Department of Management, Technology, and Economics, ETH Zürich, Weinbergstrasse 56/58, Zürich, 8092, Switzerland, 41 78 677 66 94, grossch@ethz.ch %K protocol %K randomized controlled trial %K chronic obstructive pulmonary disease %K telemonitoring %K virtual coaching %K disease management %K chatbot %K conversational agents %D 2020 %7 22.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic obstructive pulmonary disease (COPD) is one of the most common disorders in the world. COPD is characterized by airflow obstruction, which is not fully reversible. Patients usually experience breathing-related symptoms with periods of acute worsening and a substantial decrease in the health-related quality-of-life. Active and comprehensive disease management can slow down the progressive course of the disease and improve patients’ disabilities. Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention. Objective: This study aims to develop a comprehensive telemonitoring and hybrid virtual coaching solution and to investigate its effects on the health-related quality of life of patients with COPD. Methods: A monocentric, assessor-blind, two-arm (intervention/control) randomized controlled trial will be performed. Participants randomized to the control group will receive usual care and a CAir Desk (custom-built home disease-monitoring device to telemonitor disease-relevant parameters) for 12 weeks, without feedback or scores of the telemonitoring efforts and virtual coaching. Participants randomized to the intervention group will receive a CAir Desk and a hybrid digital coaching intervention for 12 weeks. As a primary outcome, we will measure the delta in the health-related quality of life, which we will assess with the St. George Respiratory Questionnaire, from baseline to week 12 (the end of the intervention). Results: The development of the CAir Desk and virtual coach has been completed. Recruitment to the trial started in September 2020. We expect to start data collection by December 2020 and expect it to last for approximately 18 months, as we follow a multiwave approach. We expect to complete data collection by mid-2022 and plan the dissemination of the results subsequently. Conclusions: To our knowledge, this is the first study investigating a combination of telemonitoring and hybrid virtual coaching in patients with COPD. We will investigate the effectiveness, efficacy, and usability of the proposed intervention and provide evidence to further develop app-based and chatbot-based disease monitoring and interventions in COPD. Trial Registration: ClinicalTrials.gov identifier: NCT04373070; https://clinicaltrials.gov/ct2/show/NCT04373070 International Registered Report Identifier (IRRID): DERR1-10.2196/20412 %M 33090112 %R 10.2196/20412 %U http://www.researchprotocols.org/2020/10/e20412/ %U https://doi.org/10.2196/20412 %U http://www.ncbi.nlm.nih.gov/pubmed/33090112 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e20191 %T Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy %A Idalski Carcone,April %A Ellis,Deborah A %A Eggly,Susan %A MacDonell,Karen E %A Ghosh,Samiran %A Buggs-Saxton,Colleen %A Ondersma,Steven J %+ Department of Family Medicine and Public Health Sciences, School of Medicine, Wayne State University, 6135 Woodward, Integrated Biosciences Bldg, Detroit, MI, 48202, United States, 1 3135771057, acarcone@med.wayne.edu %K emerging adults %K type 1 diabetes %K self-determination theory %K motivational interviewing %D 2020 %7 20.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Poor diabetes self-management in emerging adulthood (age 18-25 years) is associated with poorer diabetes health and diabetes complications. Emerging adults’ focus on individuation and independence underlies their poor diabetes outcomes, offering a lever for behavior change. Self-determination theory (SDT) suggests that interventions leveraging emerging adults’ innate developmental need for autonomy may offer a route to improving diabetes outcomes by increasing feelings of responsibility for and control over diabetes self-management activities. Objective: This research project will use the multiphase optimization strategy to test the efficacy of three autonomy-supportive intervention components to elicit a clinically significant improvement in metabolic control, assessed by a 0.5% improvement in hemoglobin A1c (HbA1c), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA1c≥9.0%). Methods: A question prompt list (QPL) is a tool to empower patients to assume a more active role during medical visits by asking questions and stating concerns. The motivation enhancement system (MES) is a brief counseling intervention that uses motivational interviewing communication strategies to build intrinsic motivation and self-efficacy for self-management. Text message reminders to complete diabetes care tasks may increase self-efficacy for diabetes self-management. After refining these intervention components for emerging adults, we will conduct a component selection experiment using an eight-arm full factorial design: 2 (QPL yes or no)×2 (MES yes or no)×2 (Text yes or no). Participants will complete 3 study visits: baseline, treatment end at 2 months, and a follow-up at 6 months. The primary outcome is metabolic control, which will be measured via HbA1c. Secondary outcomes include diabetes management and diabetes clinic attendance. SDT constructs of intrinsic motivation, self-efficacy, and the quality of the patient-provider relationship (ie, relatedness) are hypothesized mediators. Depression symptoms and emerging adults’ gender are hypothesized moderators. We will use the mixed-effects linear model for the analysis of variance of a factorial design to analyze continuous longitudinal experimental data; the generalized linear model will be used with categorical outcomes (eg, treatment attendance). The experiment was powered to detect the main effects of the intervention on the primary outcome. Results: A total of 20 participants have enrolled and completed a qualitative interview after reviewing one or more intervention components. Analysis of interview data are underway, with a report of these results anticipated in the fall of 2020. The clinical trial will be launched in the fall 2020, with participants enrolled through May 2023 and data collection continuing through November 2023. Conclusions: At the end of this experiment, we will have empirical evidence to support a large-scale, multisite effectiveness trial of an intervention package that has been optimized for older adolescents and emerging adults with poorly controlled T1D. Trial Registration: ClinicalTrials.gov NCT04066959; https://clinicaltrials.gov/ct2/show/NCT04066959 International Registered Report Identifier (IRRID): DERR1-10.2196/20191 %M 33079068 %R 10.2196/20191 %U http://www.researchprotocols.org/2020/10/e20191/ %U https://doi.org/10.2196/20191 %U http://www.ncbi.nlm.nih.gov/pubmed/33079068 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e23716 %T Coping Skills Mobile App to Support the Emotional Well-Being of Young People During the COVID-19 Pandemic: Protocol for a Mixed Methods Study %A Serlachius,Anna %A Schache,Kiralee %A Boggiss,Anna %A Lim,David %A Wallace-Boyd,Kate %A Brenton-Peters,Jennifer %A Buttenshaw,Elise %A Chadd,Stephanie %A Cavadino,Alana %A Cao,Nicholas %A Morunga,Eva %A Thabrew,Hiran %+ Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand, 64 09 923 3073, a.serlachius@auckland.ac.nz %K COVID-19 %K pandemic %K mental health %K mobile applications %K apps %K mHealth %K coping skills %K wellbeing %K adolescent %K young adult %K coping %D 2020 %7 8.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The COVID-19 pandemic is likely to increase anxiety and distress in young people worldwide. It is important to prioritize mental health during crisis events to mitigate the negative and often long-term effects of the crises on young people, families, and society. Mental health and well-being apps represent a scalable approach for improving psychological outcomes in young people and have potential to improve the equity of service access. Objective: The Whitu: 7 Ways in 7 Days well-being app was recently developed by our group to address the urgent need for innovative approaches to reach young New Zealanders who are struggling to cope with the COVID-19 pandemic. The aim of this study is twofold: to evaluate the acceptability of the prototype app and to examine the effectiveness of the refined app at improving mental and emotional well-being and reducing depression, anxiety, and stress in young people in New Zealand. Methods: A two-phase mixed methods study will be undertaken to achieve these aims. During the first phase, 20 young people aged 16-30 years (including those of Māori and Pacific ethnicity) will participate in a qualitative study to help refine the prototype app. During the second phase, 90 young people aged 16-30 years will participate in a randomized waitlist-controlled trial (RCT) to evaluate the efficacy of the refined Whitu app at 4 weeks and 3 months after baseline. Outcomes will be evaluated using validated web-based questionnaires at baseline, 4 weeks, and 3 months. Results: The study received ethics approval in May 2020, and recruitment for the focus groups commenced in June 2020. Recruitment for the RCT is expected to commence in October 2020. Participants for both study phases will be recruited via social media and web-based communities. Data collection for the RCT is expected to be completed by January 2021, and analyses are expected to be completed by March 2021. Linear mixed modelling will be used to determine between-group differences in psychological outcomes. Conclusions: There is an urgent need to develop culturally appropriate, scalable mental health interventions to address the psychological consequences of the COVID-19 pandemic. In this study, we will develop and test an evidence-based well-being app that, if effective, can be made available to all young people in New Zealand and internationally. Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12620000516987); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379597. International Registered Report Identifier (IRRID): PRR1-10.2196/23716 %M 32991303 %R 10.2196/23716 %U https://www.researchprotocols.org/2020/10/e23716 %U https://doi.org/10.2196/23716 %U http://www.ncbi.nlm.nih.gov/pubmed/32991303 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e20326 %T Psychological Treatment of Low Sexual Desire in Women: Protocol for a Randomized, Waitlist-Controlled Trial of Internet-Based Cognitive Behavioral and Mindfulness-Based Treatments %A Meyers,Milena %A Margraf,Jürgen %A Velten,Julia %+ Clinical Psychology and Psychotherapy, Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr University Bochum, Massenbergstr. 9-13, Bochum, 44787, Germany, 49 234 32 22159, julia.velten@rub.de %K sexual desire %K sexual dysfunction %K women’s sexual health %K cognitive behavioral therapy %D 2020 %7 29.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Psychological therapies are effective treatments for hypoactive sexual desire dysfunction (HSDD; formerly hypoactive sexual desire disorder), a common sexual dysfunction among women. Access to evidence-based treatments, however, remains difficult. Internet-based interventions are effective for a variety of psychological disorders and may be a promising means to close the treatment gap for HSDD. Objective: This article describes the treatment protocol and study design of a randomized controlled trial, aiming to study the efficacy of cognitive behavioral and mindfulness-based interventions delivered via the internet for women with HSDD to a waitlist control group. Outcomes are sexual desire (primary) and sexual distress (secondary). Additional variables (eg, depression, mindfulness, rumination) will be assessed as potential moderators or mediators of treatment success. Methods: A cognitive behavioral and a mindfulness-based self-help intervention for HSDD will be provided online. Overall, 266 women with HSDD will be recruited and assigned either to one of the intervention groups, or to a waitlist control group (2:2:1). Outcome data will be assessed at baseline, at 12 weeks, and at 6 and 12 months after randomization. Intention-to-treat and completer analyses will be conducted. Results: We expect improvements in sexual desire and sexuality-related distress in both intervention groups compared to the waitlist control. Recruitment has begun in January 2019 and is expected to be completed in August 2021. Results will be published in 2022. Conclusions: This study aims to contribute to the improvement and dissemination of psychological treatments for women with HSDD and to clarify whether cognitive behavioral and/or mindfulness-based treatments for HSDD are feasible and effective when delivered via the internet. Trial Registration: ClinicalTrials.gov NCT03780751; https://clinicaltrials.gov/ct2/show/NCT03780751 International Registered Report Identifier (IRRID): DERR1-10.2196/20326 %M 32990248 %R 10.2196/20326 %U http://www.researchprotocols.org/2020/9/e20326/ %U https://doi.org/10.2196/20326 %U http://www.ncbi.nlm.nih.gov/pubmed/32990248 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e19496 %T Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial %A Meisel,Zachary F %A Goldberg,Erica B %A Dolan,Abby R %A Bansal,Esha %A Rhodes,Karin V %A Hess,Erik P %A Cannuscio,Carolyn C %A Schapira,Marilyn M %A Perrone,Jeanmarie %A Rodgers,Melissa A %A Zyla,Michael M %A Bell,Jeffrey J %A McCollum,Sharon %A Shofer,Frances S %+ Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Drive, Blockley Hall, Philadelphia, PA, 19104, United States, 1 225 586 0267, zfm@pennmedicine.upenn.edu %K prescription opioids %K opioid misuse %K acute pain: opioid risk %K probabilistic risk tool %K renal colic %K musculoskeletal back pain %K narratives %K randomized controlled trial %D 2020 %7 24.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative–enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. Objective: Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. Methods: This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative–enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. Results: A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. Conclusions: This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. Trial Registration: ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092 International Registered Report Identifier (IRRID): DERR1-10.2196/19496 %M 32969832 %R 10.2196/19496 %U http://www.researchprotocols.org/2020/9/e19496/ %U https://doi.org/10.2196/19496 %U http://www.ncbi.nlm.nih.gov/pubmed/32969832 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e19881 %T Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial %A Schuurmans,Angela A T %A Nijhof,Karin S %A Scholte,Ron %A Popma,Arne %A Otten,Roy %+ Behavioural Science Institute, Radboud University, Montessorilaan 3, Nijmegen, 6525 HR, Netherlands, 31 24 361 61 61, angela.anna.schuurmans@gmail.com %K Adolescents %K Autonomic nervous system %K Cortisol %K Meditation %K Neurofeedback %K Posttraumatic stress %K Randomized controlled trial %K Trauma %D 2020 %7 23.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents’ intrinsic motivation. The neurofeedback element reinforces relaxation abilities. Objective: This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. Methods: This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. Results: The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. Conclusions: Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. Trial Registration: Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689 International Registered Report Identifier (IRRID): DERR1-10.2196/19881 %M 32965226 %R 10.2196/19881 %U http://www.researchprotocols.org/2020/9/e19881/ %U https://doi.org/10.2196/19881 %U http://www.ncbi.nlm.nih.gov/pubmed/32965226 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e17086 %T Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials %A Kroska,Emily B %A Hoel,Sydney %A Victory,Amanda %A Murphy,Susan A %A McInnis,Melvin G %A Stowe,Zachary N %A Cochran,Amy %+ Department of Population Health Sciences, University of Wisconsin–Madison, Room 685, 610 Walnut Drive, Madison, WI, 53726, United States, 1 (608) 262 0772, cochran4@wisc.edu %K acceptance and commitment therapy %K clinical trial %K mobile apps %K bipolar disorder %K students %K mobile phone %D 2020 %7 23.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Given gaps in the treatment of mental health, brief adaptive interventions have become a public health imperative. Transdiagnostic interventions may be particularly appropriate given high rates of medical comorbidity and the broader reach of transdiagnostic therapies. One such approach utilized herein is acceptance and commitment therapy (ACT), which is focused on increasing engagement with values, awareness, and openness to internal experiences. ACT theory posits that experiential avoidance is at the center of human suffering, regardless of diagnosis, and, as such, seeks to reduce unworkable experiential avoidance. Objective: Our objective is to provide the rationale and protocol for examining the safety, feasibility, and effectiveness of optimizing an ACT-based intervention via a mobile app among two disparate samples, which differ in sociodemographic characteristics and symptom profiles. Methods: Twice each day, participants are prompted via a mobile app to complete assessments of mood and activity and are then randomly assigned to an ACT-based intervention or not. These interventions are questions regarding engagement with values, awareness, and openness to internal experiences. Participant responses are recorded. Analyses will examine completion of assessments, change in symptoms from baseline assessment, and proximal change in mood and activity. A primary outcome of interest is proximal change in activity (eg, form and function of behavior and energy consumed by avoidance and values-based behavior) following interventions as a function of time, symptoms, and behavior, where we hypothesize that participants will focus more energy on values-based behaviors. Analyses will be conducted using a weighted and centered least squares approach. Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50). Results: Recruitment began on September 10, 2019, for the bipolar sample and on October 5, 2019, for the college sample. Participation in the study began on October 18, 2019. Conclusions: This study examines an ACT-based intervention among two disparate samples. Should ACT demonstrate feasibility and preliminary effectiveness in each sample, a large randomized controlled trial applying ACT across diagnoses and demographics would be indicated. The public health implications of such an approach may be far-reaching. Trial Registration: ClinicalTrials.gov NCT04098497; https://clinicaltrials.gov/ct2/show/NCT04098497; ClinicalTrials.gov NCT04081662; https://clinicaltrials.gov/ct2/show/NCT04081662 International Registered Report Identifier (IRRID): DERR1-10.2196/17086 %M 32965227 %R 10.2196/17086 %U http://www.researchprotocols.org/2020/9/e17086/ %U https://doi.org/10.2196/17086 %U http://www.ncbi.nlm.nih.gov/pubmed/32965227 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e18106 %T Mobile-Enhanced Prevention Support Study for Men Who Have Sex With Men and Transgender Women Leaving Jail: Protocol for a Randomized Controlled Trial %A Edwards,Gabriel G %A Reback,Cathy J %A Cunningham,William E %A Hilliard,Charles L %A McWells,Charles %A Mukherjee,Sukrit %A Weiss,Robert E %A Harawa,Nina T %+ Department of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California, Los Angeles, 1100 Glendon Ave Suite 850, Los Angeles, CA, 90024, United States, 1 310 267 0609, gedwards@mednet.ucla.edu %K HIV %K MSM %K transgender women %K peer navigation %K jail %K substance use disorder %K eHealth %K PrEP %K sexually transmitted infections %K hepatitis C %K mobile phone %K smartphone %D 2020 %7 22.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Men who have sex with men (MSM) and transgender women, particularly those who have experienced criminal justice involvement, have particularly high HIV burdens, and a majority of those in jail have substance use disorders (SUDs). MSM and transgender women also experience elevated rates of incarceration. Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use. Further, the impact experienced by one’s social and sexual networks experienced at the time of detention and release have important health implications for MSM and transgender women. Objective: The purpose of this study is to test a new intervention—Mobile-Enhanced Prevention Support (MEPS)—that involves a GPS-based mobile app called GeoPassport (referred to as GeoPass in practice), incentives, and peer support for promoting HIV prevention, substance use treatment, and use of related services. Methods: A two-arm, unblinded, randomized controlled trial will seek to enroll 300 HIV-negative MSM and transgender women, aged 18-49 years, with SUDs, who are either in jail or have recently left jail. Participants will be enrolled by study staff and randomized to the MEPS intervention group or usual care group. The intervention group will receive customized wellness goals in addition to GeoPass, cash incentives, and the support of a trained peer mentor for 6 months. Data collection will consist of a baseline survey and three follow-up surveys at 3, 6, and 9 months postenrollment, either in person or by phone or videoconference when necessary. The primary outcomes include establishing a primary care provider; being prescribed and adhering to pre-exposure prophylaxis (PrEP) for HIV; screening for HIV, STIs, and hepatitis C virus; and engagement in recommended treatment for SUDs. Secondary outcomes include obtaining treatment for any identified infections and avoiding recidivism. Results: Enrollment began in November 2019 and study completion is expected in 2023. Conclusions: This study will advance our knowledge base on patient navigation and peer mentor interventions. Peer navigation services have been studied for the treatment of HIV, but less often in the context of HIV and STI prevention among sexual and gender minority populations at the time of re-entry into the community from jail. The MEPS study will examine the acceptability and feasibility of combining peer mentor services with a mobile app to facilitate service utilization and participant–peer mentor communication. MEPS will assess patterns of PrEP uptake and utilization in MSM and transgender women leaving jail. The study will provide heretofore unavailable data from persons leaving jail regarding HIV PrEP, STI screening, substance abuse treatment, and service utilization patterns and experiences, including geocoded data for those in the intervention arm. Trial Registration: ClinicalTrials.gov (NCT04036396); https://www.clinicaltrials.gov/ct2/show/NCT04036396 International Registered Report Identifier (IRRID): PRR1-10.2196/18106 %M 32959786 %R 10.2196/18106 %U http://www.researchprotocols.org/2020/9/e18106/ %U https://doi.org/10.2196/18106 %U http://www.ncbi.nlm.nih.gov/pubmed/32959786 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e19288 %T Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial %A Rozwadowski,Michelle %A Dittakavi,Manasa %A Mazzoli,Amanda %A Hassett,Afton L %A Braun,Thomas %A Barton,Debra L %A Carlozzi,Noelle %A Sen,Srijan %A Tewari,Muneesh %A Hanauer,David A %A Choi,Sung Won %+ Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States, 1 73461505707, sungchoi@med.umich.edu %K family caregivers %K mobile health app %K mHealth %K randomized controlled trial %K wearable wrist sensor %K hematopoietic stem cell transplantation %K HSCT %D 2020 %7 18.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted widespread attention. Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory. Objective: This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation. Methods: The Roadmap 2.0 intervention will consist of a mobile randomized trial comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life, as assessed by the PROMIS Global Health scale at day 120 post-transplant. Secondary outcomes will include other PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records. Results: We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app. Conclusions: This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes. Trial Registration: ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844 International Registered Report Identifier (IRRID): PRR1-10.2196/19288 %M 32945777 %R 10.2196/19288 %U https://www.researchprotocols.org/2020/9/e19288 %U https://doi.org/10.2196/19288 %U http://www.ncbi.nlm.nih.gov/pubmed/32945777 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e18640 %T A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial %A Whiteley,Laura %A Olsen,Elizabeth %A Mena,Leandro %A Haubrick,Kayla %A Craker,Lacey %A Hershkowitz,Dylan %A Brown,Larry K %+ Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, 700 Butler Drive, Providence, RI, , United States, 1 401 455 6430, laura_whiteley@brown.edu %K pre-exposure prophylaxis (PrEP) %K adherence %K mobile gaming intervention %K HIV prevention %K men who have sex with men (MSM) %D 2020 %7 14.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP’s safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence. Objective: The goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior. Methods: This study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60). Results: Institutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing. Conclusions: This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings. Trial Registration: ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr International Registered Report Identifier (IRRID): DERR1-10.2196/18640 %M 32924954 %R 10.2196/18640 %U http://www.researchprotocols.org/2020/9/e18640/ %U https://doi.org/10.2196/18640 %U http://www.ncbi.nlm.nih.gov/pubmed/32924954 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e18538 %T Assessing a WeChat-Based Integrative Family Intervention (WIFI) for Schizophrenia: Protocol for a Stepped-Wedge Cluster Randomized Trial %A Yu,Yu %A Li,Tongxin %A Xi,Shijun %A Li,Yilu %A Xiao,Xi %A Yang,Min %A Ge,Xiaoping %A Xiao,Shuiyuan %A Tebes,Jacob %+ Department of Social Medicine and Health Management, Xiangya School of Public Health, Central South University, Upper Mayuanling Road No. 238, Changsha, 410008, China, 86 0731 84805459, xiaosy@csu.edu.cn %K schizophrenia %K family intervention %K WeChat %K psychoeducation %K peer support %K professional support %K stepped wedge %D 2020 %7 25.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Schizophrenia is a persistent and debilitating mental illness, and its prognosis depends largely on supportive care and systematic treatment. In developing countries like China, families constitute the major caregiving force for schizophrenia and are faced with many challenges, such as lack of knowledge, skills, and resources. The approach to support family caregiving in an accessible, affordable, feasible, and cost-effective way remains unclear. The wide-spread use of WeChat provides a promising and cost-effective medium for support. Objective: We aim to present a protocol for assessing a WeChat-based integrative family intervention (WIFI) to support family caregiving for schizophrenia. Methods: We will develop a WIFI program that includes the following three core components: (1) psychoeducation (WeChat official account), (2) peer support (WeChat chat group), and (3) professional support (WeChat video chat). A rigorous stepped-wedge cluster randomized trial will be used to evaluate the implementation, effectiveness, and cost of the WIFI program. The WIFI program will be implemented in 12 communities affiliated with Changsha Psychiatric Hospital through the free medicine delivery process in the 686 Program. The 12 communities will be randomized to one of four fixed sequences every 2 months during an 8-month intervention period in four clusters of three communities each. Outcomes will be assessed for both family caregivers and people with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support, coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. People with schizophrenia will be assessed for their symptoms, functioning, quality of life, recovery, and rehospitalization. Cost data, such as intervention costs, health care utilization costs, and costs associated with lost productivity, will be collected. Moreover, we will collect process data, including fidelity and quality of program implementation, as well as user attitude data. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling with clusters as a random effect and time as a fixed effect. Cost-effectiveness analysis will be performed from the societal perspective using incremental cost-effectiveness ratios. Qualitative analysis will use the grounded theory approach and immersion-crystallization process. Results: The study was funded in August 2018 and approved by the institutional review board on January 15, 2019. Preliminary baseline data collection was conducted in May 2019 and completed in September 2019. The WIFI program is expected to start in September 2020. Conclusions: This is the first study to assess a WeChat-based mHealth intervention to support family caregiving for schizophrenia in China. The innovative study will contribute to the development of a more cost-effective and evidence-based family management model in the community for people with schizophrenia, and the approach could potentially be integrated into national policy and adapted for use in other populations. Trial Registration: ClinicalTrials.gov NCT04393896; https://clinicaltrials.gov/ct2/show/NCT04393896. International Registered Report Identifier (IRRID): PRR1-10.2196/18538 %M 32687478 %R 10.2196/18538 %U http://www.researchprotocols.org/2020/8/e18538/ %U https://doi.org/10.2196/18538 %U http://www.ncbi.nlm.nih.gov/pubmed/32687478 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e16737 %T Promoting Physical Activity With Self-Tracking and Mobile-Based Coaching for Cardiac Surgery Patients During the Discharge–Rehabilitation Gap: Protocol for a Randomized Controlled Trial %A Zhang,Chao %A Soliman-Hamad,Mohamed %A Robijns,Roxanne %A Verberkmoes,Niels %A Verstappen,Frank %A IJsselsteijn,Wijnand A %+ Catharina Ziekenhuis Eindhoven, Michelangelolaan 2, Eindhoven, 5623 EJ, Netherlands, 31 402399111, mohammed.soliman@catharinaziekenhuis.nl %K self-tracking %K mobile-based coaching %K cardiac rehabilitation %K randomized controlled trial %K mHealth %K eHealth %D 2020 %7 19.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Home-based cardiac rehabilitations (CRs) with digital technologies have been researched and implemented to replace, augment, and complement traditional center-based CR in recent years with considerable success. One problem that technology-enhanced home-based CR can potentially address is the gap between cardiac interventions and formal CR programs. In the Netherlands and some other countries (eg, Australia), patients after cardiac interventions stay at home for 3-4 weeks without much support from their physicians, and often engage in very little physical activity (PA). A home-based exercise program enabled by digital technologies may help patients to better prepare for the later center-based CR programs, potentially increasing the uptake rate of those programs. Objective: In a randomized controlled trial (RCT), we will evaluate the effectiveness of a home-based walking exercise program enhanced by self-tracking and mobile-based coaching (treatment condition), comparing it with a version of the same program without these technologies (control condition). The added value of the digital technologies is justified if patients in the treatment group walk more steps on average (primary outcome) and show better physical fitness in a bicycle ergometer test and higher self-efficacy toward PA (secondary outcomes). Methods: Based on a power analysis, we will recruit 100 cardiac patients and assign them evenly to the 2 parallel groups. Eligible patients are those who are scheduled in the postanesthesia care unit, know the Dutch language, have basic literacy of using smartphones, and are without medical conditions that may increase risks associated with PA. In a face-to-face meeting with a nurse practitioner, all patients are prescribed a 3-week exercise program at home (2 walking exercises per day with increasing duration), based on national and international guidelines and tailored to their physical conditions after cardiac intervention. Their physical activities (daily steps) will be measured by the Axivity AX3 accelerometer worn at hip position. Patients in the treatment group will also be supported by a Neo Health One self-tracking device and a mobile platform called Heart Angel, through which they are monitored and coached by their nurses. After the study, all patients will perform a bicycle ergometer test and return the devices within 1 week. In addition, 5 questionnaires will be sent to the patients by emails to assess their self-efficacy toward PA and other psychological states for exploratory analyses (at discharge, at the end of each monitoring week, and 1 week after the study). To minimize bias, the randomization procedure will be performed after introducing the exercise program, so the nurse practitioners are blind to the experimental conditions until that point. Results: The study protocol has been approved by the Medical Research Ethics Committees United on February 26, 2018 (NL 62142.100.17/R17.51). By the end of 2018, we completed a small pilot study with 8 patients and the results based on interviews and app usage data suggest that a larger clinical trial with the targeted population is feasible. We expect to complete the RCT by the end of 2021, and statistical analyses will follow. Conclusions: Results of the RCT will help us to test the hypothesized benefits of self-tracking and mobile-based coaching for cardiac patients in home-based exercise programs during the discharge–rehabilitation gap. If the results are positive, cost-effectiveness analysis will be performed based on the insights of the study to inform the translation of the technology-enhanced program to clinical practice. We also note limitations of the trial in the discussion. Trial Registration: Registered at Netherlands Trial Register NL8040; https://www.trialregister.nl/trial/8040 International Registered Report Identifier (IRRID): PRR1-10.2196/16737 %M 32812886 %R 10.2196/16737 %U http://www.researchprotocols.org/2020/8/e16737/ %U https://doi.org/10.2196/16737 %U http://www.ncbi.nlm.nih.gov/pubmed/32812886 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e16711 %T Tailored Medication Adherence Incentives Using mHealth for Children With High-Risk Asthma (TAICAM): Protocol for a Randomized Controlled Trial %A Henderson,Brittney R %A Flaherty,Carina M %A Floyd,G Chandler %A You,Jack %A Xiao,Rui %A Bryant-Stephens,Tyra C %A Miller,Victoria A %A Feudtner,Chris %A Kenyon,Chén Collin %+ Department of Pediatrics, Children’s Hospital of Philadelphia, 3401 Civic Center Blvd, Philadelphia, PA, 19104, United States, 1 215 590 1000, kenyonc@email.chop.edu %K asthma %K pediatrics %K minority %K child %K adolescent %K metered dose inhalers %K medication adherence %K text messaging %K financial incentives %K behavior change %K randomized controlled trial %K clinical protocols %D 2020 %7 17.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Poor adherence to inhaled corticosteroid medications for children with high-risk asthma is both well documented and poorly understood. It has a disproportionate prevalence and impact on children of minority demographics in urban settings. Financial incentives have been shown to be a compelling method to engage those in a high-risk asthma population, but whether adherence can be maintained by offering financial incentives and how these incentives can be used to sustain high adherence are unknown. Objective: The aim of this study is to determine the marginal effects of a financial incentive–based intervention on inhaled corticosteroid adherence, health care system use, and costs. Methods: Participants include children aged 5 to 12 years who have had either at least two hospitalizations or one hospitalization and one emergency department visit for asthma in the year prior to their enrollment (and their caregivers). Participants are given an electronic inhaler sensor in order to track their medication use over a period of 7 months. After a 1-month period of observation, participants are randomized to 1 of 3 arms for a 3-month period. Participants in arm 1 receive daily text message reminders, feedback, and gain–framed, nominal financial incentives; participants in arm 2 receive daily text message reminders and feedback only, and participants in arm 3 receive no reminders, feedback, or incentives. All participants are subsequently observed for an additional 3-month period with no reminders, feedback, or incentives to assess whether any sustained effects are apparent. Results: Study enrollment began in September 2019 with a target sample size of N=125 children. As of June 2020, 61 children have been enrolled. Data collection is estimated to be completed in June 2022, and analyses will be completed by June 2023. Conclusions: This study will provide data that will help to determine whether a financial incentive–based mobile health intervention for promoting inhaled corticosteroid use can be effective in patients with high-risk asthma over longer periods. Trial Registration: Clinicaltrial.gov NCT03907410; https://clinicaltrials.gov/ct2/show/NCT03907410 International Registered Report Identifier (IRRID): DERR1-10.2196/16711 %M 32459653 %R 10.2196/16711 %U https://www.researchprotocols.org/2020/8/e16711 %U https://doi.org/10.2196/16711 %U http://www.ncbi.nlm.nih.gov/pubmed/32459653 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e19053 %T Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial %A Locke,Sean R %A Falkenhain,Kaja %A Lowe,Dylan A %A Lee,Terry %A Singer,Joel %A Weiss,Ethan J %A Little,Jonathan P %+ University of British Columbia, , Kelowna, BC, , Canada, 1 250 807 9876, jonathan.little@ubc.ca %K diet %K low carbohydrate %K mHealth %K ketogenic diet %K weight loss %D 2020 %7 17.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obesity and being overweight are major contributing factors for many diseases. Calorie restricted diets often fail to result in sustained long-term weight loss. Very low–carbohydrate, high-fat ketogenic diets have been suggested to have superior metabolic and weight loss effects. Keyto is a low-cost, highly scalable mobile health (mHealth) app paired with a noninvasive biofeedback tool aimed at facilitating weight loss through a personalized healthy and predominantly plant- and fish-based ketogenic diet. Objective: This protocol describes a randomized trial comparing the efficacy of the Keyto mHealth app and device intervention to that of Weight Watchers’ WW app in individuals who are overweight or obese. The primary outcome is weight loss after 12 weeks. Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24, and 48 weeks. Methods: A total of 144 participants will be recruited and randomized to either the Keyto program or Weight Watchers program. Study participants will be guided through the study via video conference or phone calls and will undergo a fasting blood analysis performed by a third-party diagnostic lab at weeks 0 and 12 to assess metabolic and cardiovascular risk markers. All participants will be asked to weigh themselves daily on a study-provided Bluetooth-enabled scale. Participants randomized to the Keyto arm will also be asked to measure their breath acetone levels, a measure of ketosis, with the Keyto device 3 times per day. Results: Recruitment started in December 2019. Rolling recruitment is expected to be completed by July 2020. Data collection and analysis of the primary intervention phase is expected to be completed in October 2020. The 24- and 48-week follow-ups are expected to be completed in January 2021 and July 2021, respectively. Conclusions: This trial will provide high-quality evidence regarding the efficacy of the Keyto weight loss program in individuals who are overweight and obese in a free-living condition. This study also fills a gap by examining the impact of a ketogenic diet emphasizing plant- and fish-based fats on blood lipid profile and cardiovascular disease risk. Trial Registration: ClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707. International Registered Report Identifier (IRRID): DERR1-10.2196/19053 %M 32804087 %R 10.2196/19053 %U http://www.researchprotocols.org/2020/8/e19053/ %U https://doi.org/10.2196/19053 %U http://www.ncbi.nlm.nih.gov/pubmed/32804087 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e18068 %T Acceptability and Usability of the Mobile Digital Health App NoObesity for Families and Health Care Professionals: Protocol for a Feasibility Study %A Meinert,Edward %A Rahman,Em %A Potter,Alison %A Lawrence,Wendy %A Van Velthoven,Michelle %+ Digitally Enabled PrevenTative Health (DEPTH) Research Group, Department of Paediatrics, Univeristy of Oxford, John Radcliffe Hospital, Oxford, United Kingdom, 44 7824446808, e.meinert14@imperial.ac.uk %K mHealth %K mobile health %K digital health %K digital technology %K weight loss %K obesity %K overweight %K child health %K cell phone %K telecommunication %D 2020 %7 22.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Almost a quarter or more than a fifth of children in the United Kingdom are overweight or obese by the time they start school. The UK Department of Health and Social Care’s national policy for combating childhood obesity has critical outcomes centered on sugar and caloric consumption reduction. Health Education England has developed two digital apps for families with children up to 15 years and for their associated health care professionals to provide a digital learning resource and tool aimed at encouraging healthy lifestyles to prevent obesity. Objective: This feasibility study assesses the usability and acceptability of Health Education England’s NoObesity app for undertaking activities to improve families’ diet and physical activity. The purpose of the study is to evaluate the app’s influence on self-efficacy and goal setting and to determine what can be learnt to improve its design for future studies, if there is evidence of adoption and sustainability. Methods: The study population will include 20 to 40 families and their linked health care professionals. Considering issues related to digital access associated with socioeconomic status and the impact on information technology use, study recruitment will be regionally focused in a low socioeconomic status area. The study will last for 9 months (3-month intervention period and 6-month follow-up). The evaluations of feasibility, acceptability, and usability will be conducted using the following scales and theoretical frameworks: (1) system usability scale; (2) Reach Effectiveness Adoption Implementation Maintenance framework; (3) Bandura model of health promotion; and (4) Nonadoption, Abandonment, and Challenges to the Scale-up, Spread, and Suitability framework. App use will be captured and quantitatively analyzed for net use patterns (eg, number of screens viewed, number of logins, cumulative minutes using the app, number of plans made, and number of times goals met) and to triangulate qualitative feedback from study participants. Results: This study was funded in March 2019 by Health Education England and received University of Oxford Medical Sciences Interdivisional Research Ethics Committee approval on January 31, 2020 (R62092/RE001). At manuscript submission, study recruitment is pending, and expected results will be published in 2021. Conclusions: This study will provide evidence on the NoObesity app’s influence on self-efficacy and goal-setting and determine what can be learnt to improve its design for future studies, if there is evidence of adoption and sustainability. International Registered Report Identifier (IRRID): PRR1-10.2196/18068 %M 32706703 %R 10.2196/18068 %U http://www.researchprotocols.org/2020/7/e18068/ %U https://doi.org/10.2196/18068 %U http://www.ncbi.nlm.nih.gov/pubmed/32706703 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e17160 %T Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial %A Proctor,Joanna %A Naughton,Felix %A Sloan,Melanie %A Hopewell,Sarah %A Brimicombe,James %A Prevost,A Toby %A Wilson,Edward C F %A Coleman,Tim %A Sutton,Stephen %+ University of Cambridge, Cambridge, United Kingdom, 44 1223 330594, srs34@medschl.cam.ac.uk %K text messaging %K smoking cessation %K internet-based intervention %K adults %K smokers %K tobacco %K primary care %D 2020 %7 14.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. Objective: This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. Methods: The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)—the control—with usual care plus iQuit—the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. Results: The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. Conclusions: iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004. International Registered Report Identifier (IRRID): DERR1-10.2196/17160 %M 32673255 %R 10.2196/17160 %U https://www.researchprotocols.org/2020/7/e17160 %U https://doi.org/10.2196/17160 %U http://www.ncbi.nlm.nih.gov/pubmed/32673255 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e16319 %T Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization: Protocol for an Efficacy and Implementation Study %A Hankins,Jane S %A Shah,Nirmish %A DiMartino,Lisa %A Brambilla,Donald %A Fernandez,Maria E %A Gibson,Robert W %A Gordeuk,Victor R %A Lottenberg,Richard %A Kutlar,Abdullah %A Melvin,Cathy %A Simon,Jena %A Wun,Ted %A Treadwell,Marsha %A Calhoun,Cecelia %A Baumann,Ana %A Potter,Michael B %A Klesges,Lisa %A Bosworth,Hayden %A , %+ St. Jude Childrens Research Hospital, 262 Danny Thomas place, MS 800, Memphis, TN, 38105, United States, 1 9015954153, jane.hankins@stjude.org %K sickle cell anemia %K digital medicine %K adherence %K hydroxycarbamide %K RE-AIM %K implementation science %K health innovation %K mobile phone %D 2020 %7 14.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hydroxyurea prevents disease complications among patients with sickle cell disease (SCD). Although its efficacy has been endorsed by the National Health Lung and Blood Institute evidence-based guidelines, its adoption is low, both by patients with SCD and providers. Mobile health (mHealth) apps provide benefits in improving medication adherence and self-efficacy among patients with chronic diseases and have facilitated prescription among medical providers. However, mHealth has not been systematically tested as a tool to increase hydroxyurea adherence nor has the combination of mHealth been assessed at both patient and provider levels to increase hydroxyurea utilization. Objective: This study aims to increase hydroxyurea utilization through a combined two-level mHealth intervention for both patients with SCD and their providers with the goals of increasing adherence to hydroxyurea among patients and improve hydroxyurea prescribing behavior among providers. Methods: We will test the efficacy of 2 mHealth interventions to increase both patient and provider utilization and knowledge of hydroxyurea in 8 clinical sites of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). The patient mHealth intervention, InCharge Health, includes multiple components that address memory, motivation, and knowledge barriers to hydroxyurea use. The provider mHealth intervention, Hydroxyurea Toolbox (HU Toolbox), addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea. The primary hypothesis is that among adolescents and adults with SCD, adherence to hydroxyurea, as measured by the proportion of days covered (the ratio of the number of days the patient is covered by the medication to the number of days in the treatment period), will increase by at least 20% after 24 weeks of receiving the InCharge Health app, compared with their adherence at baseline. As secondary objectives, we will (1) examine the change in health-related quality of life, acute disease complications, perceived health literacy, and perceived self-efficacy in taking hydroxyurea among patients who use InCharge Health and (2) examine potential increases in the awareness of hydroxyurea benefits and risks, appropriate prescribing, and perceived self-efficacy to correctly administer hydroxyurea therapy among SCD providers between baseline and 9 months of using the HU Toolbox app. We will measure the reach, adoption, implementation, and maintenance of both the InCharge Health and the HU Toolbox apps using the reach, effectiveness, adoption, implementation, and maintenance framework and qualitatively evaluate the implementation of both mHealth interventions. Results: The study is currently enrolling study participants. Recruitment is anticipated to be completed by mid-2021. Conclusions: If this two-level intervention, that is, the combined use of InCharge Health and HU Toolbox apps, demonstrates efficacy in increasing adherence to hydroxyurea and prescribing behavior in patients with SCD and their providers, respectively, both apps will be offered to other institutions outside the SCDIC through a future large-scale implementation-effectiveness study. Trial Registration: ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167 International Registered Report Identifier (IRRID): DERR1-10.2196/16319 %M 32442144 %R 10.2196/16319 %U https://www.researchprotocols.org/2020/7/e16319 %U https://doi.org/10.2196/16319 %U http://www.ncbi.nlm.nih.gov/pubmed/32442144 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e15994 %T A Web-Based Decision Aid (myAID) to Enhance Quality of Life, Empowerment, Decision Making, and Disease Control for Patients With Ulcerative Colitis: Protocol for a Cluster Randomized Controlled Trial %A Kim,Andrew H %A Girgis,Afaf %A Karimi,Neda %A Sechi,Alexandra J %A Descallar,Joseph %A Andrews,Jane M %A Siegel,Corey A %A Connor,Susan J %+ Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, The University of New South Wales, Department of Gastroenterology, Liverpool Hospital, Sydney, , Australia, 61 2 8738 4085, Susan.Connor1@health.nsw.gov.au %K shared decision making %K decision aid %K ulcerative colitis %D 2020 %7 10.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice. Objective: This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management. Methods: The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only). Results: Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021. Conclusions: myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370 International Registered Report Identifier (IRRID): DERR1-10.2196/15994 %M 32673257 %R 10.2196/15994 %U https://www.researchprotocols.org/2020/7/e15994 %U https://doi.org/10.2196/15994 %U http://www.ncbi.nlm.nih.gov/pubmed/32673257 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e12823 %T Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis: Protocol for a Pilot Randomized Controlled Trial %A Toupin April,Karine %A Stinson,Jennifer %A Cavallo,Sabrina %A Proulx,Laurie %A Wells,George A %A Duffy,Ciarán M %A ElHindi,Tania %A Longmuir,Patricia E %A Brosseau,Lucie %+ Children’s Hospital of Eastern Ontario Research Institute, 401 Smyth Road, L1147, Ottawa, ON, Canada, 1 6137377600 ext 4146, ktoupin@cheo.on.ca %K juvenile idiopathic arthritis %K yoga %K aerobic exercise %K dance %K pain management %K pilot %D 2020 %7 6.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Juvenile idiopathic arthritis (JIA) is one of the most common types of arthritis among children. According to JIA guidelines for physical activity (PA), structured PA interventions led to improved health outcomes. However, many PA programs, such as yoga and aerobic dance, have not been studied in this population despite being popular among youth. Web-based PA programs could provide patients with accessible and affordable interventions. Objective: The primary aims of the proposed pilot randomized controlled trial (RCT) are to examine (1) the feasibility of conducting a full-scale RCT to evaluate the effectiveness of two popular types of PA: a yoga training program and an aerobic dance training program, in female adolescents (aged 13-18 years) with JIA compared with an electronic pamphlet control group; and (2) the acceptability of these interventions. Methods: A three-arm prospective randomized open-label study with a parallel group design will be used. A total of 25 female adolescents with JIA who have pain will be randomized in a ratio of 2:2:1 to one of the 3 groups: (1) online yoga training program (group A: n=10); (2) online aerobic dance training program (group B: n=10); and (3) electronic pamphlet control group (group C: n=5). Participants in groups A and B will complete 3 individual 1-hour sessions per week using online exercise videos, as well as a 1-hour virtual group session per week using a videoconferencing platform for 12 weeks. Participants from all groups will have access to an electronic educational pamphlet on PA for arthritis developed by the Arthritis Society. All participants will also take part in weekly online consultations with a research coordinator and discussions on Facebook with participants from their own group. Feasibility (ie, recruitment rate, self-reported adherence to the interventions, dropout rates, and percentage of missing data), acceptability, and usability of Facebook and the videoconferencing platform will be assessed at the end of the program. Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline and then weekly until the end of the 12-week program. Results: This pilot RCT has been funded by the Arthritis Health Professions Association. This protocol was approved by the Children’s Hospital of Eastern Ontario Research Ethics Board (#17/08X). As of May 11, 2020, recruitment and data collection have not started. Conclusions: To our knowledge, this is the first study to evaluate the effectiveness of yoga and aerobic dance as pain management interventions for female adolescents with JIA. The use of online programs to disseminate these 2 PA interventions may facilitate access to alternative methods of pain management. This study can lead to a full-scale RCT. International Registered Report Identifier (IRRID): PRR1-10.2196/12823 %M 32442139 %R 10.2196/12823 %U https://www.researchprotocols.org/2020/7/e12823 %U https://doi.org/10.2196/12823 %U http://www.ncbi.nlm.nih.gov/pubmed/32442139 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e17561 %T A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial %A Ho,Andy Hau Yan %A Dutta,Oindrila %A Tan-Ho,Geraldine %A Tan,Toh Hsiang Benny %A Low,Xinyi Casuarine %A Ganapathy,Sashikumar %A Car,Josip %A Ho,Ringo Moon-Ho %A Miao,Chun Yan %+ Psychology Program, School of Social Sciences, Nanyang Technological University, 48 Nanyang Avenue, SHHKB-04-03, Singapore, 639818, Singapore, 65 63168943, andyhyho@ntu.edu.sg %K narrative therapy %K psychotherapy %K pediatric palliative care %K end-of-life care %K randomized controlled trial %K cyber-counseling %K mobile phone %D 2020 %7 5.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses. NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of parental bereavement and supported by literature on anticipatory grief interventions for improving the holistic well-being of parent caregivers of seriously ill children. Objective: This study's aim was to provide an accessible platform, NeW-I—which is a strengths- and meaning-focused and therapist-facilitated mobile app and web-based counseling platform—that aims to enhance quality of life, spiritual well-being, hope, and perceived social support and reduce depressive symptoms, caregiver burden, and risk of complicated grief among parents of children with chronic life-threatening illnesses. Methods: The NeW-I therapist-facilitated web-based platform comprises a mobile app and a website (both of which have the same content and functionality). NeW-I has been implemented in Singapore as a pilot open-label randomized controlled trial comprising intervention and control groups. Both primary and secondary outcomes will be self-reported by participants through questionnaires. In collaboration with leading pediatric palliative care providers in Singapore, the trial aims to enroll 36 participants in each group (N=72), so that when allowing for 30% attrition at follow-up, the sample size will be adequate to detect a small effect size of 0.2 in the primary outcome measure, with 90% power and two-sided significance level of at least .05. The potential effectiveness of NeW-I and the accessibility and feasibility of implementing and delivering the intervention will be assessed. Results: Funding support and institutional review board approval for this study have been secured. Data collection started in January 2019 and is ongoing. Conclusions: NeW-I aspires to enhance holistic pediatric palliative care services through a structured web-based counseling platform that is sensitive to the unique cultural needs of Asian family caregivers who are uncomfortable with expressing emotion even during times of loss and separation. The findings of this pilot study will inform the development of a full-scale NeW-I protocol and further research to evaluate the efficacy of NeW-I in Singapore and in other Asian communities around the world. Trial Registration: ClinicalTrials.gov NCT03684382; https://clinicaltrials.gov/ct2/show/NCT03684382 International Registered Report Identifier (IRRID): DERR1-10.2196/17561 %M 32623367 %R 10.2196/17561 %U https://www.researchprotocols.org/2020/7/e17561 %U https://doi.org/10.2196/17561 %U http://www.ncbi.nlm.nih.gov/pubmed/32623367 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 6 %P e18419 %T Determining the Impact of a School-Based Health Education Package for Prevention of Intestinal Worm Infections in the Philippines: Protocol for a Cluster Randomized Intervention Trial %A Mationg,Mary Lorraine S %A Williams,Gail M %A Tallo,Veronica L %A Olveda,Remigio M %A Aung,Eindra %A Alday,Portia %A Reñosa,Mark Donald %A Daga,Chona Mae %A Landicho,Jhoys %A Demonteverde,Maria Paz %A Santos,Eunice Dianne %A Bravo,Thea Andrea %A Angly Bieri,Franziska A %A Li,Yuesheng %A Clements,Archie C A %A Steinmann,Peter %A Halton,Kate %A Stewart,Donald E %A McManus,Donald P %A Gray,Darren J %+ Molecular Parasitology Laboratory, Infectious Diseases Division, QIMR Berghofer Medical Research Institute, 300 Herston Rd Herston Queensland, Brisbane, 4006, Australia, 61 7 3362 0401, Don.McManus@qimrberghofer.edu.au %K soil-transmitted helminths %K school-based health educational intervention %K Magic Glasses %K integrated control %K randomized controlled trial %K Philippines %D 2020 %7 25.6.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Repeated mass drug administration (MDA) of antihelminthics to at-risk populations is still the main strategy for the control of soil-transmitted helminth (STH) infections. However, MDA, as a stand-alone intervention, does not prevent reinfection. Accordingly, complementary measures to prevent STH reinfection, such as health education and improved sanitation, as part of an integrated control approach, are required to augment the effectiveness of MDA for optimal efficiency and sustainability. Objective: The aim of this study is to determine the impact and generalizability of a school-based health education package entitled The Magic Glasses for STH prevention in the Philippines. Methods: We conducted a cluster randomized controlled intervention trial, involving 2020 schoolchildren aged 9-10 years, in 40 schools in Laguna Province, Philippines, to evaluate the impact of the school-based health education package for the prevention of STHs. The trial was conducted over the course of 1 year (June 2016 to July 2017). A total of 20 schools were randomly assigned to the intervention arm, in which The Magic Glasses Philippines health education package was delivered with the standard health education activities endorsed by the Philippines Department of Health (DOH) and the Department of Education (DepEd). The other 20 schools comprised the control arm of the study, where the DOH/DepEd’s standard health education activities were done. At baseline, parasitological assessments and a knowledge, attitude, and practice survey were carried out in all schools. In addition, height, weight, and hemoglobin levels were obtained from each child (after parental consent), and their school attendance and academic performance in English and mathematics were accessed from the school records. The baseline and 2 follow-up surveys were completed using the same study measurements and quality-control assessments. Results: Key results from this cluster randomized intervention trial will shed light on the impact that The Magic Glasses health education package will have against STH infections in schoolchildren in the province of Laguna, located on the Island of Luzon, in the Calabarzon Region of the Philippines. Conclusions: The results of the trial will be used to assess the generalizability of the impact of The Magic Glasses health education package in different epidemiological and cultural settings, providing evidence for translation of this health education package into public health policy and practice in the Asian region and beyond. Trial Registration: Australian New Zealand Clinical Trials Registry number ACTRN12616000508471; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368849 International Registered Report Identifier (IRRID): DERR1-10.2196/18419 %M 32584263 %R 10.2196/18419 %U https://www.researchprotocols.org/2020/6/e18419 %U https://doi.org/10.2196/18419 %U http://www.ncbi.nlm.nih.gov/pubmed/32584263 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 6 %P e16964 %T Remote Monitoring Telemedicine (REMOTE) Platform for Patients With Anxiety Symptoms and Alcohol Use Disorder: Protocol for a Case-Control Study %A Pastor,Núria %A Khalilian,Elizabeth %A Caballeria,Elsa %A Morrison,Danielle %A Sanchez Luque,Unai %A Matrai,Silvia %A Gual,Antoni %A López-Pelayo,Hugo %+ HumanITcare - FOLLOWHEALTH SL, C/ Pau Gargallo, 30 (entrance Pascual i Vila), StartUB Building, Barcelona, 08028, Spain, 34 628994983, nuria.pastor@humanitcare.com %K digital health %K digital biomarkers %K digital phenotype %K mental health %D 2020 %7 24.6.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Monitoring mental health outcomes has traditionally been based on heuristic decisions, often based on scarce, subjective evidence, making the clinical decisions made by professionals, as well as the monitoring of these diseases, subject to flaws. However, the digital phenotype, which refers to the analysis of data collected by measuring human behavior with mobile sensors and smart bracelets, is a promising tool for filling this gap in current clinical practice. Objective: The objectives of this study are to develop the digital phenotyping of patients with alcohol use disorder and anxiety symptoms using data collected from a mobile device (ie, smartphone) and a wearable sensor (ie, Fitbit) and to analyze usability and patient satisfaction with the data collection service provided by the app. Methods: We propose to conduct a study among a group of 60 participants split into two subgroups—experimental and control—of 30 participants each. The experimental group will be recruited by physicians from the Hospital Clínic de Barcelona, and the control group will be recruited on a volunteer basis through fliers and social media. All participants will go through pretraining to ensure technological capability and understanding of tasks, then each participant will download the HumanITcare app and will be given a wearable sensor (ie, Fitbit). Throughout the 4-month period, participants will be monitored on a range of factors, including sleep cycle, heart rate, movement patterns, and sociability. All data from the wearable sensors and the mobile devices will be saved and sent to the HumanITcare server. Participants will be asked to complete weekly questionnaires about anxiety, depression, and alcohol use disorder symptoms. Research assistants will ensure timely responses. The data from both sensors will then be compared to the questionnaire responses to determine how accurately the devices can predict the same symptoms. Results: The recruitment phase was completed in November 2019 and all the data were collected by the end of December 2019. Data are being processed; this process is expected to be completed by October 2020. Conclusions: This study was created and conducted as a pilot study with the Hospital Clínic de Barcelona, with the purpose of exploring the feasibility of our approach. The study is focused on patients diagnosed with anxiety and alcohol use disorder, but participants were also monitored for depressive symptoms throughout the trial, although these were not part of the initial inclusion criteria. A limitation to our study was the exclusive use of Android smartphones over iOS devices; this could result in a potential selection bias, due to the accessibility and affordability of Android phones as opposed to iOS-based phones. Another limitation might be that reviews of usability and satisfaction could be confounded by factors such as age and familiarity. An additional function that we might add in future studies is the ability for patients to manage their own data. International Registered Report Identifier (IRRID): DERR1-10.2196/16964 %M 32579124 %R 10.2196/16964 %U https://www.researchprotocols.org/2020/6/e16964 %U https://doi.org/10.2196/16964 %U http://www.ncbi.nlm.nih.gov/pubmed/32579124 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 6 %P e17656 %T A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial %A Duthely,Lunthita M %A Sanchez-Covarrubias,Alex P %A Mohamed,Adhar B %A Potter,JoNell E %+ Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, PO Box 016960 (D-53), Miami, FL, 33101, United States, 1 3052435800, lduthely@med.miami.edu %K telemedicine %K HIV %K acquired immunodeficiency syndrome %K women %K adherence %K clinical trial protocol %K barriers %K facilitators %K text messaging %K mHealth %K SMS/texting %D 2020 %7 19.6.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adherence to HIV care is complex, as barriers to care are multidimensional, particularly for ethnic minority women. Mobile health (mHealth) solutions are supportive in improving HIV health care outcomes. In the United States, however, mHealth interventions are not widely implemented in public HIV clinics and have not been customized for women. There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV. Objective: This study aims to describe a protocol investigating the feasibility of an mHealth intervention for treatment adherence among women living with HIV. This is a two-phase, mixed methods, pilot randomized controlled trial that begins with qualitative patient interviews to inform the system design. Participants will be block randomized by language (English, Spanish, and Haitian Creole) to 1 of 2 study arms. Methods: Women (age ≥18 years) who were followed up at the women’s HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed), will be enrolled. The experimental arm will receive the intervention, which includes health reminders and psychoeducational messaging, plus clinical standard of care reminders. The psychoeducational messaging will target patient-level barriers of HIV stigma and medical mistrust and resilience as a patient-level strength. The control arm will receive standard of care reminders only (ie, mailed appointments and automated telephone calls). All aspects of the study and intervention will be offered in the participants’ preferred language. The primary outcome is the feasibility and acceptability of the study. The secondary outcomes are changes in self-reported medication adherence, depression symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants’ medical records. Data will be assessed at baseline (T0) and 2 subsequent clinic visits—approximately 3 to 4 months from the baseline (time 1; T1) and 6 to 9 months from the baseline (time 2; T2). Qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by the study group (chi-square, odds ratios, and t tests). Exploratory analyses will be conducted for each outcome variable—T1 and T2 values will be compared with values at T0 by the study group. Results: As of March 2020, baseline quantitative data were collected on 54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers). The first 3 focus groups (1 in each of the 3 languages) were completed, with a total of 20 participants. The findings are currently being integrated into the beta version of the mHealth texting system. Conclusions: The findings of this novel HIV adherence intervention may shed light on the barriers and facilitators of HIV health care and the mechanisms of an mHealth intervention that is customized for ethnic minority women living with HIV. Trial Registration: ClinicalTrials.gov NCT03738410; https://clinicaltrials.gov/ct2/show/NCT03738410 International Registered Report Identifier (IRRID): DERR1-10.2196/17656 %M 32438338 %R 10.2196/17656 %U http://www.researchprotocols.org/2020/6/e17656/ %U https://doi.org/10.2196/17656 %U http://www.ncbi.nlm.nih.gov/pubmed/32438338 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 6 %P e15080 %T A Web-Based Intervention to Reduce Decision Conflict Regarding HIV Pre-Exposure Prophylaxis: Protocol for a Clinical Trial %A Nelson,LaRon E %A Ajiboye,Wale %A Djiadeu,Pascal %A Odhiambo,Apondi J %A Pedersen,Cheryl %A Ramos,S Raquel %A Lofters,Aisha %A Mbuagbaw,Lawrence %A Williams,Geoffrey %+ Yale School of Nursing, Yale University, 222 York St, New Haven, CT, 06477, United States, 1 203 785 5797, laron.nelson@yale.edu %K pre-exposure prophylaxis %K PrEP %K HIV %K blacks %K prevention %K smartphone %K mobile phone %D 2020 %7 15.6.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: HIV pre-exposure prophylaxis (PrEP) is recommended for populations at high ongoing risk for infection. There are noted racial disparities in the incidence of HIV and other sexually transmitted infections (STIs) for African, Caribbean, and Canadian Black (ACB, black) populations in Ontario, Canada. Although blacks represent only 4.7% of the Ontario population, they account for 30% of HIV prevalence and 25% of new infections in the province. The existing clinical public health practice toolkit has not been sufficient to optimize PrEP uptake, despite the overwhelming evidence of PrEP’s efficacy for reducing HIV transmission risk. Since its establishment as an effective HIV prevention tool, the major focus in behavioral research on PrEP has been on understanding and improving adherence. To date, there is no known formalized intervention in place designed to support ACB men and women at high risk of making high-quality decisions regarding the adoption of PrEP as an HIV prevention practice. Objective: We propose 2 aims to address these gaps in HIV prevention and implementation science. First, the Ottawa Decision Support Framework (ODSF) for use in the PrEP decisional needs of black patients was adapted. Second, the decision support intervention to estimate effect size compared with control conditions in reducing decision conflict and predicting adherence over 60 days was pilot tested. Methods: In aim 1, we propose a cross-sectional qualitative descriptive study using data collected from key informant interviews with eligible PrEP patients (n=30) and surveys with health professionals (n=20) involved in HIV PrEP management. Data obtained from aim 1 will be used to develop a decision support intervention based on the ODSF. In aim 2, the adopted decision support intervention using a block-randomized design to estimate effect size compared with control conditions in reducing decision conflict and predicting adherence over 60 days was pilot tested. Hypothesis testing will be de-emphasized in favor of generating effect size estimates. Results: A research award was funded on March 25, 2017 (Multimedia Appendix 1). Ethical approval was received on March 25, 2019 (with supplemental approval received on May 10, 2019). Data collection started on April 9, 2019. As of September 30, 2019, we enrolled 29 patients and 24 health care providers for aim 1. We are currently analysing the data collected for aim 1. Aim 2 is scheduled to start in May 2020. Conclusions: This study will provide evidence-based information on the decisional needs of black patients who are at risk of HIV and have been offered PrEP. The study will also test the effect of decision support intervention in reducing decision conflict, adoption of PrEP, and adherence to PrEP. International Registered Report Identifier (IRRID): PRR1-10.2196/15080 %M 32348250 %R 10.2196/15080 %U https://www.researchprotocols.org/2020/6/e15080 %U https://doi.org/10.2196/15080 %U http://www.ncbi.nlm.nih.gov/pubmed/32348250 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 6 %P e17756 %T A Mobile Game (Safe City) Designed to Promote Children’s Safety Knowledge and Behaviors: Protocol for a Randomized Controlled Trial %A Wong,Rosa S %A Tung,Keith TS %A Wong,Hiu Tung %A Ho,Frederick KW %A Wong,Hing Sang %A Fu,King-Wa %A Pong,Ting Chuen %A Chan,Ko Ling %A Chow,Chun Bong %A Ip,Patrick %+ Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Queen Mary Hospital, Pokfulam Road, Hong Kong, China (Hong Kong), 852 2255 4090, patricip@hku.hk %K serious game %K safety training %K mobile game %K mobile phone %K injury prevention %K randomized controlled trial %K game-based intervention %D 2020 %7 12.6.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children have high levels of curiosity and eagerness to explore. This makes them more vulnerable to danger and hazards, and they thus have a higher risk of injury. Safety education such as teaching safety rules and tips is vital to prevent children from injuries. Although game-based approaches have the potential to capture children’s attention and sustain their interest in learning, whether these new instructional approaches are more effective than traditional approaches in delivering safety messages to children remains uncertain. Objective: The aim of this study is to test the effectiveness of a game-based intervention in promoting safety knowledge and behaviors among Hong Kong school children in Grades 4-6. It will also examine the potential effect of the game-based intervention on these children’s functioning and psychosocial difficulties. Methods: This study comprises the development of a city-based role-playing game Safe City, where players are immersed as safety inspectors to prevent dangerous situations and promote safety behavior in a virtual city environment. The usability and acceptability tests will be conducted with children in Grades 4-6 who will trial the gameplay on a mobile phone. Adjustments will be made based on their feedback. A 4-week randomized controlled trial with children studying in Grades 4-6 in Hong Kong elementary schools will be conducted to assess the effectiveness of the Safe City game–based intervention. In this trial, 504 children will play Safe City, and 504 children will receive traditional instructional materials (electronic and printed safety information). The evaluation will be conducted using both child self-report and parent proxy-report data. Specifically, child safety knowledge and behaviors will be assessed by a questionnaire involving items on knowledge and behaviors, respectively, for home safety, road safety, and sport-related safety; child functioning will be assessed by PedsQL Generic Core Scales; and psychosocial difficulties will be assessed by the Strength and Difficulties Questionnaire. These questionnaires will be administered at 3 time points: before, 1 month, and 3 months after the intervention. Game usage statistics will also be reviewed. Results: This project was funded in September 2019. The design and development of the Safe City game are currently under way. Recruitment and data collection will begin from September 2020 and will continue up to March 1, 2021. Full analysis will be conducted after the end of the data collection period. Conclusions: If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public. Trial Registration: ClinicalTrials.gov NCT04096196; https://clinicaltrials.gov/ct2/show/NCT04096196 International Registered Report Identifier (IRRID): PRR1-10.2196/17756 %M 32530436 %R 10.2196/17756 %U http://www.researchprotocols.org/2020/6/e17756/ %U https://doi.org/10.2196/17756 %U http://www.ncbi.nlm.nih.gov/pubmed/32530436 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 6 %P e18098 %T A Clinical Trial to Increase Self-Monitoring of Physical Activity and Eating Behaviors Among Adolescents: Protocol for the ImPACT Feasibility Study %A Moore,Justin B %A Dilley,Joshua R %A Singletary,Camelia R %A Skelton,Joseph A %A Miller Jr,David P %A Heboyan,Vahé %A De Leo,Gianluca %A Turner-McGrievy,Gabrielle %A McGrievy,Matthew %A Ip,Edward H %+ Department of Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, 525 Vine St, Winston-Salem, NC, 27101, United States, 1 336 716 3702, jusmoore@wakehealth.edu %K physical activity %K obesity %K adolescence %K adult %K therapy, family %K mobile phone %D 2020 %7 5.6.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Severe obesity among youths (BMI for age≥120th percentile) has been steadily increasing. The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight loss interventions, which highlights that a family-based treatment approach is warranted. This strategy has been successful in our existing evidence-based pediatric weight management program, Brenner Families in Training (Brenner FIT). However, this program relies on face-to-face encounters, which are limited by the time constraints of the families enrolled in treatment. Objective: This study aims to refine and test a tailored suite of mobile health (mHealth) components to augment an existing evidence-based pediatric weight management program. Methods: Study outcomes will include acceptability from a patient and clinical staff perspective, feasibility, and economic costs relative to the established weight management protocol alone (ie, Brenner FIT vs Brenner FIT + mHealth [Brenner mFIT]). The Brenner mFIT intervention will consist of 6 mHealth components designed to increase patient and caregiver exposure to Brenner FIT programmatic content including the following: (1) a mobile-enabled website, (2) dietary and physical activity tracking, (3) caregiver podcasts (n=12), (4) animated videos (n=6) for adolescent patients, (5) interactive messaging, and (6) in-person tailored clinical feedback provided based on a web-based dashboard. For the study, 80 youths with obesity (aged 13-18 years) and caregiver dyads will be randomized to Brenner FIT or Brenner mFIT. All participants will complete baseline measures before randomization and at 3- and 6-month follow-up points. Results: This study was approved by the Institutional Review Board in July 2019, funded in August 2019, and will commence enrollment in April 2020. The results of the study are expected to be published in the fall/winter of 2021. Conclusions: The results of this study will be used to inform a large-scale implementation-effectiveness clinical trial. International Registered Report Identifier (IRRID): PRR1-10.2196/18098 %M 32348291 %R 10.2196/18098 %U https://www.researchprotocols.org/2020/6/e18098 %U https://doi.org/10.2196/18098 %U http://www.ncbi.nlm.nih.gov/pubmed/32348291 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 5 %P e17078 %T A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial %A Salsman,John M %A McLouth,Laurie E %A Cohn,Michael %A Tooze,Janet A %A Sorkin,Mia %A Moskowitz,Judith T %+ Department of Social Sciences and Health Policy, Wake Forest Baptist Comprehensive Cancer Center, Wake Forest School of Medicine, Medical Center Boulevard, Winston Salem, NC, 27157, United States, 1 336 713 3613, jsalsman@wakehealth.edu %K emotions %K telemedicine %K happiness %K eHealth %K cancer %K young adult %K internet %K mobile phone %D 2020 %7 28.5.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adolescent and young adult cancer survivors (AYAs) experience clinically significant distress and have limited access to supportive care services. Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations but have not been routinely tested in AYAs. Objective: The aim of this protocol is to (1) test the feasibility and acceptability of a Web-based positive emotion skills intervention for posttreatment AYAs called Enhancing Management of Psychological Outcomes With Emotion Regulation (EMPOWER) and (2) examine proof of concept for reducing psychological distress and enhancing psychological well-being. Methods: The intervention development and testing are taking place in 3 phases. In phase 1, we adapted the content of an existing, Web-based positive emotion intervention so that it would be suitable for AYAs. EMPOWER targets 8 skills (noticing positive events, capitalizing, gratitude, mindfulness, positive reappraisal, goal setting, personal strengths, and acts of kindness) and is delivered remotely as a 5-week, Web-based intervention. Phase 2 consisted of a pilot test of EMPOWER in a single-arm trial to evaluate feasibility, acceptability, retention, and adherence and to collect data on psychosocial outcomes for proof of concept. In phase 3, we are refining study procedures and conducting a second pilot test. Results: The project was part of a career development award. Pilot work began in June 2015, and data collection was completed in March 2019. The analysis is ongoing, and results will be submitted for publication by May 2020. Conclusions: If this intervention proves feasible and acceptable, EMPOWER will be primed for a subsequent large, multisite randomized controlled trial. As a scalable intervention, it will be ideally suited for AYA survivors who would otherwise not have access to supportive care interventions to help manage posttreatment distress and enhance well-being. Trial Registration: ClinicalTrials.gov NCT02832154, https://clinicaltrials.gov/ct2/show/NCT02832154. International Registered Report Identifier (IRRID): DERR1-10.2196/17078 %M 32463014 %R 10.2196/17078 %U http://www.researchprotocols.org/2020/5/e17078/ %U https://doi.org/10.2196/17078 %U http://www.ncbi.nlm.nih.gov/pubmed/32463014 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 5 %P e14629 %T Optimization of Upper Extremity Rehabilitation by Combining Telerehabilitation With an Exergame in People With Chronic Stroke: Protocol for a Mixed Methods Study %A Allegue,Dorra Rakia %A Kairy,Dahlia %A Higgins,Johanne %A Archambault,Philippe %A Michaud,Francois %A Miller,William %A Sweet,Shane Norman %A Tousignant,Michel %+ The Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, Institut universitaire sur la réadaptation en déficience physique de Montréal, 6300 Avenue de Darlington, Montreal, QC, H3S 2J4, Canada, 1 4389901309, dorra.rakia.allegue@umontreal.ca %K stroke %K rehabilitation %K virtual reality %K telerehabilitation %K upper extremity %K motivation %D 2020 %7 21.5.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Exergames have the potential to provide an accessible, remote approach for poststroke upper extremity (UE) rehabilitation. However, the use of exergames without any follow-up by a health professional could lead to compensatory movements during the exercises, inadequate choice of difficulty level, exercises not being completed, and lack of motivation to pursue exercise programs, thereby decreasing their benefits. Combining telerehabilitation with exergames could allow continuous adjustment of the exercises and monitoring of the participant’s completion and adherence. At present, there is limited evidence regarding the feasibility or efficacy of combining telerehabilitation and exergames for stroke rehabilitation. Objective: This study aims to (1) determine the preliminary efficacy of using telerehabilitation combined with exergames on UE motor recovery, function, quality of life, and motivation in participants with chronic stroke, compared with conventional therapy (the graded repetitive arm supplementary program; GRASP); (2) examine the feasibility of using the technology with participants diagnosed with stroke at home; and (3) identify the obstacles and facilitators for its use by participants diagnosed with stroke and stroke therapists and understand the shared decision-making process. Methods: A mixed methods study protocol is proposed, including a randomized, blinded feasibility trial with an embedded multiple case study. The intervention consists of the provision of a remote rehabilitation program, during which participants will use the Jintronix exergame for UE training and the Reacts Application to conduct videoconferenced sessions with the therapists (physical or occupational therapists). We plan to recruit 52 participants diagnosed with stroke, randomly assigned to a control group (n=26; 2-month on-paper home exercise program: the GRASP with no supervision) and an experimental group (n=26; 2-month home program using the technology). The primary outcome is the Fugl-Meyer UE Assessment, a performance-based measure of UE impairment. The secondary outcomes are self-reported questionnaires and include the Motor Activity Log-28 (quality and frequency of use of the UE), Stroke Impact Scale-16 (the quality of life), and Treatment Self-Regulation Questionnaire (motivation). Feasibility data include process, resources, management, and scientific outcomes. Qualitative data will be collected by interviews with both participants and therapists. Results: At present, data collection was ongoing with one participant who had completed the exergame- telerehabilitation based intervention. We expect to collect preliminary efficacy data of this technology on the functional and motor recovery of the UE, following a stroke; collect feasibility data with users at home (adherence, safety, and technical difficulties); and identify the obstacles and facilitators for the technology use and understand the shared decision-making process. Conclusions: This paper describes the protocol underlying the study of a telerehabilitation-exergame technology to contribute to understanding its feasibility and preliminary efficacy for UE stroke rehabilitation. Trial Registration: ClinicalTrials.gov NCT03759106; http://clinicaltrials.gov/show/NCT03759106. International Registered Report Identifier (IRRID): DERR1-10.2196/14629 %M 32097119 %R 10.2196/14629 %U http://www.researchprotocols.org/2020/5/e14629/ %U https://doi.org/10.2196/14629 %U http://www.ncbi.nlm.nih.gov/pubmed/32097119 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 5 %P e15178 %T A Smartphone App–Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial %A Subnis,Utkarsh B %A Farb,Norman AS %A Piedalue,Katherine-Ann Laura %A Speca,Michael %A Lupichuk,Sasha %A Tang,Patricia A %A Faris,Peter %A Thoburn,Mark %A Saab,Bechara J %A Carlson,Linda E %+ Department of Oncology, University of Calgary, 2202 2 Street SW, Calgary, AB, T2S 3C1, Canada, 1 4034762465, utkarsh.subnis@ucalgary.ca %K mobile health %K psycho-oncology %K mindfulness %K mind-body therapies %D 2020 %7 11.5.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app–based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience. Objective: The SEAMLESS (Smartphone App–Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship—MBCS—Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors. Methods: This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users’ engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology. Results: The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques. Conclusions: Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today’s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide. Trial Registration: ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000 International Registered Report Identifier (IRRID): DERR1-10.2196/15178 %M 32390591 %R 10.2196/15178 %U https://www.researchprotocols.org/2020/5/e15178 %U https://doi.org/10.2196/15178 %U http://www.ncbi.nlm.nih.gov/pubmed/32390591 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 4 %P e15168 %T Implementation and Effects of Information Technology-Based and Print-Based Interventions to Promote Physical Activity Among Community-Dwelling Older Adults: Protocol for a Randomized Crossover Trial %A Pischke,Claudia R %A Voelcker-Rehage,Claudia %A Peters,Manuela %A Ratz,Tiara %A Pohlabeln,Hermann %A Meyer,Jochen %A von Holdt,Kai %A Lippke,Sonia %+ Institute of Medical Sociology, Centre for Health and Society, Medical Faculty, University of Duesseldorf, Moorenstrasse 5, Duesseldorf, 40225, Germany, 49 49 211 81 ext 08599, claudiaruth.pischke@med.uni-duesseldorf.de %K physical activity %K older adults %K eHealth %K print intervention %K IT-based intervention %K physical activity promotion %K healthy aging %K preferences %K randomized trial %D 2020 %7 27.4.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite the known health benefits of physical activity (PA), less than half and less than one-third of older adults in Germany reach the PA recommendations for endurance training and strength training, respectively, of the World Health Organization. The aim of this study is to investigate the implementation and effectiveness over the course of 9 months of two interventions (information technology [IT]-based vs print-based) for PA promotion among initially inactive older adults in a randomized, crossover trial. This study is part of a large research consortium (2015-2021) investigating different aspects of PA promotion. The IT-based intervention was previously developed and refined, while the print-based intervention was newly developed during this funding phase. Objective: We aim to compare the effectiveness and examine the preferences of study participants regarding both delivery modes. Methods: Our target sample size was 390 initially inactive community-dwelling older adults aged ≥60 years at baseline (3-month follow-up [T1]: expected n=300; 9-month follow-up [T2]: expected n=240) who were randomized to one of two interventions for self-monitoring PA: IT-based (50%) or print-based (50%) intervention. In addition, 30% of the IT-based intervention group received a PA tracker. At T1, participants in both groups could choose whether they prefered to keep their assigned intervention or cross over to the other group for the following 6 months (T2). Participants’ intervention preferences at baseline were collected retrospectively to run a post hoc matched-mismatched analysis. During the initial 3-month intervention period, both intervention groups were offered weekly group sessions that were continued monthly between T1 and T2. A self-administered questionnaire and 3D accelerometers were employed to assess changes in PA between baseline, T1, and T2. Adherence to PA recommendations, attendance at group sessions, and acceptance of the interventions were also tracked. Results: The funding period started in February 2018 and ends in January 2021. We obtained institutional review board approval for the study from the Medical Association in Bremen on July 3, 2018. Data collection was completed on January 31, 2020, and data cleaning and analysis started in February 2020. We expect to publish the first results by the end of the funding period. Conclusions: Strategies to promote active aging are of particular relevance in Germany, as 29% of the population is projected to be ≥65 years old by 2030. Regular PA is a key contributor to healthy aging. This study will provide insights into the acceptance and effectiveness of IT-based vs print-based interventions to promote PA in initially inactive individuals aged ≥60 years. Results obtained in this study will improve the existing evidence base on the effectiveness of community-based PA interventions in Germany and will inform efforts to anchor evidence-based PA interventions in community structures and organizations via an allocation of permanent health insurance funds. Trial Registration: German Registry of Clinical Trials DRKS00016073; https://tinyurl.com/y983586m International Registered Report Identifier (IRRID): DERR1-10.2196/15168 %M 32338622 %R 10.2196/15168 %U https://www.researchprotocols.org/2020/4/e15168 %U https://doi.org/10.2196/15168 %U http://www.ncbi.nlm.nih.gov/pubmed/32338622 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 4 %P e16799 %T The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a Randomized Feasibility Trial %A Carrier,Marie-Eve %A Kwakkenbos,Linda %A Nielson,Warren R %A Fedoruk,Claire %A Nielsen,Karen %A Milette,Katherine %A Pope,Janet %A Frech,Tracy %A Gholizadeh,Shadi %A Hummers,Laura %A Johnson,Sindhu R %A Piotrowski,Pamela %A Jewett,Lisa %A Gordon,Jessica %A Chung,Lorinda %A Bilsker,Dan %A Turner,Kimberly A %A Cumin,Julie %A Welling,Joep %A Fortune,Catherine %A Leite,Catarina %A Gottesman,Karen %A Sauve,Maureen %A Rodríguez-Reyna,Tatiana S %A Hudson,Marie %A Larche,Maggie %A van Breda,Ward %A Suarez-Almazor,Maria E %A Bartlett,Susan J %A Malcarne,Vanessa L %A Mayes,Maureen D %A Boutron,Isabelle %A Mouthon,Luc %A Wigley,Fredrick %A Thombs,Brett D %A , %+ Lady Davis Institute of the Jewish General Hospital, 4333 Cote Ste-Catherine Road, Montreal, QC, H3T 1E4, Canada, 1 5143408222 ext 25112, brett.thombs@mcgill.ca %K feasibility studies %K scleroderma, systemic %K self-management %K trial protocols %D 2020 %7 24.4.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. Objective: The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. Methods: The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ≤7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. Results: Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. Conclusions: The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. International Registered Report Identifier (IRRID): DERR1-10.2196/16799 %M 32329747 %R 10.2196/16799 %U http://www.researchprotocols.org/2020/4/e16799/ %U https://doi.org/10.2196/16799 %U http://www.ncbi.nlm.nih.gov/pubmed/32329747 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 2 %P e16294 %T A Web-Based Human Papillomavirus Vaccination Intervention for Young Gay, Bisexual, and Other Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial %A Reiter,Paul L %A Gower,Amy L %A Kiss,Dale E %A Malone,Molly A %A Katz,Mira L %A Bauermeister,Jose A %A Shoben,Abigail B %A Paskett,Electra D %A McRee,Annie-Laurie %+ The Ohio State University College of Public Health, Cunz Hall, 1841 Neil Ave, Room 359B, Columbus, OH, 43210, United States, 1 6142924803, reiter.36@osu.edu %K human papillomavirus %K human papillomavirus vaccination %K gay or bisexual %K men who have sex with men %K intervention %K young adult %D 2020 %7 24.2.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Gay, bisexual, and other men who have sex with men experience several disparities related to human papillomavirus (HPV) infection, including high incidence rates of anal cancer. Although the HPV vaccine is currently recommended for young adults, HPV vaccine coverage is modest among young gay, bisexual, and other men who have sex with men (YGBMSM). Objective: We describe the design and methods for a randomized controlled trial (RCT) to rigorously evaluate Outsmart HPV, a population-targeted, individually tailored, Web-based HPV vaccination intervention for YGBMSM. The RCT is designed to determine the efficacy of the intervention, the mechanism by which the intervention has an effect (ie, mediation), and whether efficacy varies by participant characteristics (ie, moderation). Methods: Outsmart HPV was previously developed and pilot-tested. This study is a 3-arm prospective RCT that will enroll a projected 1995 YGBMSM who are aged 18 to 25 years, live in the United States, and have not received any doses of the HPV vaccine. Participants will be recruited by means of paid advertisements on social media sites and randomized to receive (1) standard information on the Web about HPV vaccine (control group), (2) Outsmart HPV content on the Web with monthly unidirectional vaccination reminders sent via text messages, or (3) Outsmart HPV content on the Web with monthly interactive vaccination reminders sent via text messages. Participants will complete Web-based surveys at 4 time points during the study: baseline, immediately after engaging with Web-based content, 3 months after randomization, and 9 months after randomization. Primary outcomes will include both HPV vaccine initiation (ie, receipt of 1 or more doses of the HPV vaccine) and completion (receipt of all 3 doses recommended for this age range). We will examine constructs from the intervention’s theoretical framework as potential mediators and demographic and health-related characteristics as potential moderators of intervention effects. Results: The institutional review board at The Ohio State University has approved the study. Materials have been developed and finalized for all study groups. Recruitment for the RCT began in fall 2019. Conclusions: If shown to be efficacious, Outsmart HPV has the potential to fill an important gap by promoting HPV vaccination among a population at increased risk of HPV infection and HPV-related disease. Trial Registration: ClinicalTrials.gov NCT04032106; http://clinicaltrials.gov/show/NCT04032106 International Registered Report Identifier (IRRID): PRR1-10.2196/16294 %M 32130192 %R 10.2196/16294 %U http://www.researchprotocols.org/2020/2/e16294/ %U https://doi.org/10.2196/16294 %U http://www.ncbi.nlm.nih.gov/pubmed/32130192 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 2 %P e15781 %T A Mobile Intervention to Improve Uptake of Pre-Exposure Prophylaxis for Southern Black Men Who Have Sex With Men: Protocol for Intervention Development and Pilot Randomized Controlled Trial %A Rouffiac,Anne-Emilie %A Whiteley,Laura %A Brown,Larry %A Mena,Leandro %A Craker,Lacey %A Healy,Meredith %A Haubrick,Kayla %+ Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, 222 Richmond Street, Providence, RI, United States, 1 401 455 6375, laura_whiteley@brown.edu %K pre-exposure prophylaxis (PrEP) %K HIV prevention %K men who have sex with men (MSM) %D 2020 %7 20.2.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The uptake of pre-exposure prophylaxis (PrEP) has been slow for young black men who have sex with men (BMSM) living in the southern United States. This is a significant issue because 8 of the 10 states with the highest rates of new HIV infections are in the South. Jackson, Mississippi (MS), the site of this project, has the second highest AIDS diagnosis rate in the nation and the highest rate of HIV infection for young, urban BMSM. This study will develop and test an engaging, interactive, and cost-effective mobile messaging intervention to improve engagement in PrEP care for BMSM aged 18 to 35 years living in Jackson, MS. Objective: The goals of this mixed methods study are to (1) conduct qualitative interviews with young BMSM in Jackson, MS, to understand individual, community, and structural barriers affecting engagement in PrEP-related care, (2) assemble a PrEP mobile messaging intervention that includes text messages with publicly available internet content (websites and YouTube videos) that provide factual information, motivational materials, and behavioral skills related to PrEP and HIV prevention, and (3) evaluate the preliminary efficacy of the intervention in a randomized controlled study with PrEP-eligible BMSM receiving care in STI/HIV testing clinics in Jackson, MS. Methods: This research protocol will be conducted in 2 phases. A development phase will involve in-depth interviews (n=30) with PrEP-eligible BMSM who receive care in STI/HIV testing clinics in MS. These interviews will allow researchers to select the texted material that will be sent out during the intervention. The second phase will consist of an unblinded, small, randomized controlled trial among 66 new participants to examine the preliminary efficacy of the intervention compared with enhanced standard of care (ESC) on attendance at a PrEP services appointment (the first step in initiating PrEP care) and receipt of a PrEP prescription, based on self-report and electronic medical records. The free, publicly available material will be sent to PrEP-eligible BMSM in 8 to 16 interactive text messages over 4 weeks. Study assessments will occur at enrollment and at 4- and 16-weeks postenrollment and can be completed online or in person. All participants will be recruited from a local clinic. Results: Institutional review board approval was received on January 16, 2017, and research activities, subsequently, began in February 2018. Recruitment for the study concluded in November 2019. In total, 65 participants were randomized with 33 being assigned to the intervention and 32 to ESC. Collection of follow-up data is ongoing. Conclusions: This PrEP mobile messaging intervention aims to increase uptake of PrEP by BMSM in the southern United States. This intervention uses interactive, tailored text messaging and appealing free Web content (publicly accessible educational websites and YouTube videos) to promote linkage to PrEP care and increase HIV preventative behaviors. A cost-effective PrEP mobile messaging intervention has great potential to improve information about PrEP, improve motivation to use PrEP, and decrease stigma and structural barriers that often prevent engagement in PrEP-related medical care. Trial Registration: ClinicalTrials.gov NCT03308097; https://clinicaltrials.gov/ct2/show/NCT03308097 International Registered Report Identifier (IRRID): DERR1-10.2196/15781 %M 32130196 %R 10.2196/15781 %U http://www.researchprotocols.org/2020/2/e15781/ %U https://doi.org/10.2196/15781 %U http://www.ncbi.nlm.nih.gov/pubmed/32130196 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 1 %P e15022 %T Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease %A Rawstorn,Jonathan Charles %A Ball,Kylie %A Oldenburg,Brian %A Chow,Clara K %A McNaughton,Sarah A %A Lamb,Karen Elaine %A Gao,Lan %A Moodie,Marj %A Amerena,John %A Nadurata,Voltaire %A Neil,Christopher %A Cameron,Stuart %A Maddison,Ralph %+ Institute for Physical Activity and Nutrition, Deakin University, Locked Bag 20001, Geelong, 3220, Australia, 61 392468461, jonathan.rawstorn@deakin.edu.au %K telemedicine %K telerehabilitation %K mHealth %K myocardial ischemia %K coronary artery disease %K exercise %K behavioral medicine %K health services accessibility %K costs and cost analysis %D 2020 %7 27.1.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. Objective: The aim of this study is to compare the effects and costs of the innovative Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) intervention with usual care CR. Methods: In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. Results: The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. Conclusions: The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. International Registered Report Identifier (IRRID): DERR1-10.2196/15022 %M 32012103 %R 10.2196/15022 %U https://www.researchprotocols.org/2020/1/e15022 %U https://doi.org/10.2196/15022 %U http://www.ncbi.nlm.nih.gov/pubmed/32012103 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 1 %P e14810 %T Self-Management Characterization for Families of Children With Medical Complexity and Their Social Networks: Protocol for a Qualitative Assessment %A Valdez,Rupa S %A Lunsford,Christopher %A Bae,Jiwoon %A Letzkus,Lisa C %A Keim-Malpass,Jessica %+ School of Nursing, University of Virginia, PO Box 800782, Charlottesville, VA, 22908, United States, 1 4342433961, jlk2t@virginia.edu %K children with medical complexity %K care coordination %K social network %K qualitative description %K health care self-management %K family management %K multiadic analysis %K contextual environment %D 2020 %7 23.1.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children with medical complexity (CMC) present rewarding but complex challenges for the health care system. Transforming high-quality care practices for this population requires multiple stakeholders and development of innovative models of care. Importantly, care coordination requires significant self-management by families in home- and community-based settings. Self-management often requires that families of CMC rely on vast and diverse social networks, encompassing both online and offline social relationships with individuals and groups. The result is a support network surrounding the family to help accomplish self-management of medical tasks and care coordination. Objective: The goal of this study is to use a theoretically driven perspective to systematically elucidate the range of self-management experiences across families of CMC embedded in diverse social networks and contextual environments. This approach will allow for characterization of the structure and process of self-management of CMC with respect to social networks, both in person and digitally. This research proposal aims to address the significant gaps in the self-management literature surrounding CMC, including the following: (1) how self-management responsibilities are distributed and negotiated among the social network and (2) how individual-, family-, and system-level factors influence self-management approaches for CMC from a theoretically driven perspective. Methods: This study will encompass a qualitative descriptive approach to understand self-management practices among CMC and their social networks. Data collection and analysis will be guided by a theoretical and methodological framework, which synthesizes perspectives from nursing, human factors engineering, public health, and family counseling. Data collection will consist of semistructured interviews with children, parents, and social network members, inclusive of individuals such as friends, neighbors, and community members, as well as online communities and individuals. Data analysis will consist of a combination of inductive and deductive methods of qualitative content analysis, which will be analyzed at both individual and multiadic levels, where interview data from two or more individuals, focused on the same experience, will be comparatively analyzed. Results: This study will take approximately 18 months to complete. Our long-term goals are to translate the qualitative analysis into (1) health IT design guidance for innovative approaches to self-management and (2) direct policy guidance for families of CMC enrolled in Medicaid and private insurance. Conclusions: Multiple innovative components of this study will enable us to gain a comprehensive and nuanced understanding of the lived experience of self-management of CMC. In particular, by synthesizing and applying theoretical and methodological approaches from multiple disciplines, we plan to create novel informatics and policy solutions to support their care within home and community settings. International Registered Report Identifier (IRRID): PRR1-10.2196/14810 %M 32012094 %R 10.2196/14810 %U http://www.researchprotocols.org/2020/1/e14810/ %U https://doi.org/10.2196/14810 %U http://www.ncbi.nlm.nih.gov/pubmed/32012094 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 1 %P e15753 %T A Mobile Phone–Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial %A Seto,Emily %A Ross,Heather %A Tibbles,Alana %A Wong,Steven %A Ware,Patrick %A Etchells,Edward %A Kobulnik,Jeremy %A Chibber,Tamanna %A Poon,Stephanie %+ Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Toronto, ON, M5T 3M6, Canada, 1 4166699295, emily.seto@utoronto.ca %K heart failure %K telemedicine %K mobile phone %K patient monitoring %K randomized controlled trial %D 2020 %7 22.1.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone–based TM system that is currently being used as a standard of care for HF at a large Canadian hospital, may be an effective tool for the management of HF in patients recently discharged from hospital. Objective: The objective of the Medly-After an Incidence of acute Decompensation (Medly-AID) trial is to determine the effect of Medly on the self-care and quality of life of patients with HF who have been recently discharged from hospital after an HF-related decompensation. Methods: A multisite multimethod randomized controlled trial (RCT) will be conducted at 2 academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of patients with HF who had been hospitalized for HF-related decompensation and discharged during the 2 weeks before recruitment. The trial will include 144 participants with HF (74 in each control and intervention groups). Control patients will receive standard of care, whereas patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will record daily weight, blood pressure, and heart rate and answer symptom-related questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and send real-time alerts to their health care providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires Self-Care of Heart Failure Index, EQ-5D-5L, and the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcome measures for this study include cost of health care services used and health outcomes. Results: Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre, with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020. Conclusions: This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. Trial Registration: ClinicalTrials.gov NCT03358303; https://clinicaltrials.gov/ct2/show/NCT03358303 International Registered Report Identifier (IRRID): DERR1-10.2196/15753 %M 32012116 %R 10.2196/15753 %U https://www.researchprotocols.org/2020/1/e15753 %U https://doi.org/10.2196/15753 %U http://www.ncbi.nlm.nih.gov/pubmed/32012116 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 1 %P e16417 %T The Use of Web-Based Support Groups Versus Usual Quit-Smoking Care for Men and Women Aged 21-59 Years: Protocol for a Randomized Controlled Trial %A Pechmann,Cornelia Ann %A Calder,Douglas %A Phillips,Connor %A Delucchi,Kevin %A Prochaska,Judith J %+ The Paul Merage School of Business, University of California, Irvine, 4293 Pereira Dr, Irvine, CA, 92697, United States, 1 3108920619, cpechman@uci.edu %K smoking prevention %K support group %K cigarettes %K tobacco %D 2020 %7 14.1.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Existing smoking cessation treatments are challenged by low engagement and high relapse rates, suggesting the need for more innovative, accessible, and interactive treatment strategies. Twitter is a Web-based platform that allows people to communicate with each other throughout the day using their phone. Objective: This study aims to leverage the social media platform of Twitter for fostering peer-to-peer support to decrease relapse with quitting smoking. Furthermore, the study will compare the effects of coed versus women-only groups on women’s success with quitting smoking. Methods: The study design is a Web-based, three-arm randomized controlled trial with two treatment arms (a coed or women-only Twitter support group) and a control arm. Participants are recruited online and are randomized to one of the conditions. All participants will receive 8 weeks of combination nicotine replacement therapy (patches plus their choice of gum or lozenges), serial emails with links to Smokefree.gov quit guides, and instructions to record their quit date online (and to quit smoking on that date) on a date falling within a week of initiation of the study. Participants randomized to a treatment arm are placed in a fully automated Twitter support group (coed or women-only), paired with a buddy (matched on age, gender, location, and education), and encouraged to communicate with the group and buddy via daily tweeted discussion topics and daily automated feedback texts (a positive tweet if they tweet and an encouraging tweet if they miss tweeting). Recruited online from across the continental United States, the sample consists of 215 male and 745 female current cigarette smokers wanting to quit, aged between 21 and 59 years. Self-assessed follow-up surveys are completed online at 1, 3, and 6 months after the date they selected to quit smoking, with salivary cotinine validation at 3 and 6 months. The primary outcome is sustained biochemically confirmed abstinence at the 6-month follow-up. Results: From November 2016 to September 2018, 960 participants in 36 groups were recruited for the randomized controlled trial, in addition to 20 participants in an initial pilot group. Data analysis will commence soon for the randomized controlled trial based on data from 896 of the 960 participants (93.3%), with 56 participants lost to follow-up and 8 dropouts. Conclusions: This study combines the mobile platform of Twitter with a support group for quitting smoking. Findings will inform the efficacy of virtual peer-to-peer support groups for quitting smoking and potentially elucidate gender differences in quit rates found in prior research. Trial Registration: ClinicalTrials.gov NCT02823028; https://clinicaltrials.gov/ct2/show/NCT02823028 International Registered Report Identifier (IRRID): DERR1-10.2196/16417 %M 31934869 %R 10.2196/16417 %U https://www.researchprotocols.org/2020/1/e16417 %U https://doi.org/10.2196/16417 %U http://www.ncbi.nlm.nih.gov/pubmed/31934869 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 1 %P e16275 %T Effects of Bluetooth-Enabled Desk Ellipticals on Office Work Performance: Rationale, Design, and Protocol for a Randomized Trial With Overweight and Obese Adults %A Rovniak,Liza S %A Adams,Marc A %A Sciamanna,Christopher N %A Kong,Lan %A Sullivan,Nicole %A Costalas,Sara %A Bopp,Melissa %A Kuzmik,Ashley %+ Division of General Internal Medicine, Departments of Medicine and Public Health Sciences, Pennsylvania State University College of Medicine, 500 University Dr, Hershey, PA, 17033, United States, 1 7175318161, lrovniak@pennstatehealth.psu.edu %K physical activity %K obesity %K reinforcement %K environment design %K built environment %K occupational health %K workplace %K mHealth %D 2020 %7 14.1.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Workplaces that provide opportunities for physical activity without requiring extra time for activity could help counteract the obesity epidemic. Desk ellipticals can contribute to activity-supportive workplace environments; however, the feasibility of engaging employees in pedaling ellipticals during simultaneous office work has not been well evaluated. Objective: We aim to present the rationale and methods from an ongoing randomized trial with overweight and obese employees that will evaluate (1) the effects of pedaling a compact desk elliptical on work performance and (2) the influence of different incentive types and schedules on desk pedaling quantity. Methods: Overweight and obese medical center employees are being recruited in dyads for a 2 (gift card type: healthier food vs Amazon) by 3 (gift card schedule: immediate incentive contingent on individual pedaling quantity; immediate incentive partially contingent on dyads’ joint pedaling quantity; and delayed noncontingent pedaling incentive) cluster randomized within-subjects factorial trial. All participants receive a Bluetooth-enabled desk elliptical for 4 weeks and access to a mobile app that provides real-time pedaling feedback. The primary aims are to assess (1) change in employee work performance from pre- to postelliptical installation via employee and supervisor ratings and (2) effects of gift card type and schedule on quantity of objectively measured desk pedaling completed. Results: Data collection is ongoing. We expect to complete main outcome analyses in 2020. Conclusions: This trial represents one of the earliest attempts to assess the effects of desk pedaling and pedaling-incentive types in real-world offices. It could help bridge the research-to-practice gap by providing evidence on whether desk pedaling can be sustained without compromising work performance. International Registered Report Identifier (IRRID): DERR1-10.2196/16275 %M 31934871 %R 10.2196/16275 %U https://www.researchprotocols.org/2020/1/e16275 %U https://doi.org/10.2196/16275 %U http://www.ncbi.nlm.nih.gov/pubmed/31934871 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 1 %P e15058 %T Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support %A Gumley,Andrew %A Bradstreet,Simon %A Ainsworth,John %A Allan,Stephanie %A Alvarez-Jimenez,Mario %A Beattie,Louise %A Bell,Imogen %A Birchwood,Max %A Briggs,Andrew %A Bucci,Sandra %A Castagnini,Emily %A Clark,Andrea %A Cotton,Sue M %A Engel,Lidia %A French,Paul %A Lederman,Reeva %A Lewis,Shon %A Machin,Matthew %A MacLennan,Graeme %A Matrunola,Claire %A McLeod,Hamish %A McMeekin,Nicola %A Mihalopoulos,Cathrine %A Morton,Emma %A Norrie,John %A Reilly,Frank %A Schwannauer,Matthias %A Singh,Swaran P %A Smith,Lesley %A Sundram,Suresh %A Thomson,David %A Thompson,Andrew %A Whitehill,Helen %A Wilson-Kay,Alison %A Williams,Christopher %A Yung,Alison %A Farhall,John %A Gleeson,John %+ Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Fleming Pavilion, West of Scotland Science Park (Todd Campus), Glasgow, G20 0XA, United Kingdom, 44 141 330 4852, a.gumley@clinmed.gla.ac.uk %K schizophrenia %K psychosis %K relapse %K mHealth %K randomized controlled trial %D 2020 %7 9.1.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. Objective: This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. Methods: We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. Results: Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. Conclusions: The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID): DERR1-10.2196/15058 %M 31917372 %R 10.2196/15058 %U https://www.researchprotocols.org/2020/1/e15058 %U https://doi.org/10.2196/15058 %U http://www.ncbi.nlm.nih.gov/pubmed/31917372 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 12 %P e14555 %T Improving Oral Health in Older Adults and People With Disabilities: Protocol for a Community-Based Clinical Trial (Good Oral Health) %A Schensul,Jean %A Reisine,Susan %A Grady,James %A Li,Jianghong %+ Institute for Community Research, 146 Wyllys St, Hartford, CT, 06106-1986, United States, 1 860 278 2044 ext 227, Jean.schensul@icrweb.org %K oral health %K elderly %K oral hygiene %K prevention %K clinical trial %K crossover design %D 2019 %7 18.12.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Low-income older adults experience disparities in oral health problems, including caries and periodontal disease, that can exacerbate already high levels of chronic and acute health problems. Behavioral interventions have been shown to improve oral health status but are typically administered in institutional rather than community settings. Furthermore, multiple simultaneous interventions at different levels in the locations where people live and work are likely to have more impact and sustainability than single interventions in clinical settings. Objective: This paper outlines a protocol for conducting a bilingual 5-year community-based trial of a bilevel intervention that addresses community norms, beliefs, intentions, and practices to improve oral health hygiene of vulnerable older adults living in publicly subsidized housing. The intervention utilizes (1) a face-to-face counseling approach (adapted motivational interviewing [AMI]) and (2) resident-run oral health campaigns in study buildings. Methods: The study’s modified fractional factorial crossover design randomizes 6 matched buildings into 2 conditions: AMI followed by campaign (AB) and campaign followed by AMI (BA). The total intervention cycle is approximately 18 months in duration. The design compares the 2 interventions alone (T0-T1), and in different sequences (T1-T2), using a self-reported survey and clinical assessment to measure Plaque Score (PS) and Gingival Index (GI) as outcomes. A final timepoint (T3), 6 months post T2, assesses sustainability of each sequence. The intervention is based on the Fishbein integrated model that includes both individual and contextual modifiers, norms and social influence, beliefs, attitudes, efficacy, and intention as predictors of improvements in PS, GI, and oral health quality of life. The cognitive and behavioral domains in the intervention constitute the mechanisms through which the intervention should have a positive effect. They are tailored through the AMI and targeted to building populations through the peer-facilitated oral health campaigns. The sample size is 360, 180 in each condition, with an attrition rate of 25%. The study is funded by National Institute of Dental and Craniofacial Research (NIDCR) and has been reviewed by University of Connecticut and NIDCR institutional review boards and NIDCR’s clinical trials review procedures. Results: When compared against each other, the face-to-face intervention is expected to have greater positive effects on clinical outcomes and oral health quality of life through the mediators. When sequences are compared, the results may be similar but affected by different mediators. The arm consisting of the BA is expected to have better sustainability. The protocol’s unique features include the comparative effectiveness crossover design; the introduction of new emotion-based mediators; the balancing of fidelity, tailoring, and targeting; and resident engagement in the intervention. Conclusions: If successful, the evaluated interventions can be scaled up for implementation in other low-income congregate living and recreational settings with older adult collectives. Trial Registration: ClinicalTrials.gov NCT02419144; https://clinicaltrials.gov/ct2/show/NCT02419144 International Registered Report Identifier (IRRID): DERR1-10.2196/14555 %M 31850853 %R 10.2196/14555 %U https://www.researchprotocols.org/2019/12/e14555 %U https://doi.org/10.2196/14555 %U http://www.ncbi.nlm.nih.gov/pubmed/31850853 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 12 %P e14339 %T An Electronic Health Intervention for Latina Women Undergoing Breast Cancer Treatment (My Guide for Breast Cancer Treatment): Protocol for a Randomized Controlled Trial %A Yanez,Betina %A Baik,Sharon H %A Oswald,Laura B %A Buitrago,Diana %A Buscemi,Joanna %A Iacobelli,Francisco %A Perez-Tamayo,Alejandra %A Fajardo,Precilla %A Serrano,Gabriela %A Guitelman,Judith %A Penedo,Frank J %+ Northwestern University Feinberg School of Medicine, 633 N Saint Clair St, Chicago, IL, 60611-3234, United States, 1 312 503 5341, betina.yanez@northwestern.edu %K breast cancer %K Latina %K health-related quality of life %K eHealth %K randomized controlled trial %D 2019 %7 13.12.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Among Latinas and Hispanics (henceforth referred to as Latinas), breast cancer is the most commonly diagnosed cancer and the leading cause of cancer-related deaths. However, few interventions have been developed to meet the needs of Latina women undergoing active treatment for breast cancer. Objective: This paper aims to describe the procedures and methods of My Guide for Breast Cancer Treatment and the plans for conducting a multisite randomized controlled trial to investigate the feasibility and preliminary efficacy of this smartphone-based app for Latina women in active treatment for breast cancer. Methods: Study participants will be randomized to the My Guide for Breast Cancer Treatment intervention or the enhanced usual care control condition for 12 weeks. Participants will have access to innovative features such as gamification via virtual awards to reinforce usage and an adaptive section that presents targeted material based on their self-reported concerns and needs. Using a stepped-care approach, intervention participants will also receive telecoaching to enhance their adherence to the app. Study outcomes and intervention targets will be measured at study enrollment (before randomization), 6 and 12 weeks after initial app use. General and disease-specific health-related quality of life (HRQoL) and symptom burden are the study’s primary outcomes, whereas anxiety, depression, fear of cancer recurrence, physical activity, and dietary intake are secondary outcomes. Results: Recruitment began in August 2019 and is expected to be completed by August 2020. We expect to submit study results for publication by fall 2020. Conclusions: My Guide for Breast Cancer Treatment has the potential to improve HRQoL and reduce symptom burden, and increase access to supportive care resources among Latina breast cancer patients. International Registered Report Identifier (IRRID): PRR1-10.2196/14339 %M 31833834 %R 10.2196/14339 %U https://www.researchprotocols.org/2019/12/e14339 %U https://doi.org/10.2196/14339 %U http://www.ncbi.nlm.nih.gov/pubmed/31833834 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 11 %P e15530 %T Delivering a Post-Partum Weight Loss Intervention via Facebook or In-Person Groups: Protocol for a Randomized Feasibility Pilot Trial %A Waring,Molly E %A Libby,Brooke A %A Moore Simas,Tiffany A %A Bracken,Madison L %A Bibeau,Jessica L %A Herrera,Valeria %A Wang,Justin %A Pagoto,Sherry L %+ Department of Allied Health Sciences, UConn Center for mHealth and Social Media, University of Connecticut, 358 Mansfield Road, Unit 1101, Storrs, CT, 06269, United States, 1 8604861446, molly.waring@uconn.edu %K postpartum period %K weight loss %K social media %K pilot study %D 2019 %7 28.11.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Postpartum weight retention contributes to long-term weight gain and obesity for many women. Lifestyle interventions with numerous visits are logistically challenging for many postpartum women. Delivering a lifestyle intervention via social media may overcome logistic challenges to participation in in-person weight loss programs. Objective: The objective of this study is to conduct a randomized feasibility pilot trial of a 6-month postpartum weight loss intervention delivered via Facebook or in-person groups with 72 postpartum women with overweight or obesity. Methods: Women with overweight or obesity who are 8 weeks to 12 months postpartum (N=72) will be recruited from the Hartford, Connecticut community. Eligible participants must also own an iPhone or Android smartphone and be an active Facebook user. Participants will receive a 6-month postpartum weight loss intervention based on the Diabetes Prevention Program lifestyle intervention and adapted for postpartum women. Participants will be randomized to receive the intervention via a private Facebook group or in-person group meetings. Assessments will occur at baseline, weekly during the intervention, at 6 months (at the end of the intervention), and at 12 months. Primary feasibility outcomes are recruitment, sustained participation, contamination, retention, and feasibility of assessment procedures including measurement of costs to deliver and receive the intervention. We will describe 6- and 12-month weight loss as an exploratory outcome. Results: Recruitment began in September 2018. The first wave of the intervention began in February 2019, and the second wave of the intervention is expected to begin in fall 2019. We anticipate completing follow-up assessments in fall 2020, and results will be analyzed at that time. Conclusions: Results will inform the design of a large randomized controlled trial to assess whether delivering a postpartum weight loss intervention via Facebook is noninferior for weight loss and more cost-effective than delivering the intervention via traditional in-person groups. International Registered Report Identifier (IRRID): DERR1-10.2196/15530 %M 31778116 %R 10.2196/15530 %U http://www.researchprotocols.org/2019/11/e15530/ %U https://doi.org/10.2196/15530 %U http://www.ncbi.nlm.nih.gov/pubmed/31778116 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 11 %P e15155 %T Social Media Intervention to Promote Smoking Treatment Utilization and Cessation Among Alaska Native People Who Smoke: Protocol for the Connecting Alaska Native People to Quit Smoking (CAN Quit) Pilot Study %A Sinicrope,Pamela S %A Koller,Kathryn R %A Prochaska,Judith J %A Hughes,Christine A %A Bock,Martha J %A Decker,Paul A %A Flanagan,Christie A %A Merritt,Zoe T %A Meade,Crystal D %A Willetto,Abbie L %A Resnicow,Ken %A Thomas,Timothy K %A Patten,Christi A %+ Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, United States, 1 507 266 1238, Sinicrope.Pamela@mayo.edu %K smoking %K tobacco cessation %K Alaska %K Alaska Natives %K tobacco smoking %K internet %K social media %K clinical trial randomized %K smoking cessation %K intervention %D 2019 %7 22.11.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite the high prevalence of tobacco use among Alaska Native (AN) people, tobacco cessation interventions developed specifically for this group are lacking. Social media hold promise as a scalable intervention strategy to promote smoking treatment utilization and cessation, given the barriers to treatment delivery (ie, geographic remoteness, limited funding, climate, and travel costs) in the state of Alaska (AK). Building on a longstanding tobacco control research partnership with the AK Tribal Health System, in this study, we are developing and pilot-testing a culturally relevant, Facebook (FB)-delivered intervention that incorporates a digital storytelling approach adapted from the effective Centers for Disease Control Tips from Former Smokers campaign. Objective: This study aims to promote evidence-based smoking treatment (eg, state quitline and Tribal cessation programs) uptake and cessation among AN people. Methods: This study fulfills the objectives for stage 1 of the National Institute on Drug Abuse behavioral integrative treatment development program. In stage 1a, we will use a mixed method approach to develop the FB intervention. Cultural variance and surface/deep structure frameworks will address the influence of culture in designing health messages. These developmental activities will include qualitative and quantitative assessments, followed by beta testing of proposed intervention content. In stage 1b, we will conduct a randomized pilot trial enrolling 60 AN adults who smoke. We will evaluate the feasibility, uptake, consumer response, and potential efficacy of the FB intervention compared with a control condition (quitline/treatment referral only). Primary outcome measures include feasibility and biochemically verified smoking abstinence at 1-, 3-, and 6-month follow-ups. Secondary outcomes will include self-reported smoking cessation treatment utilization and abstinence from tobacco/nicotine products. We will also explore interdependence (relationship orientation and collaborative efforts in lifestyle change) as a culturally relevant mediator of intervention efficacy. Results: The study enrolled 40 participants for phase 1, with data saturation being achieved at 30 AN people who smoke and 10 stakeholders. For phase 2, we enrolled 40 participants. Qualitative assessment of proposed intervention content was completed with 30 AN smokers and 10 stakeholders. We are currently analyzing data from the quantitative assessment with 40 participants in preparation for the beta testing, followed by the randomized pilot trial. Conclusions: The project is innovative for its use of social media communication tools that are culturally relevant in a behavioral intervention designed to reach AN people statewide to promote smoking treatment utilization and cessation. The study will further advance tobacco cessation research in an underserved disparity group. If the pilot intervention is successful, we will have a blueprint to conduct a large randomized controlled efficacy trial. Our approach could be considered for other remote AN communities to enhance the reach of evidence-based tobacco cessation treatments. International Registered Report Identifier (IRRID): DERR1-10.2196/15155 %M 31755867 %R 10.2196/15155 %U http://www.researchprotocols.org/2019/11/e15155/ %U https://doi.org/10.2196/15155 %U http://www.ncbi.nlm.nih.gov/pubmed/31755867 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 10 %P e14106 %T An Online Minimally Guided Intervention to Support Family and Other Unpaid Carers of People With Dementia: Protocol for a Randomized Controlled Trial %A Pinto-Bruno,Ángel C %A Pot,Anne Margriet %A Kleiboer,Annet %A Droes,Rose-Marie %A van Straten,Annemieke %+ Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT Room: MF-A525, Amsterdam, Netherlands, 31 20 598 67 27, a.c.pintobruno@vu.nl %K informal carers %K dementia %K ICT intervention %K online %K perceived stress %D 2019 %7 10.10.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: About three-quarters of people with dementia live in their own homes, with help from family members and/or other unpaid carers, such as friends or neighbors. Often, unpaid carers themselves experience negative consequences, such as stress, burden, and symptoms of depression or anxiety. Research has shown that these consequences can be alleviated by psychosocial and psychological interventions. Moreover, there are indications that those interventions can be effective when offered online. Objective: This paper describes the protocol of a randomized controlled trial (RCT) that will take place in the Netherlands to evaluate the effectiveness of iSupport, a minimally guided, internet-based intervention to improve carers’ mental health and coping resources. Methods: A superiority two-arm RCT comparing the effects of the online support program with a waiting list control condition will be carried out in the Netherlands. The iSupport intervention was developed by the World Health Organization and is based on cognitive behavioral therapy principles. It has five main themes divided into 23 lessons. Carers can pick and choose which lessons they want to complete. We aim to recruit 200 unpaid carers. The experimental group (n=100) will be provided with access to the intervention for 3 months following randomization; those in the waiting list control group (n=100) will be granted access to the intervention after 3 months. Assessments will be conducted at baseline (T0), 3 months after baseline (post intervention, T1), and 6 months after baseline (follow-up, T2). The primary outcome is perceived stress, measured by the Perceived Stress Scale. Secondary outcomes are symptoms of depression and anxiety, caregiver burden, sense of competence, self-efficacy, mastery, and carers’ attitudes toward dementia and their person-centered approach (ie, to what extent carers tailor the provided care to the interest, needs, and history of the person with dementia). Results: Recruitment for the trial started in January 2019. As of July 2019, we have enrolled 120 participants. Data collection is expected to be completed by March 2020. Once all the data have been collected, we will conduct the data analyses between April and May 2020. We aim to publish our results in a manuscript by June 2020. Conclusions: Online interventions have shown promising results in improving the mental health of carers of people with dementia. Additionally, online interventions may overcome accessibility barriers. If successful, this intervention will have important potential for implementation as a public health intervention, since costs and support by trained staff are minimal. Trial Registration: Netherlands Trial Register (NTL) NL6417; https://www.trialregister.nl/trial/6417 International Registered Report Identifier (IRRID): DERR1-10.2196/14106 %M 31603433 %R 10.2196/14106 %U http://www.researchprotocols.org/2019/10/e14106/ %U https://doi.org/10.2196/14106 %U http://www.ncbi.nlm.nih.gov/pubmed/31603433 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 10 %P e13738 %T Personalized, Web-Based, Guided Self-Help for Patients With Medically Unexplained Symptoms in Primary Care: Protocol for a Randomized Controlled Trial %A van Gils,Anne %A Hanssen,Denise %A van Asselt,Antoinette %A Burger,Huibert %A Rosmalen,Judith %+ Interdisciplinary Center Psychopathology and Emotion Regulation, University Medical Center Groningen, University of Groningen, PO Box 30001, Groningen, 9700 RB, Netherlands, 31 503612287, a.van.gils@umcg.nl %K medically unexplained symptoms %K somatoform disorders %K precision medicine %K eHealth %K general practice %D 2019 %7 8.10.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Medically unexplained symptoms (MUS) constitute a major health problem because of their high prevalence, the suffering and disability they cause, and the associated medical costs. Web-based interventions may provide an accessible and convenient tool for managing MUS. We developed a personalized, Web-based, guided self-help intervention for MUS in primary care (Grip self-help) and would compare its effectiveness with that of usual care. Objective: This paper aims to describe the rationale, objectives, and design of a pragmatic randomized controlled trial (RCT) assessing the effectiveness of Grip self-help. Methods: For a pragmatic multicenter RCT, 165 adult patients with mild to moderate MUS will be recruited through general practices in the Netherlands. Randomization will be performed at general practice level. Over the course of several months, patients in the intervention group will receive a personalized set of Web-based self-help exercises, targeting the unhelpful cognitions, emotions, behaviors, and social factors that are relevant to them. The intervention is guided by a general practice mental health worker. The control group will receive care-as-usual. Primary outcome is physical health-related quality of life (RAND-36 or 36-item general health survey, physical component score). Secondary outcomes include severity of physical and psychological symptoms, mental health–related quality of life, cost-effectiveness, and acceptability. Assessments will take place at baseline, end of treatment, and at 16-, 26-, and 52-week follow-ups. Results: Recruitment started in December 2018, and enrolment is ongoing. The first results are expected to be submitted for publication in December 2021. Conclusions: To our knowledge, this is the first study to combine the concepts of electronic health, self-help, and personalized medicine in the treatment of MUS. By improving the quality of life and reducing symptoms of patients with MUS, Grip self-help has the potential to reduce costs and conserve scarce health care resources. Trial Registration: Dutch Trial Register NTR7390; https://www.trialregister.nl/trial/7390. International Registered Report Identifier (IRRID): PRR1-10.2196/13738 %M 31596246 %R 10.2196/13738 %U https://www.researchprotocols.org/2019/10/e13738 %U https://doi.org/10.2196/13738 %U http://www.ncbi.nlm.nih.gov/pubmed/31596246 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 10 %P e13557 %T Children Immunization App (CImA) Among Syrian Refugees in Zaatari Camp, Jordan: Protocol for a Cluster Randomized Controlled Pilot Trial Intervention Study %A Khader,Yousef S %A Laflamme,Lucie %A Schmid,Daniela %A El-Halabi,Soha %A Abu Khdair,Mohammad %A Sengoelge,Mathilde %A Atkins,Salla %A Tahtamouni,Manal %A Derrough,Tarik %A El-Khatib,Ziad %+ Department of Public Health Sciences, Karolinska Institutet, Stockholm,, Sweden, 46 6643461861, ziad.khatib@gmail.com %K mHealth %K refugees %K vaccines %K Jordan %K Syria %D 2019 %7 7.10.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: There are up to 19.4 million children who are still unvaccinated and face unnecessary deaths, especially among refugees. However, growing access to smartphones, among refugees, can be a leading factor to improve vaccination rates. Objective: This study aims to determine whether a smartphone app can improve the vaccination uptake among refugees and determine the app’s effectiveness in improving the documentation of vaccination records. Methods: We developed and planned to test an app through a cluster randomized trial that will be carried out at the Zaatari refugee camp in Jordan. The study will be open to all parents who carry Android smartphones, have at least one child, and agree to participate in the study. The parents will be recruited to the study by trained volunteers at the vaccination sites around the Zaatari camp. Inclusion criteria will be the following: having at least one child of 0 to 5 years, being a local resident of the camp, and having an Android smartphone. Results: The intervention includes an app that will allow storing Jordanian vaccination records, per child, on the parents’ smartphones in Arabic and English (in an interchangeable fashion). Every record will have a set of automated reminders before the appointment of each child. The app will summarize immunization records in form of due, taken, or overdue appointments, labeled in orange, green, and red, respectively. Baseline will include the collection of our primary and secondary outcomes that are needed for the pre and postdata measurements. This includes social demographic data, any previous vaccination history, and electronic health literacy. Participants, in both study arms, will be monitored for their follow-up visits to the clinic for vaccination doses. For the study outcome measures, we will measure any differences in the uptake of vaccinations. The secondary outcome is to analyze the effect of the children immunization app on visits for follow-up doses. Conclusions: Owing to the limited evidence of effective interventions for childhood vaccination among refugees, research in this area is greatly needed. The project will have a significant impact on the health of refugees and the public health system. In Jordan and the Middle East, the vaccination level is low. Given the influx of refugees from the area, it is crucial to ensure a high vaccination level among the children. International Registered Report Identifier (IRRID): PRR1-10.2196/13557 %M 31593549 %R 10.2196/13557 %U https://www.researchprotocols.org/2019/10/e13557 %U https://doi.org/10.2196/13557 %U http://www.ncbi.nlm.nih.gov/pubmed/31593549 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 10 %P e13821 %T Improving Transplant Medication Safety Through a Technology and Pharmacist Intervention (ISTEP): Protocol for a Cluster Randomized Controlled Trial %A Hall,Casey L %A Fominaya,Cory E %A Gebregziabher,Mulugeta %A Milfred-LaForest,Sherry K %A Rife,Kelsey M %A Taber,David J %+ Health Equity & Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, 109 Bee Street, Charleston, SC, 29401, United States, 1 843 789 7759, casey.hall3@va.gov %K transplant %K adherence %K medication adherence %K medication errors %D 2019 %7 1.10.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Medication errors, adverse drug events, and nonadherence lead to increased health care utilization and increased risk of adverse clinical outcomes, including graft loss, in solid organ transplant recipients. Veterans living with organ transplants represent a population that is at substantial risk for medication safety events and fragmented care coordination issues. To improve medication safety and long-term clinical outcomes in veteran transplant patients, interventions should address interorganizational system failures and provider-level and patient-level factors. Objective: This study aims to measure the clinical and economic effectiveness of a pharmacist-led, technology-enabled intervention, compared with usual care, in veteran organ transplant recipients. Methods: This is a 24-month prospective, parallel-arm, cluster-randomized, controlled multicenter study. The pharmacist-led intervention uses an innovative dashboard system to improve medication safety and health outcomes, compared with usual posttransplant care. Pharmacists at 10 study sites will be consented into this study before undergoing randomization, and 5 sites will then be randomized to each study arm. Approximately, 1600 veteran transplant patients will be included in the assessment of the primary outcome across the 10 sites. Results: This study is ongoing. Institutional review board approval was received in October 2018 and the study opened in March 2019. To date there are no findings from this study, as the delivery of the intervention is scheduled to occur over a 24-month period. The first results are expected to be submitted for publication in August 2021. Conclusions: With this report, we describe the study design, methods, and outcome measures that will be used in this ongoing clinical trial. Successful completion of the Improving Transplant Medication Safety through a Technology and Pharmacist Intervention study will provide empirical evidence of the effectiveness of a feasible and scalable technology-enabled intervention on improving medication safety and costs. Clinical Trial: ClinicalTrials.gov NCT03860818; https://clinicaltrials.gov/ct2/show/NCT03860818 International Registered Report Identifier (IRRID): PRR1-10.2196/13821 %M 31573933 %R 10.2196/13821 %U https://www.researchprotocols.org/2019/10/e13821 %U https://doi.org/10.2196/13821 %U http://www.ncbi.nlm.nih.gov/pubmed/31573933 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 9 %P e14853 %T Health Disparities in Staphylococcus aureus Transmission and Carriage in a Border Region of the United States Based on Cultural Differences in Social Relationships: Protocol for a Survey Study %A Pearson,Talima %A Barger,Steven D %A Lininger,Monica %A Wayment,Heidi %A Hepp,Crystal %A Villa,Francisco %A Tucker-Morgan,Kara %A Kyman,Shari %A Cabrera,Melissa %A Hurtado,Kevin %A Menard,Ashley %A Fulbright,Kelly %A Wood,Colin %A Mbegbu,Mimi %A Zambrano,Yesenia %A Fletcher,Annette %A Medina-Rodriguez,Sarah %A Manone,Mark %A Aguirre,Amanda %A Milner,Trudie %A Trotter II,Robert T %+ Pathogen & Microbiome Institute, Northern Arizona University, 1395 S Knoles Dr, Flagstaff, AZ, 86001, United States, 1 9285234290, talima.pearson@nau.edu %K S aureus carriage %K S aureus transmission %K community acquired S aureus transmission %K social determinants of health %K social network analysis %K border health %K health disparities in minority communities %D 2019 %7 27.9.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Health care–associated Staphylococcus aureus infections are declining but remain common. Conversely, rates of community-associated infections have not decreased because of the inadequacy of public health mechanisms to control transmission in a community setting. Our long-term goal is to use risk-based information from empirical socio-cultural-biological evidence of carriage and transmission to inform intervention strategies that reduce S aureus transmission in the community. Broad differences in social interactions because of cultural affiliation, travel, and residency patterns may impact S aureus carriage and transmission, either as risk or as protective factors. Objective: This study aims to (1) characterize S aureus carriage rates and compare circulating pathogen genotypes with those associated with disease isolated from local clinical specimens across resident groups and across Hispanic and non-Hispanic white ethnic groups and (2) evaluate social network relationships and social determinants of health-based risk factors for their impact on carriage and transmission of S aureus. Methods: We combine sociocultural survey approaches to population health sampling with S aureus carriage and pathogen genomic analysis to infer transmission patterns. Whole genome sequences of S aureus from community and clinical sampling will be phylogenetically compared to determine if strains that cause disease (clinical samples) are representative of community genotypes. Phylogenetic comparisons of strains collected from participants within social groups can indicate possible transmission within the group. We can therefore combine transmission data with social determinants of health variables (socioeconomic status, health history, etc) and social network variables (both egocentric and relational) to determine the extent to which social relationships are associated with S aureus transmission. Results: We conducted a first year pilot test and feasibility test of survey and biological data collection and analytic procedures based on the original funded design for this project (#NIH U54MD012388). That design resulted in survey data collection from 336 groups and 1337 individuals. The protocol, described below, is a revision based on data assessment, new findings for statistical power analyses, and refined data monitoring procedures. Conclusions: This study is designed to evaluate ethnic-specific prevalence of S aureus carriage in a US border community. The study will also examine the extent to which kin and nonkin social relationships are concordant with carriage prevalence in social groups. Genetic analysis of S aureus strains will further distinguish putative transmission pathways across social relationship contexts and inform our understanding of the correspondence of S aureus reservoirs across clinical and community settings. Basic community-engaged nonprobabilistic sampling procedures provide a rigorous framework for completion of this 5-year study of the social and cultural parameters of S aureus carriage and transmission. %M 31573953 %R 10.2196/14853 %U https://www.researchprotocols.org/2019/9/e14853 %U https://doi.org/10.2196/14853 %U http://www.ncbi.nlm.nih.gov/pubmed/31573953 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 9 %P e14096 %T The Use of Virtual and Immersive Technology in Creating Personalized Multisensory Spaces for People Living With Dementia (SENSE-GARDEN): Protocol for a Multisite Before-After Trial %A Goodall,Gemma %A Ciobanu,Ileana %A Taraldsen,Kristin %A Sørgaard,Jon %A Marin,Andreea %A Draghici,Rozeta %A Zamfir,Mihai-Viorel %A Berteanu,Mihai %A Maetzler,Walter %A Serrano,J Artur %+ Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, , Trondheim,, Norway, 47 40554367, gemma.goodall@ntnu.no %K dementia %K emotions %K technology %K multimedia %K eHealth %D 2019 %7 19.8.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The number of people living with dementia is rapidly increasing. With dementia’s impact on memory, communication, and self-identity, it is important to identify ways of meeting individual needs of diagnosed individuals and their caregivers. This study will test a new intervention, SENSE-GARDEN, that integrates autobiographical music, films, pictures, and scents with innovative technology to create an immersive environment tailored specifically for the individual. Objective: The SENSE-GARDEN study is an Active Assisted Living Program–funded multicenter project. The primary objective of the study is to assess whether a personalized, innovative technology-based intervention can improve the well-being of older adults living with moderate to severe dementia. The study will also assess whether the intervention can improve coping and reduce burden in caregivers. Methods: A controlled before-after study design will be used. There will be 3 sites in 3 trial countries: Belgium, Norway, and Portugal. A total of 55 people with dementia (PWDs) will be recruited. All eligible participants for the study will be randomized into the intervention or control group. For the first three months of the study, all participants will receive the SENSE-GARDEN intervention. For the final month of the study, the intervention group will continue visits to the SENSE-GARDEN, and the control group will discontinue visits. A mixed-methods approach will be used, including the use of standardized outcome measures, quantitative physiological data, and qualitative interview data. Results: The trials commenced recruitment in August 2019, and all data are expected to be collected by the end of May 2020. A user-centered design process is underway, with results from the first phase of user interviews indicating that people with mild cognitive impairment, family caregivers, and professional caregivers consider the SENSE-GARDEN to be a potentially valuable tool in providing numerous benefits to dementia care. Feasibility testing of the SENSE-GARDEN has been completed and results are expected to be published in October 2019. Conclusions: Findings from the SENSE-GARDEN trials will provide insights into the use of technology for personalizing interventions to the PWD. This will have potential implications on not only dementia research, but it may also have influences on care practice. International Registered Report Identifier (IRRID): DERR1-10.2196/14096 %M 31538942 %R 10.2196/14096 %U https://www.researchprotocols.org/2019/9/e14096 %U https://doi.org/10.2196/14096 %U http://www.ncbi.nlm.nih.gov/pubmed/31538942 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 9 %P e13656 %T The Effectiveness of Educational Mobile Messages for Assisting in the Prevention of Early Childhood Caries: Protocol for a Randomized Controlled Trial %A Aguirre,Patricia Estefania Ayala %A Lotto,Matheus %A Strieder,Anna Paola %A Cruvinel,Agnes Fátima Pereira %A Cruvinel,Thiago %+ Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru,, Brazil, 55 1432358318, thiagocruvinel@fob.usp.br %K eHealth %K dental caries %K randomized controlled trial %D 2019 %7 03.09.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: In 2017, approximately 3.7 billion downloads of health apps were made on mobile phones and tablets. In this sense, a massive number of people could benefit by electronic mobile–based health interventions, making information available even with the lack of material and human resources. Hence, the use of electronic apps for dental education might be extremely useful for the prevention of early childhood caries (ECC). Objective: This study aims to evaluate the effectiveness of messages sent via mobile phones as an adjuvant method for the prevention of ECC. Methods: A single-blinded, randomized, and parallel-group clinical trial will be conducted with dyads of parents or caregivers and children aged between 36 and 60 months, recruited from kindergartens and schools of Bauru, São Paulo. The determination of sample size resulted in a total of 104 dyads of parents and children, considering a power of 80%, a significance level of 5%, and an attrition of 30%. This sample will be randomly assigned to test and control groups, being divided in 52 dyads per group according to the health literacy levels of parents and the age, gender, and oral health status of children. Every 2 weeks, only participants in the test group will receive messages via WhatsApp containing preventive and education-related ECC information. The dyads will visit the dentist every 3 months during a year for the assessment of primary outcomes (sugar consumption and the International Caries Detection and Assessment System, visible plaque, and community periodontal indices) and to receive dental care measures. Secondary outcomes (electronic health literacy and general perceived self-efficacy) will be determined only at baseline and after 12-month follow-up. The quality of randomization will be evaluated throughout the study, comparing the test and control groups systematically by Student t tests for continuous variables and chi-square tests for categorical variables. Listwise deletion method will be applied in cases of dropouts, if the missing values satisfy the criteria of missing completely at random; otherwise, multiple imputation data strategy will be conducted. The Kolmogorov-Smirnov and Levene tests will be used to determine the normality and homogeneity of data, respectively, which will indicate further statistical analyses for elucidating significant differences between groups (P<.05). A Student t test or Mann-Whitney U test will be employed for parametric or nonparametric analyses, respectively. Results: The project was funded in 2018, and enrollment was completed in August 2019. Allocation is currently under way and the first results are expected to be submitted for publication in 2020. Conclusions: The results will contribute to understanding the importance of educational mobile messages toward the adoption of healthy behaviors for the prevention of ECC in a given population. Trial Registration: Brazilian Registry of Clinical Trials Universal Trial Number U1111-1216-1393; http://www.ensaiosclinicos.gov.br/rg/RBR-2b6r7q/ International Registered Report Identifier (IRRID): PRR1-10.2196/13656 %M 31482856 %R 10.2196/13656 %U https://www.researchprotocols.org/2019/9/e13656/ %U https://doi.org/10.2196/13656 %U http://www.ncbi.nlm.nih.gov/pubmed/31482856 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 8 %P e13214 %T Examining the Impact of a Personalized Self-Management Lifestyle Program Using Mobile Technology on the Health and Well-Being of Cancer Survivors: Protocol and Rationale for a Randomized Controlled Trial (The Moving On Study) %A Groarke,Jenny M %A Richmond,Janice %A Kelly,Mary Grace %A McSharry,Jenny %A Groarke,AnnMarie %A Kerr,Tommy %A Singaroyan,Nina %A Harney,Owen %A Haughey,Charlene %A Glynn,Liam %A Masterson,Eimear %A O Donnell,Aoife %A Duffy,Karen %A Walsh,Jane %+ School of Psychology, Queen's University Belfast, Belfast, UK, David Keir Building, Belfast,, United Kingdom, 44 0289097 ext 4886, j.groarke@qub.ac.uk %K mHealth %K SMS %K activity tracker %K behavior change technique %K health behavior change %K obesity %K cancer %D 2019 %7 23.08.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cancer survivorship in Ireland is increasing in both frequency and longevity. However, a significant proportion of cancer survivors are overweight. This has negative implications for long-term health outcomes, including increased risk of subsequent and secondary cancers. There is a need to identify interventions, which can improve physical and psychological outcomes that are practical in modern oncology care. Mobile health (mHealth) interventions demonstrate potential for positive health behavior change, but there is little evidence for the efficacy of mobile technology to improve health outcomes in cancer survivors. Objective: This study aims to investigate whether a personalized mHealth self-management lifestyle program is acceptable to participants and can improve physical and psychological outcomes of a subgroup of cancer survivors with increased health risks related to lifestyle behaviors. Methods: A sample of 123 cancer survivors (body mass index >25 kg/m2) was randomly assigned to the control (n=61) or intervention (n=62) group. The intervention group attended a 4-hour tailored lifestyle information session with a physiotherapist, dietician, and clinical psychologist to support self-management of health behavior. Over the following 12 weeks, participants engaged in personalized goal setting to incrementally increase physical activity (with feedback and review of goals through short message service text messaging contact). Objective measures of health behavior (ie, physical activity) were collected using Fitbit (Fitbit, Inc). Data on anthropometric, physiological, dietary behavior, and psychological measures were collected at baseline (T0), 12 weeks (T1; intervention end), and 24 weeks (T2; follow-up). Semistructured interviews were conducted to explore the retrospective acceptability of the Moving On program from the perspective of the recipients. Results: This paper details the protocol for the Moving On study. The project was funded in August 2017. Enrolment started in December 2017. Data collection completed in September 2018. Data analysis is underway, and results are expected in winter 2019. Conclusions: The results of this study will determine the efficacy and acceptability of an mHealth intervention using behavior change techniques to promote health behaviors that support physical health and well-being in cancer survivors and will therefore have implications for health care providers, patients, health psychologists, and technologists. International Registered Report Identifier (IRRID): DERR1-10.2196/13214 %M 31444876 %R 10.2196/13214 %U http://www.researchprotocols.org/2019/8/e13214/ %U https://doi.org/10.2196/13214 %U http://www.ncbi.nlm.nih.gov/pubmed/31444876 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 8 %P e14571 %T A Mobile App to Support Parents Making Child Mental Health Decisions: Protocol for a Feasibility Cluster Randomized Controlled Trial %A Liverpool,Shaun %A Webber,Helen %A Matthews,Rob %A Wolpert,Miranda %A Edbrooke-Childs,Julian %+ Faculty of Life Sciences, University College London, , London,, United Kingdom, 44 2031089888, shaun.liverpool.14@ucl.ac.uk %K shared decision making %K mental health %K child %K adolescent %K parents %K technology %D 2019 %7 14.08.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Shared decision making (SDM) is recognized as a person-centered approach to improving health care quality and outcomes. Few digital interventions to improve SDM have been tested in child and adolescent mental health (CAMH) settings. One such intervention is Power Up, a mobile phone app for young people (YP), which has shown some evidence of promise that YP who received Power Up reported greater levels of SDM. However, even though parents play a critical role in CAMH care and treatment, they often feel excluded from services. Objective: This protocol is for a pilot trial to determine the feasibility of a large-scale randomized trial to develop and evaluate a Web app called Power Up for Parents (PUfP) to support parents and promote involvement in CAMH decisions. Methods: A 2-stage process, consisting of the development stage and pilot-testing stage of the initial PUfP prototype, will be conducted. At the development stage, a qualitative study with parents and clinicians will be conducted. The interviews will aim to capture the experience of making CAMH decisions, preferences for involvement in SDM, and determine situations within which PUfP can be useful. At the pilot-testing stage, up to 90 parents and their clinicians will be invited to participate in the testing of the prototype. Parents will be randomly allocated to receive the intervention or be part of the control group. This study design will allow us to assess the acceptability and usefulness of PUfP in addition to examining the feasibility of a prospective randomized trial. Clinicians’ perceptions of the prototype and how it has influenced parents’ involvement in SDM will also be examined. Results: Recruitment began in January 2019 and is scheduled to last for 10 months. Interviews and baseline data collection are currently in progress. To date, 11 CAMH sites have been recruited to take part in the study. It is anticipated that data collection will be completed by October 2019. Conclusions: The lack of parents’ involvement in CAMH care and treatment can lead to higher rates of dropout from care and lower adherence to therapeutic interventions. There are significant benefits to be gained globally if digital SDM interventions are adopted by parents and shown to be successful in CAMH settings. Trial Registration: ISRCTN Registry ISRCTN39238984; http://www.isrctn.com/ISRCTN39238984 International Registered Report Identifier (IRRID): DERR1-10.2196/14571 %M 31414665 %R 10.2196/14571 %U https://www.researchprotocols.org/2019/8/e14571/ %U https://doi.org/10.2196/14571 %U http://www.ncbi.nlm.nih.gov/pubmed/31414665 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 8 %P e12620 %T A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial %A Hochstatter,Karli R %A Gustafson Sr,David H %A Landucci,Gina %A Pe-Romashko,Klaren %A Maus,Adam %A Shah,Dhavan V %A Taylor,Quinton A %A Gill,Emma K %A Miller,Rebecca %A Krechel,Sarah %A Westergaard,Ryan P %+ Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin-Madison, 1685 Highland Ave, 5th Floor, Madison, WI, 53705, United States, 1 608 265 9611, khochsta@medicine.wisc.edu %K mHealth %K eHealth %K hepatitis C virus %K substance use %K continuum of care %D 2019 %7 01.08.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: People who inject drugs are at a disproportionate risk for contracting hepatitis C virus (HCV). However, use of HCV prevention and treatment services remains suboptimal among people with substance use disorders due to various health system, societal, and individual barriers. Mobile health applications offer promising strategies to support people in recovery from substance use disorders. We sought to determine whether the Addiction-Comprehensive Health Enhancement Support System (A-CHESS), an existing mobile health application for opioid use disorder, could be adapted to improve HCV screening and treatment. Objective: The goals of this paper are to describe: (1) the components and functionality of an HCV intervention incorporated into the existing A-CHESS system; and (2) how data are collected and will be used to evaluate HCV testing, linkage to care, and treatment. Methods: People with recent opioid use were enrolled in a randomized controlled trial to test whether A-CHESS reduced relapse. We developed and implemented HCV intervention content within the A-CHESS platform to simultaneously evaluate whether A-CHESS improved secondary outcomes related to HCV care. All A-CHESS users received the HCV intervention content, which includes educational information, private messages tailored to an individual’s stage of HCV care, and a public discussion forum. Data on patients’ HCV risk behaviors and stage of care were collected through quarterly telephone interviews and weekly surveys delivered through A-CHESS. The proportion of people with opioid use disorder who are HCV untested, HCV-negative, HCV antibody-positive, or HCV RNA–positive, as well as linked to care, treated and cured at baseline is described here. The 24-month follow-up is ongoing and will be completed in April 2020. Survey data will then be used to assess whether individuals who received the HCV-enhanced A-CHESS intervention were more likely to reduce risky injection behaviors, receive HCV testing, link to medical care, initiate treatment, and be cured of HCV compared to the control group. Results: Between April 2016 and April 2018, 416 individuals were enrolled and completed the baseline interview. Of these individuals, 207 were then randomly assigned to the control arm and 209 were assigned to the intervention arm. At baseline, 202 individuals (49%) self-reported ever testing HCV antibody-positive. Of those, 179 (89%) reported receiving HCV RNA confirmatory testing, 134 (66%) tested HCV RNA–positive, 125 (62%) were linked to medical care and 27 (13%) were treated and cured of HCV. Of the remaining 214 individuals who had never tested HCV antibody–positive, 129 (31%) had tested HCV antibody–negative within the past year and 85 (20%) had not been tested within the past year. Conclusions: The A-CHESS mobile health system allows for the implementation of a bundle of services as well as the collection of longitudinal data related to drug use and HCV care among people with opioid use disorders. This study will provide preliminary evidence to determine whether HCV-specific services embedded into the A-CHESS program can improve HCV outcomes for people engaged in addiction treatment. Trial Registration: ClinicalTrials.gov NCT02712034; https://clinicaltrials.gov/ct2/show/NCT02712034 International Registered Report Identifier (IRRID): DERR1-10.2196/12620 %M 31373273 %R 10.2196/12620 %U https://www.researchprotocols.org/2019/8/e12620/ %U https://doi.org/10.2196/12620 %U http://www.ncbi.nlm.nih.gov/pubmed/31373273 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 7 %P e12837 %T Text Messaging to Improve Linkage, Retention, and Health Outcomes Among HIV-Positive Young Transgender Women: Protocol for a Randomized Controlled Trial (Text Me, Girl!) %A Reback,Cathy J %A Fletcher,Jesse B %A Fehrenbacher,Anne E %A Kisler,Kimberly %+ Friends Research Institute, Inc, 1419 North La Brea Avenue, Los Angeles, CA, 90028, United States, 1 323 463 2295, reback@friendsresearch.org %K HIV %K AIDS %K transgender persons %K text messaging %D 2019 %7 29.07.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Transgender women in the United States experience numerous risk factors for HIV acquisition and transmission, including increased rates of homelessness, alcohol and drug use, sex work, and nonprescribed hormone and soft tissue–filler injections. In addition, transgender women face discrimination and social/economic marginalization more intense and deleterious than that experienced by lesbian, gay, or bisexual individuals, further worsening health outcomes. Although little research has been done specifically with young transgender women aged 35 years and younger, existing evidence suggests even further elevated rates of homelessness, substance use, and engagement in HIV transmission risk behaviors relative to their older transgender women and nontransgender young adult counterparts. Young transgender women living with HIV experience a range of barriers that challenge their ability to be successfully linked and retained in HIV care. Objective: The aim of this randomized controlled trial, Text Me, Girl!, is to assess the impact of a 90-day, theory-based, transgender-specific, text-messaging intervention designed to improve HIV-related health outcomes along the HIV care continuum among young (aged 18-34 years) transgender women (N=130) living with HIV/AIDS. Methods: Participants were randomized into either Group A (immediate text message intervention delivery; n=61) or Group B (delayed text message intervention delivery whereby participants were delivered the text-messaging intervention after a 90-day delay period; n=69). Over the course of the 90-day intervention, participants received 270 theory-based text messages that were targeted, tailored, and personalized specifically for young transgender women living with HIV. Participants received 3 messages per day in real time within a 10-hour gradual and automated delivery system. The text-message content was scripted along the HIV care continuum and based on social support theory, social cognitive theory, and health belief model. The desired outcome of Text Me, Girl! was virological suppression. Results: Recruitment began on November 18, 2016, and the first participant was enrolled on December 16, 2016; enrollment closed on May 31, 2018. Intervention delivery ended on November 30, 2018, and follow-up evaluations will conclude on August 31, 2019. Primary outcome analyses will begin immediately following the conclusion of the follow-up evaluations. Conclusions: Text messaging is a communication platform well suited for engaging young transgender women in HIV care because it is easily accessible and widely used, as well as private, portable, and inexpensive. Text Me, Girl! aimed to improve HIV care continuum outcomes among young transgender women by providing culturally responsive text messages to promote linkage, retention, and adherence, with the ultimate goal of achieving viral suppression. The Text Me, Girl! text message library is readily scalable and can be adapted for other hard-to-reach populations. International Registered Report Identifier (IRRID): DERR1-10.2196/12837 %M 31359867 %R 10.2196/12837 %U http://www.researchprotocols.org/2019/7/e12837/ %U https://doi.org/10.2196/12837 %U http://www.ncbi.nlm.nih.gov/pubmed/31359867 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 7 %P e14814 %T Dissemination and Effectiveness of the Peer Marketing and Messaging of a Web-Assisted Tobacco Intervention: Protocol for a Hybrid Effectiveness Trial %A Faro,Jamie M %A Orvek,Elizabeth A %A Blok,Amanda C %A Nagawa,Catherine S %A McDonald,Annalise J %A Seward,Gregory %A Houston,Thomas K %A Kamberi,Ariana %A Allison,Jeroan J %A Person,Sharina D %A Smith,Bridget M %A Brady,Kathleen %A Grosowsky,Tina %A Jacobsen,Lewis L %A Paine,Jennifer %A Welch Jr,James M %A Sadasivam,Rajani S %+ Division of Health Informatics and Implementation Science, Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, The Albert Sherman Center, 368 Plantation Street, Worcester, MA, 01605, United States, 1 (774) 455 3744, Jamie.faro@umassmed.edu %K smoking cessation %K peer recruitment %K digital Intervention %K tailored, dissemination %D 2019 %7 23.07.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Smoking continues to be the leading preventable cause of death. Digital Interventions for Smoking Cessation (DISCs) are health communication programs accessible via the internet and smartphones and allow for greater reach and effectiveness of tobacco cessation programs. DISCs have led to increased 6-month cessation rates while also reaching vulnerable populations. Despite this, the impact of DISCs has been limited and new ways to increase access and effectiveness are needed. Objective: We are conducting a hybrid effectiveness-dissemination study. We aim to evaluate the effectiveness of a machine learning–based approach (recommender system) for computer-tailored health communication (CTHC) over a standard CTHC system based on quit rates and risk reduction. In addition, this study will assess the dissemination of providing access to a peer recruitment toolset on recruitment rate and variability of the sample. Methods: The Smoker-to-Smoker (S2S) study is a 6-month hybrid effectiveness dissemination trial conducted nationally among English-speaking, current smokers aged ≥18 years. All eligible participants will register for the DISC (Decide2quit) and be randomized to the recommender system CTHC or the standard CTHC, followed by allocation to a peer recruitment toolset group or control group. Primary outcomes will be 7-day point prevalence and risk reduction at the 6-month follow-up. Secondary outcomes include recruitment rate, website engagement, and patient-reported outcomes collected via the 6-month follow-up questionnaire. All primary analyses will be conducted on an intent-to-treat basis. Results: The project is funded from 2017 to 2020 by the Patient Centered Outcomes Research Institute. Enrollment was completed in early 2019, and 6-month follow-ups will be completed by late 2019. Preliminary data analysis is currently underway. Conclusions: Conducting a hybrid study with both effectiveness and dissemination hypotheses raises some unique challenges in the study design and analysis. Our study addresses these challenges to test new innovations and increase the effectiveness and reach of DISCs. International Registered Report Identifier (IRRID): DERR1-10.2196/14814 %M 31339104 %R 10.2196/14814 %U http://www.researchprotocols.org/2019/7/e14814/ %U https://doi.org/10.2196/14814 %U http://www.ncbi.nlm.nih.gov/pubmed/31339104 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 6 %P e13351 %T “Smartphone Medication Adherence Saves Kidneys” for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial %A McGillicuddy,John %A Chandler,Jessica %A Sox,Luke %A Mueller,Martina %A Nemeth,Lynne %A Baliga,Prabhakar %A Treiber,Frank %+ College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas Street, Charleston, SC,, United States, 1 843 792 1928, chandlje@musc.edu %K mHealth %K kidney transplant %K medication adherence %K digital health %D 2019 %7 21.06.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Kidney transplant recipients’ poor medication adherence and poor control of comorbidities, particularly hypertension, are risk factors for graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have been successful in improving sustained medication adherence and blood pressure control among kidney transplantation recipients. We provide rationale for an RCT evaluating a mobile health medical self-management system for kidney transplantation recipients called Smartphone Medication Adherence Saves Kidneys (SMASK). Objective: Our objective is to determine whether SMASK is efficacious in improving medication adherence and sustaining blood pressure control among kidney transplantation recipients with uncontrolled hypertension and poor medication adherence compared to an enhanced standard care. Methods: This two-arm, 6-month, phase II single-site efficacy RCT will involve 80 kidney transplantation recipients. Participants will be randomly assigned to the SMASK intervention arm or control arm. SMASK includes multilevel components: automated reminders from an electronic medication tray; tailored text messages and motivational feedback, guided by the self-determination theory; and automated summary reports for providers. Evaluations will be conducted preintervention, at 3 and 6 months, and posttrial at 12 months. Specific aims are to test the hypotheses that compared to standard care, the SMASK cohort will demonstrate significantly improved changes at 3, 6, and 12 months in the primary outcome variables medication adherence (proportion with electronic monitor-derived score >0.90) and blood pressure control (proportion meeting and sustaining adherence to the Kidney Disease Improving Global Outcomes [KDIGO] guidelines for blood pressure control); the secondary outcome variables provider adherence to KDIGO guidelines, measured by timing of medication changes and changes in self-determination theory constructs; and the exploratory outcome variables estimated glomerular filtration rate, variability in calcineurin inhibitor trough levels, and proportion of patients meeting and sustaining the 24-hour ambulatory blood pressure below 130/80 mm Hg. After the 6-month evaluation, interviews with a random sample of SMASK subjects (n=20) and health care providers (n=3-5) will assess user reactions including acceptability, usability, and aids/barriers to sustainability. Data from the RCT and interviews will be triangulated to further refine and optimize SMASK and prepare for a multisite effectiveness RCT. Results: The SMASK project received funding from National Institute of Diabetes and Digestive and Kidney Diseases in June 2016, obtained institutional review board approval in April 2016, and began data collection in July 2016. As of July 2018, we completed enrollment with a total of 80 participants. Conclusions: This study will provide data regarding the efficacy of SMASK to improve medication adherence and blood pressure control in a cohort of hypertensive kidney transplant recipients. An efficacious SMASK intervention will pave the way for a larger, multicenter, effectiveness RCT powered sufficiently to evaluate clinical events in a real-world setting and with the potential to demonstrate improved outcomes at lower cost than standard care. International Registered Report Identifier (IRRID): DERR1-10.2196/13351 %M 31228175 %R 10.2196/13351 %U http://www.researchprotocols.org/2019/6/e13351/ %U https://doi.org/10.2196/13351 %U http://www.ncbi.nlm.nih.gov/pubmed/31228175 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 6 %P e11733 %T Comparing Written Versus Pictorial Asthma Action Plans to Improve Asthma Management and Health Outcomes Among Children and Adolescents: Protocol of a Pilot and Feasibility Randomized Controlled Trial %A Hynes,Lisa %A Durkin,Kristine %A Williford,Desireé N %A Smith,Hope %A Skoner,David %A Lilly,Christa %A Kothari,Viral Dilip %A Mc Sharry,Jenny %A Duncan,Christina L %+ Department of Psychology, West Virginia University, 1124 Life Sciences Building, Morgantown, WV, 26506-6040, United States, 1 3042161953, lisa.hynes@nuigalway.ie %K asthma %K child %K adolescent %K education %K self-management %D 2019 %7 17.06.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Asthma is an important focus for pediatric health research as management of asthma symptoms is a significant challenge, and morbidity and mortality among youths with asthma remain prevalent. Treatment guidelines for asthma recommend a written asthma action plan (WAAP) that summarizes individualized instructions for daily medication use. However, WAAPs are typically written at a seventh- to ninth-grade reading level, which can be a barrier to young people in understanding their treatment, having confidence in using a WAAP, and engaging with asthma education. Objective: Utilizing a feasibility and pilot randomized controlled trial (RCT) design, the objective of the Take Action for Asthma Control study is to test a symptom-based, computer-generated pictorial asthma action plan (PAAP) in comparison with a standard WAAP and assess the feasibility and acceptability of the asthma action plan (AAP) intervention and study procedures. The study has 3 aims: (1) estimate the effect sizes of PAAPs compared with WAAPs on outcomes (eg, AAP knowledge and medication adherence), (2) evaluate feasibility and acceptability of AAP intervention and RCT procedures from the perspectives of key stakeholders, and (3) establish whether parent and youth literacy levels are associated with treatment outcomes. Methods: This feasibility and pilot RCT is a block randomized, 2-arm, parallel-group clinical trial, lasting 6 months in duration. At baseline, participants will be randomly assigned to receive a PAAP or WAAP generated for them and reviewed with them by their asthma physician. Study procedures will take place over 4 separate time points: a baseline clinic appointment, 1-month telephone follow-up, and 3- and 6-month clinic-based follow-ups. At each time point, data will be collected related to the main outcomes: AAP knowledge, AAP satisfaction, asthma control, pulmonary function, and adherence to daily asthma medication. A sample size of up to 60 participants (aged 8-17 years) will be recruited. Feasibility and acceptability data will be collected via one-to-one qualitative interviews with providers involved in the study and a subgroup of families that participate in the study. Results: Recruitment and data collection began in May 2017 and were completed in October 2018. Conclusions: This pilot and feasibility study will test the potential efficacy, feasibility, and acceptability of an AAP intervention and study procedures. The findings will inform the design and delivery of a future definitive trial to assess the efficacy of PAAPs versus WAAPs in supporting asthma self-management among children and adolescents. International Registered Report Identifier (IRRID): DERR1-10.2196/11733 %M 31210140 %R 10.2196/11733 %U https://www.researchprotocols.org/2019/6/e11733/ %U https://doi.org/10.2196/11733 %U http://www.ncbi.nlm.nih.gov/pubmed/31210140 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 6 %P e12377 %T Mobile Messaging Support Versus Usual Care for People With Type 2 Diabetes on Glycemic Control: Protocol for a Multicenter Randomized Controlled Trial %A Farmer,Andrew %A Bobrow,Kirsty %A Leon,Natalie %A Williams,Nicola %A Phiri,Enita %A Namadingo,Hazel %A Cooper,Sara %A Prince,John %A Crampin,Amelia %A Besada,Donela %A Daviaud,Emmanuelle %A Yu,Ly-Mee %A Ngoma,Jonathan %A Springer,David %A Pauly,Bruno %A Norris,Shane %A Tarassenko,Lionel %A Nyirenda,Moffat %A Levitt,Naomi %+ Nuffield Department of Primary Care Health Sciences, University of Oxford, Primary Care Building, Woodstock Road, Oxford, OX2 6GG, United Kingdom, 44 1865 289280, andrew.farmer@phc.ox.ac.uk %K randomized controlled trial %K diabetes mellitus %K type 2 diabetes %K mobile health %K treatment adherence %D 2019 %7 30.5.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Health outcomes for people treated for type 2 diabetes could be substantially improved in sub-Saharan Africa. Failure to take medicine regularly to treat diabetes has been identified as a major problem. Resources to identify and support patients who are not making the best use of medicine in low- and middle-income settings are scarce. Mobile phones are widely available in these settings, including among people with diabetes; linked technologies, such as short message service (SMS) text messaging, have shown promise in delivering low-cost interventions efficiently. However, evidence showing that these interventions will work when carried out at a larger scale and measuring the extent to which they will improve health outcomes when added to usual care is limited. Objective: The objective of this trial is to test the effectiveness of sending brief, automated SMS text messages for improving health outcomes and medication adherence in patients with type 2 diabetes compared to an active control. Methods: We will carry out a randomized trial recruiting from clinics in two contrasting settings in sub-Saharan Africa: Cape Town, South Africa, and Lilongwe, Malawi. Intervention messages will advise people about the benefits of their diabetes treatment and offer motivation and encouragement around lifestyle and use of medication. We allocated patients, using randomization with a minimization algorithm, to receive either three to four intervention messages per week or non-health-related messages every 6 weeks. We will follow up with participants for 12 months, measuring important risk factors for poor health outcomes and complications in diabetes. This will enable us to estimate potential health benefits, including the primary outcome of hemoglobin A1c (HbA1c) levels as a marker for long-term blood glucose control and a secondary outcome of blood pressure control. We will record the costs of performing these activities and estimate cost-effectiveness. We will also use process evaluation to capture the collection of medication and assess the reception of the intervention by participants and health care workers. Results: Recruitment to the trial began in September 2016 and follow-up of participants was completed in October 2018. Data collection from electronic health records and other routinely collected sources is continuing. The database lock is anticipated in June 2019, followed by analysis and disclosing of group allocation. Conclusions: The knowledge gained from this study will have wide applications and advance the evidence base for effectiveness of mobile phone-based, brief text messaging on clinical outcomes and in large-scale, operational settings. It will provide evidence for cost-effectiveness and acceptability that will further inform policy development and decision making. We will work with a wide network that includes patients, clinicians, academics, industry, and policy makers to help us identify opportunities for informing people about the work and raise awareness of what is being developed and studied. Trial Registration: ISRCTN Registry ISRCTN70768808; http://www.isrctn.com/ISRCTN70768808 (Archived by WebCite at http://www.webcitation.org/786316Zqk) International Registered Report Identifier (IRRID): DERR1-10.2196/12377 %M 31199346 %R 10.2196/12377 %U https://www.researchprotocols.org/2019/6/e12377/ %U https://doi.org/10.2196/12377 %U http://www.ncbi.nlm.nih.gov/pubmed/31199346 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 5 %P e13666 %T A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial %A Haun,Jolie N %A Ballistrea,Lisa M %A Melillo,Christine %A Standifer,Maisha %A Kip,Kevin %A Paykel,Jacquelyn %A Murphy,Jennifer L %A Fletcher,Carol E %A Mitchinson,Allison %A Kozak,Leila %A Taylor,Stephanie L %A Glynn,Shirley M %A Bair,Matthew %+ Rehabilitation Outcomes Research Section, James A Haley Veterans’ Hospital and Clinics, Veterans Health Administration, 13000 Bruce B Downs Blvd, Tampa, FL,, United States, 1 813 558 7622, joliehaun@gmail.com %K health information technology %K implementation %K veteran %K complementary and integrative health %K PTSD %K pain %D 2019 %7 13.05.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Complementary and integrative health (CIH) is a viable solution to PTSD and chronic pain. Many veterans believe CIH can be performed only by licensed professionals in a health care setting. Health information technology can bring effective CIH to veterans and their partners. Objective: This paper describes the rationale, design, and methods of the Mission Reconnect protocol to deliver mobile and Web-based complementary and integrative health programs to veterans and their partners (eg, spouse, significant other, caregiver, or family member). Methods: This three-site, 4-year mixed-methods randomized controlled trial uses a wait-list control to determine the effects of mobile and Web-based CIH programs for veterans and their partners, or dyads. The study will use two arms (ie, treatment intervention arm and wait-list control arm) in a clinical sample of veterans with comorbid pain and posttraumatic stress disorder, and their partners. The study will evaluate the effectiveness and perceived value of the Mission Reconnect program in relation to physical and psychological symptoms, global health, and social outcomes. Results: Funding for the study began in November 2018, and we are currently in the process of recruitment screening and data randomization for the study. Primary data collection will begin in May 2019 and continue through May 2021. Projected participants per site will be 76 partners/dyads, for a total of 456 study participants. Anticipated study results will be published in November 2022. Conclusions: This work highlights innovative delivery of CIH to veterans and their partners for treatment of posttraumatic stress disorder and chronic pain. Trial Registration: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 (Archived by WebCite at http://www.webcitation.org/77Q2giwtw) International Registered Report Identifier (IRRID): PRR1-10.2196/13666 %M 31094345 %R 10.2196/13666 %U http://www.researchprotocols.org/2019/5/e13666/ %U https://doi.org/10.2196/13666 %U http://www.ncbi.nlm.nih.gov/pubmed/31094345 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 4 %P e13508 %T Process Evaluation of a Medical Student–Delivered Smoking Prevention Program for Secondary Schools: Protocol for the Education Against Tobacco Cluster Randomized Trial %A Brinker,Titus Josef %A Buslaff,Fabian %A Suhre,Janina Leonie %A Silchmüller,Marc Philipp %A Divizieva,Evgenia %A Wilhelm,Jilada %A Hillebrand,Gabriel %A Penka,Dominik %A Gaim,Benedikt %A Swoboda,Susanne %A Baumermann,Sonja %A Walther,Jörg Werner %A Brieske,Christian Martin %A Jakob,Lena %A Baumert,Hannah Maria %A Anhuef,Ole %A Schmidt,Selina Marisa %A Alfitian,Jonas %A Batra,Anil %A Taha,Lava %A Mons,Ute %A Hofmann,Felix Johannes %A Haney,Ailís Ceara %A Haney,Caelán Max %A Schaible,Samuel %A Tran,Thien-An %A Beißwenger,Hanna %A Stark,Tobias %A Groneberg,David A %A Seeger,Werner %A Srivastava,Aayushi %A Gall,Henning %A Holzapfel,Julia %A Rigotti,Nancy A %A Baudson,Tanja Gabriele %A Enk,Alexander H %A Fröhling,Stefan %A von Kalle,Christof %A Bernardes-Souza,Breno %A Pereira,Rayanna Mara de Oliveira Santos %A Thomas,Roger %+ Department of Translational Oncology, National Center for Tumor Diseases, German Cancer Research Center (DKFZ), University of Heidelberg, , Heidelberg,, Germany, 49 15175084347, titus.brinker@dkfz.de %K schools %K tobacco prevention %K smoking prevention %K medical students %K medical school %D 2019 %7 11.04.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Most smokers start smoking during their early adolescence under the impression that smoking entails positive attributes. Given the addictive nature of cigarettes, however, many of them might end up as long-term smokers and suffering from tobacco-related diseases. To prevent tobacco use among adolescents, the large international medical students’ network Education Against Tobacco (EAT) educates more than 40,000 secondary school students per year in the classroom setting, using evidence-based self-developed apps and strategies. Objective: This study aimed to evaluate the long-term effectiveness of the school-based EAT intervention in reducing smoking prevalence among seventh-grade students in Germany. Additionally, we aimed to improve the intervention by drawing conclusions from our process evaluation. Methods: We conduct a cluster-randomized controlled trial with measurements at baseline and 9, 16, and 24 months postintervention via paper-and-pencil questionnaires administered by teachers. The study groups consist of randomized schools receiving the 2016 EAT curriculum and control schools with comparable baseline data (no intervention). The primary outcome is the difference of change in smoking prevalence between the intervention and control groups at the 24-month follow-up. Secondary outcomes are between-group differences of changes in smoking-related attitudes and the number of new smokers, quitters, and never-smokers. Results: A total of 11,268 students of both sexes, with an average age of 12.32 years, in seventh grade of 144 secondary schools in Germany were included at baseline. The prevalence of cigarette smoking in our sample was 2.6%. The process evaluation surveys were filled out by 324 medical student volunteers, 63 medical student supervisors, 4896 students, and 141 teachers. Conclusions: The EAT cluster randomized trial is the largest school-based tobacco-prevention study in Germany conducted to date. Its results will provide important insights with regards to the effectiveness of medical student–delivered smoking prevention programs at school. International Registered Report Identifier (IRRID): DERR1-10.2196/13508 %M 30973348 %R 10.2196/13508 %U http://www.researchprotocols.org/2019/4/e13508/ %U https://doi.org/10.2196/13508 %U http://www.ncbi.nlm.nih.gov/pubmed/30973348 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e11614 %T Using Targeted mHealth Messages to Address Hypertension and Diabetes Self-Management in Cambodia: Protocol for a Clustered Randomized Controlled Trial %A Fitzpatrick,Annette L %A van Pelt,Maurits %A Heang,Hen %A Steinman,Lesley %A Ide,Nicole %A Chhea,Chhorvann %A LoGerfo,James P %+ Department of Family Medicine, University of Washington, 4225 Roosevelt Avenue Northeast, Suite 308, Seattle, WA, 98105, United States, 1 206 685 4295, fitzpal@uw.edu %K Cambodia %K diabetes %K hypertension %K mHealth %K mobile phone %D 2019 %7 19.03.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension and diabetes represent the first and third highest contributors to global disability. While mobile health (mHealth) messaging programs have rapidly increased in low- and middle-income countries (LMIC), adaptations for specific patient health needs is a new approach to manage chronic conditions. Objective: The primary aim of this study is to develop and test an mHealth communication intervention using electronic data capture (by tablet) and voice messaging to improve hypertension and diabetes self-management in Cambodia. The secondary aim is to share results with the Cambodian Ministry of Health and development partners to inform health policy and develop strategies for hypertension and diabetes control. Methods: The study design is a cluster randomized controlled clinical trial randomizing each of 75 Community peer educators (PEs), trained and coordinated by MoPoTsyo Patient Information Center in Phnom Penh, into one of 3 groups of 25 (approximately 60 patients each) to receive either tablet+messages, tablet only, or no intervention (control). The total sample within each group includes 25 clusters and approximately 1500 patients located in 7 Operational Districts in rural regions or urban slums in Cambodia. The interventions (groups 1 and 2) were compared with usual PE monitoring without the tablet or mHealth messaging interventions. Focus groups and informant interviews were conducted to develop messages according to specific themes—medications adherence, laboratory testing, physician visits, obesity, smoking, and general lifestyle issues. Using the data received at monthly PE monitoring meetings, patients will receive specific messages based on their individual health challenges. Following the intervention completion, clinical and process outcomes will be compared with baseline metrics between groups. Results: PEs were randomized in July 2017, and the intervention was implemented in September 2017 through June 2018. Analyses are underway. Conclusions: This project is unique in its combination of electronic data transfer, which can be accessed immediately, with voice messages most relevant to individual patients’ needs. Positive results will indicate the value of using targeted messaging in patient-specific, self-management issues to improve hypertension and diabetes control. International Registered Report Identifier (IRRID): DERR1-10.2196/11614 %M 30888330 %R 10.2196/11614 %U http://www.researchprotocols.org/2019/3/e11614/ %U https://doi.org/10.2196/11614 %U http://www.ncbi.nlm.nih.gov/pubmed/30888330 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e11754 %T An Evidence-Based Health Care Knowledge Integration System: Assessment Protocol %A Nabelsi,Véronique %A Croteau,Sylvain %+ Département des sciences administratives, Université du Québec en Outaouais, Case postale 1250, Succursale Hull, Gatineau, QC, J8X 3X7, Canada, 1 8195953900 ext 1915, veronique.nabelsi@uqo.ca %K knowledge translation %K practice guideline %K community medicine %K group practice %K evidence-based medicine %K clinical decision making %K educational technology %K decision support systems, clinical %D 2019 %7 11.03.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The rapid advancements in health care can make it difficult for general physicians and specialists alike to keep their knowledge up to date. In medicine today, there are deficiencies in the application of knowledge translation (KT) in clinical practice. Some medical procedures are not required, and therefore, no value is added to the patient’s care. These unnecessary procedures increase pressures on the health care system’s resources, reduce the quality of care, and expose the patients to stress and to other potential risks. KT tools and better access to medical recommendations can lead to improvements in physicians’ decision-making processes depending on the patient’s specific clinical situation. These tools can provide the physicians with the available options and promote an efficient professional practice. Software for the Evolution of Knowledge in MEDicine (SEKMED) is a technological solution providing access to high-quality evidence, based on just-in-time principles, in the application of medical recommendations for clinical decision-making processes recognized by community members, accreditation bodies, the recommendations from medical specialty societies made available through campaigns such as Choosing Wisely, and different standards or accreditive bodies. Objective: The main objective of this protocol is to assess the usefulness of the SEKMED platform used within a real working clinical practice, specifically the Centre intégré de santé et des services sociaux de l’Outaouais in Quebec, Canada. To achieve our main objective, 20 emergency physicians from the Hull and Gatineau Hospitals participate in the project as well as 20 patient care unit physicians from the Hull Hospital. In addition, 10 external students or residents studying family medicine from McGill University will also participate in our study. Methods: The project is divided into 4 phases: (1) orientation; (2) data synthesis; (3) develop and validate the recommendations; and (4) implement, monitor, and update the recommendations. These phases will enable us to meet our 6 specific research objectives that aim to measure the integration of recommendations in clinical practices, the before and after improvements in practices, the value attributed by physicians to recommendations, the user’s platform experience, the educational benefits according to medical students, and the organizational benefits according to stakeholders. The knowledge gained during each phase will be applied on an iterative and continuous basis to all other phases over a period of 2 years. Results: This project was funded in April 2018 by the Fonds de soutien à l’innovation en santé et en services sociaux for 24 months. Ethics approval has been attained, the study began in June 2018, the data collection will be complete at the end of December 2019, and the data analysis will start in winter 2020. Both major city hospitals in the Outaouais region, Quebec, Canada, have agreed to participate in the project. Conclusions: If results show preliminary efficacy and usability of the system, a large-scale implementation will be conducted. International Registered Report Identifier (IRRID): PRR1-10.2196/11754 %M 30855235 %R 10.2196/11754 %U http://www.researchprotocols.org/2019/3/e11754/ %U https://doi.org/10.2196/11754 %U http://www.ncbi.nlm.nih.gov/pubmed/30855235 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e11707 %T Healthy Eating and Active Living for Diabetes-Glycemic Index (HEALD-GI): Protocol for a Pragmatic Randomized Controlled Trial %A Avedzi,Hayford M %A Storey,Kate %A Johnson,Jeffrey A %A Johnson,Steven T %+ Centre for Nursing and Health Studies, Faculty of Health Disciplines, Athabasca University, 1 University Drive Athabasca, Athabasca, AB, T9S 3A3, Canada, 1 877 848 6903, sjohnson@athabascau.ca %K glycemic index %K randomized controlled trial %K type 2 diabetes mellitus %D 2019 %7 06.03.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Rigorous evidence is needed regarding the best approach for increasing the uptake of Diabetes Canada’s evidence-based recommendations to include low-glycemic index (GI) foods in daily meal planning as an effective dietary self-care strategy for glycemic control among people with type 2 diabetes (T2D). Objective: This study aims to present the study design and baseline data from the Healthy Eating and Active Living for Diabetes-Glycemic Index (HEALD-GI) trial, which was designed to evaluate the effectiveness of an enhanced GI-targeted nutrition education on GI-related knowledge and mean daily GI among adults with T2D in Edmonton, Alberta. Methods: We used a pragmatic randomized controlled trial design and allocated 67 adults (aged ≥18 years) with T2D living in Edmonton, Alberta, Canada, to a control group that received standard printed copies of Canada’s Food Guide and Diabetes Canada’s GI resources or to an intervention group that received the same materials, plus a customized Web-based platform with 6 self-directed learning modules and print material. Each module included videos, links to reliable websites, chat rooms, and quizzes. Evidence-based GI concept information included GI values of foods and low-GI shopping, recipes, and cooking tips by a registered dietitian. In addition, support through email, text messaging (short message service), phone calls, or postal mail was provided to reinforce participants’ learning. The primary outcome, average dietary GI, was assessed using 3-day food records. Additional measures including GI knowledge and self-efficacy, glycated hemoglobin (HbA1c), lipids, systolic blood pressure, body mass index (BMI; weight, height), waist circumference, and computer proficiency were assessed at baseline and at 3-month postintervention. Results: Between November 2017 and February 2018, we contacted adults (aged ≥18 years) with T2D living in Edmonton, Alberta, screened and recruited eligible participants into the study. All data collection ended in June 2018. Overall, 64% (43/67) participants were males; mean age was 69.5 (SD 9.3) years, with a mean diabetes duration of 19.0 (SD 13.7) years. Mean BMI was 30.1 (SD 5.7) kg/m2, and mean HbA1c value was 7.1% (SD 1.2%). Data analysis was completed in December 2018. Conclusions: The GI concept is often difficult to teach. The HEALD-GI study aims to provide evidence in support of an alternative approach to translating the GI concept to adults with T2D. Findings from this study may help registered dietitians to better disseminate low-GI dietary recommendations using efficient and cost-effective, patient-centered approaches. Furthermore, evidence generated will contribute to addressing some of the controversies regarding the clinical usefulness of the GI concept. International Registered Report Identifier (IRRID): DERR1-10.2196/11707 %M 30839283 %R 10.2196/11707 %U https://www.researchprotocols.org/2019/3/e11707/ %U https://doi.org/10.2196/11707 %U http://www.ncbi.nlm.nih.gov/pubmed/30839283 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e13011 %T A Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Protocol for a Randomized Controlled Trial %A Henriksson,Pontus %A Sandborg,Johanna %A Blomberg,Marie %A Alexandrou,Christina %A Maddison,Ralph %A Silfvernagel,Kristin %A Henriksson,Hanna %A Leppänen,Marja H %A Migueles,Jairo H %A Widman,Linnea %A Thomas,Kristin %A Trolle Lagerros,Ylva %A Löf,Marie %+ Department of Biosciences and Nutrition, Karolinska Institutet, Group/MLÖ, SE-141 83 Huddinge, Sweden, Huddinge,, Sweden, 46 701749556, pontus.henriksson@ki.se %K telemedicine %K pregnancy %K gestational weight gain %K diet %K exercise %K smartphone %K mobile phone %D 2019 %7 01.03.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Excessive gestational weight gain is common and associated with adverse outcomes both in the short and long term. Although traditional lifestyle-based interventions have shown to mitigate excess gestational weight gain, little is known about whether mobile Health (mHealth) apps can promote healthy weight gain, diet, and physical activity during pregnancy. Objective: The primary aim of the HealthyMoms trial is to determine the effectiveness of a smartphone app (HealthyMoms) for mitigating excess gestational weight gain during pregnancy. Secondary aims are to determine the effectiveness of the app on dietary habits, physical activity, body fatness, and glycemia during pregnancy. Methods: HealthyMoms is a two-arm randomized controlled trial. Women are being recruited at routine visits at the maternity clinics in Linköping, Norrköping and Motala, Sweden. Women are randomized to the control or intervention group (n=150 per group). All women will receive standard care, and women in the intervention group will also receive the HealthyMoms smartphone app. Results: Recruitment of participants to the trial was initiated in October 2017, and 190 women have so far completed the baseline measurement. The baseline measures are estimated to be finalized in December 2019, and the follow-up measures are estimated to be completed in June 2020. Conclusions: This project will evaluate a novel smartphone app intervention integrated with existing maternity health care. If successful, it has great potential to be implemented nationally in order to promote healthy weight gain and health behaviors during pregnancy. International Registered Report Identifier (IRRID): DERR1-10.2196/13011 %M 30821695 %R 10.2196/13011 %U http://www.researchprotocols.org/2019/3/e13011/ %U https://doi.org/10.2196/13011 %U http://www.ncbi.nlm.nih.gov/pubmed/30821695 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 2 %P e11002 %T Examining the Effects of Mindful Eating Training on Adherence to a Carbohydrate-Restricted Diet in Patients With Type 2 Diabetes (the DELISH Study): Protocol for a Randomized Controlled Trial %A Mason,Ashley E %A Saslow,Laura %A Moran,Patricia J %A Kim,Sarah %A Wali,Priyanka K %A Abousleiman,Hiba %A Hartman,Alison %A Richler,Robert %A Schleicher,Samantha %A Hartogensis,Wendy %A Epel,Elissa S %A Hecht,Frederick %+ UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, 1545 Divisadero Street, 4th Floor, San Francisco, CA, 94115, United States, 1 4155146820, Ashley.Mason@ucsf.edu %K treatment adherence and compliance %K mind-body therapies %K diabetes mellitus %K diet, ketogenic %K mindfulness %D 2019 %7 20.02.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diet patterns have a profound influence on glycemic control for individuals with type 2 diabetes mellitus (T2DM), and craving-related eating is an important obstacle to dietary adherence. A growing body of research suggests that carbohydrate-restricted (CR) diets can improve glycemic control and reduce medication dependence in T2DM. However, limited data speak to the effects of long-term adherence to CR diets. Mindful eating training has been shown to reduce craving-related eating in overweight populations but has yet to be examined as a behavioral support for dietary adherence in T2DM. This trial examines behavioral mechanisms, particularly craving-related eating, through which mindful eating training might improve adherence to CR dietary recommendations in T2DM. This will clarify the importance of focusing on craving-related eating in the optimization of dietary adherence interventions. Objective: The aim of this trial is to determine whether providing training in mindful eating increases adherence to a CR dietary recommendation in T2DM. Methods: We are randomizing 60 participants to receive a CR diet with or without mindful eating training (12-week group intervention) and are following participants for 12 weeks after intervention completion. We hypothesize that participants who receive mindful eating training (relative to those who do not) will demonstrate greater adherence to the CR diet. Results: Our primary outcome is change in craving-related eating, as assessed using an ecological momentary assessment mobile phone–based platform. Secondary behavioral pathway outcomes include changes in stress-related eating, impulsivity, glycemic control, weight change, dietary adherence, and resumption of dietary adherence after dietary nonadherence. Conclusions: This theory-driven trial will shed light on the impact of mindfulness training on mechanisms that may impact dietary adherence in T2DM. Trial Registration: ClinicalTrials.gov NCT03207711; https://clinicaltrials.gov/ct2/show/NCT03207711 (Archived by WebCite at http://www.webcitation.org/73pXscwaU)  %M 30545813 %R 10.2196/11002 %U http://www.researchprotocols.org/2019/2/e11002/ %U https://doi.org/10.2196/11002 %U http://www.ncbi.nlm.nih.gov/pubmed/30545813 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 2 %P e11827 %T Development of a Web-Based Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals Living in the Community: Protocol for a Pilot Randomized Controlled Trial %A Wasilewski,Marina B %A Nonoyama,Mika %A Dale,Craig %A McKim,Douglas A %A Road,Jeremy %A Leasa,David %A Goldstein,Roger %A Rose,Louise %+ Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Suite 276, 155 College Street, Toronto, ON, M5T 1P8, Canada, 1 4166668732, marina.bastawrous@utoronto.ca %K intervention %K caregivers %K peer support %K mechanical ventilation %D 2019 %7 06.02.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Across Europe, Canada, Australia, and the United States, the prevalence of home mechanical ventilation (HMV) prevalence is 6.6-12.9 per 100,000. At-home ventilator-assisted individuals (VAIs) are often vulnerable and highly comorbid, requiring complex care. In Canada, most VAI care is provided by family, leading to poor health-related quality of life and increased caregiver burden. No supportive interventions or peer support programs are tailored to VAI caregivers. Owing to the financial, geographic, and time limitations, Web-based support delivery may especially meet VAI family caregiver needs. We have developed a peer mentor training and Web-based peer support program for VAI caregivers including information-sharing, peer-to-peer communication, and peer mentorship. Objective: Study Stage 1 aims to (1) evaluate the face and content validity of the peer mentor training program and (2) investigate participant satisfaction. Study Stage 2 aims to evaluate (1) the feasibility of participant recruitment and Web-based program delivery; (2) acceptability, usability, and satisfactoriness; (3) experiences of caregivers and peer mentors with the Web-based peer support program; and (4) effect of the Web-based peer support program on caregiver health outcomes. Methods: Study Stage 1: We will train 7 caregivers to act as peer mentors for the Web-based peer support program trial; they will complete questionnaires rating the utility of individual training sessions and the training program overall. Study Stage 2: We will recruit 30 caregiver peers for a pilot randomized controlled trial of the 12-week Web-based peer support program using a waitlist control; the program includes private chat, a public discussion forum, and weekly moderated chats. Caregiver peers will be randomized to the intervention or waitlist control group using a 1:1 ratio using Randomize.net. Both groups will complete pre- and postintervention health outcome questionnaires (ie, caregiving impact, mastery, coping, personal gain, positive affect, and depression). Caregiver peers in the intervention arm will only complete a program evaluation and will be invited to participate in an interview to provide insight into their experience. Peer mentors will be invited to participate in a Web-based focus group to provide insight into their experience as mentors. We will judge the feasibility per the number of recruitment and program delivery goals met, use analysis of covariance to compare health outcomes between intervention and control groups, and analyze qualitative data thematically. Results: Peer mentor training was completed with 5 caregivers in July 2018. To date, 2 caregivers have beta-tested the website, and the Web-based peer support program trial will commence in September 2018. Results are expected by early 2019. Conclusions: This study will result in the production and initial evaluation of a rigorously developed, evidence- and stakeholder-informed Web-based peer training and peer support program for caregivers of VAIs residing at home. International Registered Report Identifier (IRRID): PRR1-10.2196/11827 %M 30724737 %R 10.2196/11827 %U http://www.researchprotocols.org/2019/2/e11827/ %U https://doi.org/10.2196/11827 %U http://www.ncbi.nlm.nih.gov/pubmed/30724737 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12601 %T Improving Blood Pressure Among African Americans With Hypertension Using a Mobile Health Approach (the MI-BP App): Protocol for a Randomized Controlled Trial %A Buis,Lorraine R %A Dawood,Katee %A Kadri,Reema %A Dawood,Rachelle %A Richardson,Caroline R %A Djuric,Zora %A Sen,Ananda %A Plegue,Melissa %A Hutton,David %A Brody,Aaron %A McNaughton,Candace D %A Brook,Robert D %A Levy,Phillip %+ Department of Family Medicine, University of Michigan, 1018 Fuller Street, Ann Arbor, MI, 48104, United States, 1 734 998 7120, buisl@umich.edu %K hypertension %K mHealth %K blood pressure %K smartphone %K mobile phone %D 2019 %7 25.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: African Americans shoulder significant disparities related to hypertension (HTN), which is a serious public health problem in the city of Detroit, Michigan, where more than 80% of the population is African American. Connectivity through smartphones, use of home blood pressure (BP) monitoring, and newly developed mobile health (mHealth) interventions can facilitate behavioral changes and may improve long-term self-care for chronic conditions, but implementation of a combined approach utilizing these methods has not been tested among African American patients with uncontrolled HTN. Since African Americans are more likely than other racial or ethnic subgroups to utilize the emergency department (ED) for ambulatory care, this presents an opportunity to intervene on a population that is otherwise difficult to reach. Objective: The MI-BP app aims to reduce health disparities related to HTN in the community by employing a user-centered intervention focused on self-BP monitoring, physical activity, reduced sodium intake, and medication adherence. We seek to test the efficacy of MI-BP, an mHealth app for HTN self-management, on BP control (primary aim), physical activity, sodium intake, and medication adherence (secondary aim) in African Americans with HTN. This study also seeks to evaluate the cost-effectiveness of MI-BP when compared with usual care methods. Methods: This is a 1-year randomized controlled trial that will recruit individuals who have uncontrolled HTN from 2 EDs in the city of Detroit, with a planned sample size of 396 randomized participants. To be eligible for inclusion, potential participants must be African American, 25 to 70 years old, previously diagnosed with HTN, have a smartphone compatible with MI-BP, and have uncontrolled BP at triage and on repeat measurement at least 1-hour post triage vitals. Once a participant is deemed eligible, all study procedures and subsequent follow-up visits (8 in total) are conducted at the Wayne State University Clinical Research Service Center. We seek to determine the effect of MI-BP on BP for 1 year (using BP control and mean systolic BP as coprimary outcomes and physical activity, sodium intake, and medication adherence as secondary outcomes) compared with usual care controls. Results: Recruitment for this study began in January 2018. The study will continue through 2021. Conclusions: As the first of its kind conducted in an ED setting, MI-BP was designed to document the efficacy and acceptability of a multicomponent mHealth approach to help African Americans with uncontrolled BP modify their lifestyle to better manage their HTN. We expect to lay the foundation to sustainably reduce HTN-related health disparities through better integration of multiple behavior self-monitoring and improve outcomes for those who traditionally rely on the ED for chronic disease care. Trial Registration: ClinicalTrials.gov NCT02360293; http://clinicaltrials.gov/ct2/show/NCT02360293 International Registered Report Identifier (IRRID): RR1-10.2196/12601 %M 30681965 %R 10.2196/12601 %U http://www.researchprotocols.org/2019/1/e12601/ %U https://doi.org/10.2196/12601 %U http://www.ncbi.nlm.nih.gov/pubmed/30681965 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10238 %T Collecting Symptoms and Sensor Data With Consumer Smartwatches (the Knee OsteoArthritis, Linking Activity and Pain Study): Protocol for a Longitudinal, Observational Feasibility Study %A Beukenhorst,Anna L %A Parkes,Matthew J %A Cook,Louise %A Barnard,Rebecca %A van der Veer,Sabine N %A Little,Max A %A Howells,Kelly %A Sanders,Caroline %A Sergeant,Jamie C %A O'Neill,Terence W %A McBeth,John %A Dixon,William G %+ Arthritis Research United Kingdom Centre for Epidemiology, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre, Oxford Rd, Manchester, M13 9PT, United Kingdom, 44 0 161 275 1642, Will.Dixon@manchester.ac.uk %K medical informatics computing %K mHealth %K patient-reported outcomes %K musculoskeletal diseases %K mobile phone %D 2019 %7 23.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The Knee OsteoArthritis, Linking Activity and Pain (KOALAP) study is the first to test the feasibility of using consumer-grade cellular smartwatches for health care research. Objective: The overall aim was to investigate the feasibility of using consumer-grade cellular smartwatches as a novel tool to capture data on pain (multiple times a day) and physical activity (continuously) in patients with knee osteoarthritis. Additionally, KOALAP aimed to investigate smartwatch sensor data quality and assess whether engagement, acceptability, and user experience are sufficient for future large-scale observational and interventional studies. Methods: A total of 26 participants with self-diagnosed knee osteoarthritis were recruited in September 2017. All participants were aged 50 years or over and either lived in or were willing to travel to the Greater Manchester area. Participants received a smartwatch (Huawei Watch 2) with a bespoke app that collected patient-reported outcomes via questionnaires and continuous watch sensor data. All data were collected daily for 90 days. Additional data were collected through interviews (at baseline and follow-up) and baseline and end-of-study questionnaires. This study underwent full review by the University of Manchester Research Ethics Committee (#0165) and University Information Governance (#IGRR000060). For qualitative data analysis, a system-level security policy was developed in collaboration with the University Information Governance Office. Additionally, the project underwent an internal review process at Google, including separate reviews of accessibility, product engineering, privacy, security, legal, and protection regulation compliance. Results: Participants were recruited in September 2017. Data collection via the watches was completed in January 2018. Collection of qualitative data through patient interviews is still ongoing. Data analysis will commence when all data are collected; results are expected in 2019. Conclusions: KOALAP is the first health study to use consumer cellular smartwatches to collect self-reported symptoms alongside sensor data for musculoskeletal disorders. The results of this study will be used to inform the design of future mobile health studies. Results for feasibility and participant motivations will inform future researchers whether or under which conditions cellular smartwatches are a useful tool to collect patient-reported outcomes alongside passively measured patient behavior. The exploration of associations between self-reported symptoms at different moments will contribute to our understanding of whether it may be valuable to collect symptom data more frequently. Sensor data–quality measurements will indicate whether cellular smartwatch usage is feasible for obtaining sensor data. Methods for data-quality assessment and data-processing methods may be reusable, although generalizability to other clinical areas should be further investigated. International Registered Report Identifier (IRRID): DERR1-10.2196/10238 %M 30672745 %R 10.2196/10238 %U http://www.researchprotocols.org/2019/1/e10238/ %U https://doi.org/10.2196/10238 %U http://www.ncbi.nlm.nih.gov/pubmed/30672745 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11549 %T Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a Pragmatic Randomized Controlled Trial %A Sawyer,Alyssa CP %A Kaim,Amy L %A Reece,Christy E %A McDonald,Denise %A Le,Huynh-Nhu %A Clark,Jennifer %A Lynch,John W %A Sawyer,Michael G %+ School of Public Health, University of Adelaide, Adelaide Health & Medical Sciences Building, 57 North Terrace, Mail Drop DX 650 550, Adelaide, 5005, Australia, 61 8 8161 7207, alyssa.sawyer@adelaide.edu.au %K app %K infant %K mobile phone %K mother-child relations %K mother-child nursing %K postnatal depression %K protocol %K randomized controlled trial %D 2019 %7 16.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Postnatal depression adversely affects many mothers and infants with good evidence that caregiving difficulties associated with depressive symptoms play a key role in later adverse childhood outcomes. In many countries, there is only limited support available for women who experience symptoms of depression during the postnatal period, particularly those experiencing subthreshold symptom levels. Furthermore, mental health services and community family health services in many countries tend to focus primarily on providing help for depressive symptoms or maternal caregiving, respectively, despite these problems commonly being comorbid. Group-based nurse-led interventions delivered over the Web through mobile phone “apps” have the potential to be a cost-effective method of providing a large number of mothers with easy access to integrated support for both maternal depressive symptoms and caregiving difficulties. Objective: This paper describes the protocol for a pragmatic randomized controlled trial of a 4-month group-based nurse-led intervention delivered over the Web when infants were 2-6 months. The primary aims of the trial are to determine whether the intervention (1) reduces levels of maternal depressive symptoms and (2) improves the quality of maternal caregiving when infants are 8-12 months of age. Methods: The trial aimed to recruit and randomize 160 mothers of infants aged 2-8 weeks to either the intervention (eMums plus) or standard care. Assessments were completed when infants were aged 1-2 (preintervention), 8, and 12 months. The primary outcomes were the level of maternal depressive symptoms and the quality of maternal caregiving assessed when infants were aged 12 months. The intervention provided specific support for problems with mood and problems with caregiving. The intervention was delivered by community health nurses as a part of routine service delivery to mothers via a mobile phone app. Results: Participant recruitment was carried out from March to July 2017. Follow-up data collection was completed in mid-2018. Data analysis has commenced. Conclusions: In the past, many mothers participated in nurse-led face-to-face groups postnatally. However, mothers’ groups held in clinics can be difficult for busy mothers to attend. The eMums intervention was delivered over the Web by nurses, allowing easy access by mothers early in an infant’s life. The intervention was evaluated while delivered as part of the routine service practice by community child health nurses. The advantage of evaluating the effectiveness of the intervention in the routine service practice is that if it is found to be effective, it can be more easily adopted by the service provider than if it had been assessed in an efficacy trial. International Registered Report Identifier (IRRID): RR1-10.2196/11549 %M 30664487 %R 10.2196/11549 %U http://www.researchprotocols.org/2019/1/e11549/ %U https://doi.org/10.2196/11549 %U http://www.ncbi.nlm.nih.gov/pubmed/30664487 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10938 %T Effect of a Mobile App on Preoperative Patient Preparation for Major Ambulatory Surgery: Protocol for a Randomized Controlled Trial %A Herrera-Usagre,Manuel %A Santana,Vicente %A Burgos-Pol,Ramon %A Oliva,Juan Pedro %A Sabater,Eliazar %A Rita-Acosta,Maria %A Casado,Miguel Angel %A Cruces,Susana %A Pacheco,Manuel %A Solorzano Perez,Carlos %+ Andalusian Agency for Healthcare Quality, Science and Technology Park, Italian Pavillion, 3rd Floor, 4 Isaac Newton Street, Sevilla, 41092, Spain, 34 645539726, manuel.herrera.usagre@juntadeandalucia.es %K ambulatory surgical procedures %K cost-benefit analysis %K mobile phone %K patient compliance %K patient safety %K preoperative care %K telemedicine %D 2019 %7 16.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Inadequate preoperative patient preparation causes organizational, economic, and emotional problems to patients and professionals. In Spain, no current evidence is available on either the rate of compliance or the impact of good compliance with preoperative recommendations by patients in the ambulatory setting. However, it is known that around 25% of surgical cancellations in the major ambulatory surgery (MAS) are due to poor compliance with these recommendations and, therefore, avoidable. Introducing innovative tools based on mobile health (mHealth) apps may help patients meet the preoperative recommendations and, consequently, reduce the rate of cancellations in the ambulatory setting. Objective: The objective of this study was to evaluate the effectiveness of the Listeo+ mHealth app as a tool for improving compliance with preoperative recommendations in MAS versus standard of care (SOC). Methods: A multicenter, randomized, open-label clinical trial that compares SOC with the additional use of Listeo+, a specific mHealth app for MAS preoperative patient monitoring, is being conducted. The study will include patients aged ≥18 years with surgical indication for MAS who meet the necessary technological and connectivity requirements. Patients in the control group will receive written preoperative recommendations, while those in the intervention group will additionally use the Listeo+ mHealth app. There will be a competitive recruitment of 790 patients during 6 months in 4 hospitals in Andalusia (Spain) that belong to the National Health System. The primary efficacy outcome is the level of compliance with preoperative recommendations. Secondary outcomes include the rate of cancellations, associated resource consumption, and perceived usability and utility with Listeo+ by participants of the intervention group. Simple randomization 1:1 procedure will be used to allocate patients to each study group. Results: The technological development of Listeo+ and the integration and interoperability of information systems was completed in September 2017. Subsequently, simulation tests were performed with Listeo+, and a pilot study was initiated with real patients that concluded successfully in October 2017. Patient recruitment began in December 2017 in the 4 participating centers. After an intermediate analysis performed 10 months after the start of the recruitment phase, the data collection and cleaning phases are estimated to be completed in April 2019, and the analysis with the final results will be conducted in July 2019. Conclusions: Progress in the integration and interoperability of information systems represents a major step forward in the field of mHealth. The app will allow health professionals to monitor in real-time patients’ preparation and critical preoperative recommendations fulfillment. We expect a reduction in avoidable preoperative cancellations due to a lack of or a poor patient preparation. Self-assessed Web-based questionnaires and focus group will provide important information about the perceived usability and utility of Listeo+ app among patients and health care professionals. International Registered Report Identifier (IRRID): DERR1-10.2196/10938 %M 30664480 %R 10.2196/10938 %U http://www.researchprotocols.org/2019/1/e10938/ %U https://doi.org/10.2196/10938 %U http://www.ncbi.nlm.nih.gov/pubmed/30664480 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11000 %T The Impact of the mKidney mHealth System on Live Donor Follow-Up Compliance: Protocol for a Randomized Controlled Trial %A Henderson,Macey L %A Thomas,Alvin G %A Eno,Ann K %A Waldram,Madeleine M %A Bannon,Jaclyn %A Massie,Allan B %A Levan,Michael A %A Segev,Dorry L %A Bingaman,Adam W %+ Department of Surgery, Johns Hopkins University School of Medicine, 2000 East Monument Street, Baltimore, MD, 21205, United States, 1 443 287 6649, macey@jhmi.edu %K app %K follow-up %K health care %K kidney transplantation %K mHealth %K mobile phone %K randomized controlled trial %K protocol %D 2019 %7 15.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Every year, more than 5500 healthy people in the United States donate a kidney for the medical benefit of another person. The Organ Procurement and Transplantation Network (OPTN) requires transplant hospitals to monitor living kidney donors (LKDs) for 2 years postdonation. However, the majority (115/202, 57%) of transplant hospitals in the United States continue to fail to meet nationally mandated requirements for LKD follow-up. A novel method for collecting LKD follow-up is needed to ease both the transplant hospital-level and patient-level burden. We built mKidney—a mobile health (mHealth) system designed specifically to facilitate the collection and reporting of OPTN-required LKD follow-up data. The mKidney mobile app was developed on the basis of input elicited from LKDs, transplant providers, and thought leaders. Objective: The primary objective of this study is to evaluate the impact of the mKidney smartphone app on LKD follow-up rates. Methods: We will conduct a two-arm randomized controlled trial (RCT) with LKDs who undergo LKD transplantation at Methodist Specialty and Transplant Hospital in San Antonio, Texas. Eligible participants will be recruited in-person by a study team member at their 1-week postdonation clinical visit and randomly assigned to the intervention or control arm (1:1). Participants in the intervention arm will receive the mHealth intervention (mKidney), and participants in the control arm will receive the current standard of follow-up care. Our primary outcome will be policy-defined complete (all components addressed) and timely (60 days before or after the expected visit date) submission of LKD follow-up data at required 6-month, 1-year, and 2-year visits. Our secondary outcome will be hospital-level compliance with OPTN reporting requirements at each visit. Data analysis will follow the intention-to-treat principle. Additionally, we will collect quantitative and qualitative process data regarding the implementation of the mKidney system. Results: We began recruitment for this RCT in May 2018. We plan to enroll 400 LKDs over 2 years and follow participants for the 2-year mandated follow-up period. Conclusions: This pilot RCT will evaluate the impact of the mKidney system on rates of LKD and hospital compliance with OPTN-mandated LKD follow-up at a large LKD transplant hospital. It will provide valuable information on strategies for implementing such a system in a clinical setting and inform effect sizes for future RCT sample size calculations. International Registered Report Identifier (IRRID): DERR1-10.2196/11000 %M 30664485 %R 10.2196/11000 %U http://www.researchprotocols.org/2019/1/e11000/ %U https://doi.org/10.2196/11000 %U http://www.ncbi.nlm.nih.gov/pubmed/30664485 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12322 %T Delivery of Peer Support Through a Self-Management mHealth Intervention (Healing Circles) in Patients With Cardiovascular Disease: Protocol for a Randomized Controlled Trial %A Sakakibara,Brodie M %A Chakrabarti,Santabhanu %A Krahn,Andrew %A Mackay,Martha H %A Sedlak,Tara %A Singer,Joel %A Whitehurst,David GT %A Lear,Scott A %+ Faculty of Health Sciences, Simon Fraser University, 180-1081 Burrard Street, Vancouver, BC,, Canada, 1 604 682 2344 ext 62778, slear@providencehealth.bc.ca %K cardiovascular disease %K eHealth %K mhealth %K mobile phone %K peer support %K self-management %D 2019 %7 11.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cardiovascular disease (CVD) is a leading cause of hospitalization and death around the world. The prevalence of CVD is increasing and, therefore, development and investigation of effective programs to help people better self-manage their CVD and prevent secondary complications are needed. Objective: In this paper, we report on a protocol to evaluate Healing Circles—an evidence-based and patient-informed peer support mobile health program designed to facilitate self-management and support patients in their recovery from and management of CVD. We hypothesize that individuals with CVD who use Healing Circles will experience greater improvements to their self-management ability than individuals receiving usual care. Methods: In this single-blinded (assessor) randomized controlled trial, 250 community-living individuals with CVD will be randomized on a 1:1 basis to either Healing Circles or Usual Care. The primary outcome of self-management will be measured using the Health Education Impact Questionnaire version 3.0. Secondary outcomes include self-efficacy with chronic disease management, health-related quality of life, health resource use and costs, and electronic health literacy. Measurements will be taken at the baseline and every 6 months for 24 months. Results: The study started recruitment in September 2017. Individuals are currently being recruited for participation, and existing participants are currently on follow-up. Measurements will be taken every 6 months until the study end, which is anticipated in December 2019. Conclusions: Healing Circles is a novel program aimed toward improving self-management through peer support. Given our real-world study design, our findings will be readily translatable into practice. If the results support our hypothesis, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use. Trial Registration: ClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd) International Registered Report Identifier (IRRID): DERR1-10.2196/12322 %M 30635261 %R 10.2196/12322 %U http://www.researchprotocols.org/2019/1/e12322/ %U https://doi.org/10.2196/12322 %U http://www.ncbi.nlm.nih.gov/pubmed/30635261 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 12 %P e11282 %T A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial (LowSalt4Life Trial) %A Dorsch,Michael P %A An,Lawrence C %A Hummel,Scott L %+ Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI, 48109, United States, 1 734 647 1452, mdorsch@med.umich.edu %K geofencing %K hypertension %K mobile phone %K sodium intake %D 2018 %7 07.12.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: High sodium intake is a significant public health problem in the United States. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average US diet coming from processed and restaurant foods. Objective: This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low-sodium diet in hypertension. Methods: In this single-center, prospective, open-label study, patients will be randomized to a mobile app or usual care for 8 weeks. We will randomize 50 patients (age>18 years) diagnosed with hypertension and on antihypertensive therapy for at least 3 months in a 1:1 manner stratified by gender. Study subjects will receive the mobile app, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint is the change in the estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include change in the sodium content of the food frequency questionnaire, confidence in following a low-sodium diet, urine chloride and creatinine dipsticks, and blood pressure. Results: The project was funded in May 2016 until April 2018. This trial is currently enrolling patients. To date, 26 of the 50 patients needed have been enrolled. Results will be available in the Spring of 2019. Conclusions: This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages through a novel mobile app 8-week intervention on urinary sodium excretion in patients with hypertension. We will address a critical evidence gap in the care of patients with hypertension. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in hypertension. Trial Registration: ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 (Archived by WebCite at http://www.webcitation.org/735HNzKlQ) International Registered Report Identifier (IRRID): PRR1-10.2196/11282 %M 30530462 %R 10.2196/11282 %U https://www.researchprotocols.org/2018/12/e11282/ %U https://doi.org/10.2196/11282 %U http://www.ncbi.nlm.nih.gov/pubmed/30530462 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 12 %P e12464 %T Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial %A Jódar-Sánchez,Francisco %A Carrasco Hernández,Laura %A Núñez-Benjumea,Francisco J %A Mesa González,Marco Antonio %A Moreno Conde,Jesús %A Parra Calderón,Carlos Luis %A Fernandez-Luque,Luis %A Hors-Fraile,Santiago %A Civit,Anton %A Bamidis,Panagiotis %A Ortega-Ruiz,Francisco %+ Research and Innovation Group in Biomedical Informatics, Biomedical Engineering and Health Economy, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital / Spanish National Research Council / University of Seville, Avenida Manuel Siurot, s/n, Centro de Documentación Clínica Avanzada, Virgen del Rocío University Hospital, Seville, 41013, Spain, 34 955013616, francisco.nunez.exts@juntadeandalucia.es %K smoking cessation %K mobile applications %K randomized controlled trial %K economic evaluation %D 2018 %7 06.12.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Smoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt. Objective: We present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group). Methods: The target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits. Results: Of 548 patients identified using the hospital’s electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019. Conclusions: Social networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking. Trial Registration: ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/record/NCT03553173 (Archived by WebCite at http://www.webcitation.org/74DuHypOW). International Registered Report Identifier (IRRID): PRR1-10.2196/12464 %M 30522992 %R 10.2196/12464 %U http://www.researchprotocols.org/2018/12/e12464/ %U https://doi.org/10.2196/12464 %U http://www.ncbi.nlm.nih.gov/pubmed/30522992 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 12 %P e12339 %T Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial) %A Mizuno,Katsuhiro %A Abe,Takayuki %A Ushiba,Junichi %A Kawakami,Michiyuki %A Ohwa,Tomomi %A Hagimura,Kazuto %A Ogura,Miho %A Okuyama,Kohei %A Fujiwara,Toshiyuki %A Liu,Meigen %+ Department of Rehabilitation Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjukukku, Tokyo, 160-8582, Japan, 81 3 5363 3833 ext 62264, mizuno.katsuhiro@gmail.com %K brain-computer interfaces %K neurofeedback %K neural plasticity %K electroencephalography %K hemiplegia %K electric stimulation %K robotics %D 2018 %7 06.12.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: We developed a brain-machine interface (BMI) system for poststroke patients with severe hemiplegia to detect event-related desynchronization (ERD) on scalp electroencephalogram (EEG) and to operate a motor-driven hand orthosis combined with neuromuscular electrical stimulation. ERD arises when the excitability of the ipsi-lesional sensorimotor cortex increases. Objective: The aim of this study was to evaluate our hypothesis that motor training using this BMI system could improve severe hemiparesis that is resistant to improvement by conventional rehabilitation. We, therefore, planned and implemented a randomized controlled clinical trial (RCT) to evaluate the effectiveness and safety of intensive rehabilitation using the BMI system. Methods: We conducted a single blind, multicenter RCT and recruited chronic poststroke patients with severe hemiparesis more than 90 days after onset (N=40). Participants were randomly allocated to the BMI group (n=20) or the control group (n=20). Patients in the BMI group repeated 10-second motor attempts to operate EEG-BMI 40 min every day followed by 40 min of conventional occupational therapy. The interventions were repeated 10 times in 2 weeks. Control participants performed a simple motor imagery without servo-action of the orthosis, and electrostimulation was given for 10 seconds for 40 min, similar to the BMI intervention. Overall, 40 min of conventional occupational therapy was also given every day after the control intervention, which was also repeated 10 times in 2 weeks. Motor functions and electrophysiological phenotypes of the paretic hands were characterized before (baseline), immediately after (post), and 4 weeks after (follow-up) the intervention. Improvement in the upper extremity score of the Fugl-Meyer assessment between baseline and follow-up was the main outcome of this study. Results: Recruitment started in March 2017 and ended in July 2018. This trial is currently in the data correcting phase. This RCT is expected to be completed by October 31, 2018. Conclusions: No widely accepted intervention has been established to improve finger function of chronic poststroke patients with severe hemiparesis. The results of this study will provide clinical data for regulatory approval and novel, important understanding of the role of sensory-motor feedback based on BMI to induce neural plasticity and motor recovery. Trial Registration: UMIN Clinical Trials Registry UMIN000026372; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000030299 (Archived by WebCite at http://www.webcitation.org/743zBJj3D) International Registered Report Identifier (IRRID): DERR1-10.2196/12339 %M 30522993 %R 10.2196/12339 %U http://www.researchprotocols.org/2018/12/e12339/ %U https://doi.org/10.2196/12339 %U http://www.ncbi.nlm.nih.gov/pubmed/30522993 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 11 %P e11069 %T Improving Self-Management Skills Among People With Spinal Cord Injury: Protocol for a Mixed-Methods Study %A Mortenson,W Ben %A Mills,Patricia Branco %A Adams,Jared %A Singh,Gurkaran %A MacGillivray,Megan %A Sawatzky,Bonita %+ Department of Occupational Sciences and Occupational Therapy, Faculty of Medicine, University of British Columbia, T325, 2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada, 1 604 822 7392, ben.mortenson@ubc.ca %K self-management %K spinal cord injury %K eHealth %K mHealth %D 2018 %7 14.11.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Most people with spinal cord injury will develop secondary complications with potentially devastating consequences. Self-management is a key prevention strategy for averting the development of secondary complications and their recurrence. Several studies have shown that self-management programs improve self-management behaviors and health outcomes in individuals living with chronic conditions such as asthma, diabetes, hypertension, and arthritis. Given the burgeoning health care costs related to secondary complications, we developed an alternative electronic health–based implementation to facilitate the development of self-management skills among people with spinal cord injury. Objective: This study aims to evaluate the efficacy of a self-management app in spinal cord injury populations. The primary outcome is attainment of self-selected, self-management goals. Secondary outcomes include increases in general and self-management self-efficacy and reductions in self-reported health events, health care utilization, and secondary complications related to spinal cord injury. This study also aims to explore how the intervention was implemented and how the app was experienced by end users. Methods: This study will employ a mix of qualitative and quantitative methods. The quantitative portion of our study will involve a rater-blinded, randomized controlled trial with a stepped wedge design (ie, delayed intervention control group). The primary outcome is successful goal attainment, and secondary outcomes include increases in self-efficacy and reductions in self-reported health events, health care utilization, and secondary conditions related to spinal cord injury. The qualitative portion will consist of semistructured interviews with a subsample of the participants. Results: We expect that the mobile self-management app will help people with spinal cord injury to attain their self-management goals, improve their self-efficacy, reduce secondary complications, and decrease health care utilization. Conclusions: If the results are positive, this study will produce credible new knowledge describing multiple outcomes that people with spinal cord injury realize from an app-based self-management intervention and support its implementation in clinical practice. Trial Registration: ClinicalTrials.gov NCT03140501; http://clinicaltrials.gov/ct2/show/NCT03140501 (Archived by WebCite at http://www.webcitation.org/73Gw0ZlWZ) International Registered Report Identifier (IRRID): PRR1-10.2196/11069 %M 30429114 %R 10.2196/11069 %U http://www.researchprotocols.org/2018/11/e11069/ %U https://doi.org/10.2196/11069 %U http://www.ncbi.nlm.nih.gov/pubmed/30429114 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 11 %P e11289 %T The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the Primary Prevention of Cardiovascular Disease: Protocol for a Randomized Controlled Trial %A Byrne,Jo L %A Dallosso,Helen M %A Rogers,Stephen %A Gray,Laura J %A Waheed,Ghazala %A Patel,Prashanth %A Gupta,Pankaj %A Doherty,Yvonne %A Davies,Melanie %A Khunti,Kamlesh %+ Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, LE5 4PW, United Kingdom, 44 116 258 4005, kk22@leicester.ac.uk %K medication adherence %K cardiovascular diseases %K primary prevention %K educational intervention %K telephone support %K text messaging support %D 2018 %7 12.11.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease is lacking. The Ready to Reduce Risk (3R) study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. Objective: This protocol paper details the design and rationale for the development of the 3R intervention and the study methods used. Methods: This is an open and pragmatic randomized controlled trial with 12 months of follow-up. We recruited participants from primary care and randomly assigned them at a 1:1 frequency, stratified by sex and age, to either a control group (usual care from a general practitioner) or an intervention group involving 2 facilitated group education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognized behavioral change techniques. The primary outcome was medication adherence to statins. The primary measure was an objective, novel, urine-based biochemical measure of medication adherence. We also used the 8-item Morisky Medication Adherence Scale to assess medication adherence. Secondary outcomes were changes in total cholesterol, blood pressure, high-density lipoprotein, total cholesterol to high-density lipoprotein ratio, body mass index, waist to hip ratio, waist circumference, smoking behavior, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs, and overall cardiovascular disease risk score. We also considered process outcomes relating to acceptability and feasibility of the 3R intervention. Results: We recruited 212 participants between May 2015 and March 2017. The 12-month follow-up data collection clinics were completed in April 2018, and data analysis will commence once all study data have been collected and verified. Conclusions: This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of cardiovascular disease. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN16863160; http://www.isrctn.com/ISRCTN16863160 (Archived by WebCite at http://www.webcitation.org/734PqfdQw) International Registered Report Identifier (IRRID): DERR1-10.2196/11289 %M 30425027 %R 10.2196/11289 %U http://www.researchprotocols.org/2018/11/e11289/ %U https://doi.org/10.2196/11289 %U http://www.ncbi.nlm.nih.gov/pubmed/30425027 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 11 %P e10682 %T Testing a Web-Based Interactive Comic Tool to Decrease Obesity Risk Among Minority Preadolescents: Protocol for a Pilot Randomized Control Trial %A Leung,May May %A Mateo,Katrina F %A Verdaguer,Sandra %A Wyka,Katarzyna %+ School of Urban Public Health, Hunter College, 2180 Third Avenue, New York, NY, 10035, United States, 1 2123967774, maymay.leung@hunter.cuny.edu %K mHealth %K pediatric obesity %K vulnerable populations %K minority %K diet %K child %K parents %D 2018 %7 09.11.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Childhood obesity is a public health crisis, particularly in low-income, minority populations in the United States. Innovative and technology-enhanced interventions may be an engaging approach to reach at-risk youth and their parents to improve dietary behaviors and feeding practices. However, such tools are limited, especially ones that are theory-based; co-developed with user-centered approaches; tailored to low-income, minority preadolescents; and include parent-focused content. Objective: The objectives of this study include assessing the feasibility and acceptability and exploring the potential impact of the Intervention INC (Interactive Nutrition Comics for urban, minority preadolescents) Web-based tool, which is focused on decreasing childhood obesity risk in black/African American and Latino children aged 9 to 12 years. Methods: Intervention INC is underpinned by the narrative transportation theory, social cognitive theory, and health belief model, and it was co-developed by children and parents from the intended population. The child component consists of a 6-chapter interactive nutrition comic optimized for use on tablet devices, a goal-setting and self-assessment feature, and weekly text/email messages and reminders. The parental component consists of 6 Web-based newsletters, access to the child comic, and weekly text/email messages and reminders. The tool was evaluated using a pilot, single-blind, 2-group randomized controlled study design. Child-parent dyads were randomized to either the experimental or comparison group and assigned to a targeted behavior (increase fruit/vegetable or water intake) based on initial screening questions. Data were collected at 4 time points: baseline (T1), intervention midpoint (T2), intervention endpoint (T3), and 3 months postintervention (T4). Primary measures comprise usage, usability, and feasibility of the Web-based tool. Secondary measures comprise dietary knowledge, preferences, and intake and anthropometric measures (for child) and feeding practices and home food environment (for parent). Results: Study enrollment was completed in November 2017. A total of 89 child-parent dyads were randomized to either the experimental (n=44) or comparison (n=45) group. Data analysis is currently being conducted. Conclusions: This study aims to implement and assess an innovative approach to deliver health messages and resources to at-risk minority preadolescents and their parents. If found to be acceptable, engaging, feasible, and a potential approach to improve dietary behaviors, a full-fledged randomized controlled trial will be conducted to assess its efficacy and potential impact. Trial Registration: ClinicalTrials.gov NCT03165474; https://clinicaltrials.gov/ct2/show/NCT03165474 (Archived by WebCite at http://www.webcitation.org/73122IjgP) International Registered Report Identifier (IRRID): RR1-10.2196/10682 %M 30413399 %R 10.2196/10682 %U https://www.researchprotocols.org/2018/11/e10682/ %U https://doi.org/10.2196/10682 %U http://www.ncbi.nlm.nih.gov/pubmed/30413399 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 11 %P e10734 %T Patterns of Patients’ Interactions With a Health Care Organization and Their Impacts on Health Quality Measurements: Protocol for a Retrospective Cohort Study %A Benis,Arriel %A Harel,Nissim %A Barak Barkan,Refael %A Srulovici,Einav %A Key,Calanit %+ Faculty of Technology Management, Holon Institute of Technology, POB 305, 52 Golomb Street, Holon, 5810201, Israel, 972 523404890, arrielb@hit.ac.il %K health communication %K population characteristics %K eHealth %K mHealth %K telehealth %K health information systems %K consumer health informatics %K delivery of health care %K machine learning %D 2018 %7 07.11.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Data collected by health care organizations consist of medical information and documentation of interactions with patients through different communication channels. This enables the health care organization to measure various features of its performance such as activity, efficiency, adherence to a treatment, and different quality indicators. This information can be linked to sociodemographic, clinical, and communication data with the health care providers and administrative teams. Analyzing all these measurements together may provide insights into the different types of patient behaviors or more accurately to the different types of interactions patients have with the health care organizations. Objective: The primary aim of this study is to characterize usage profiles of the available communication channels with the health care organization. The main objective is to suggest new ways to encourage the usage of the most appropriate communication channel based on the patient’s profile. The first hypothesis is that the patient’s follow-up and clinical outcomes are influenced by the patient’s preferred communication channels with the health care organization. The second hypothesis is that the adoption of newly introduced communication channels between the patient and the health care organization is influenced by the patient’s sociodemographic or clinical profile. The third hypothesis is that the introduction of a new communication channel influences the usage of existing communication channels. Methods: All relevant data will be extracted from the Clalit Health Services data warehouse, the largest health care management organization in Israel. Data analysis process will use data mining approach as a process of discovering new knowledge and dealing with processing data extracted with statistical methods, machine learning algorithms, and information visualization tools. More specifically, we will mainly use the k-means clustering algorithm for discretization purposes and patients’ profile building, a hierarchical clustering algorithm, and heat maps for generating a visualization of the different communication profiles. In addition, patients’ interviews will be conducted to complement the information drawn from the data analysis phase with the aim of suggesting ways to optimize existing communication flows. Results: The project was funded in 2016. Data analysis is currently under way and the results are expected to be submitted for publication in 2019. Identification of patient profiles will allow the health care organization to improve its accessibility to patients and their engagement, which in turn will achieve a better treatment adherence, quality of care, and patient experience. Conclusions: Defining solutions to increase patient accessibility to health care organization by matching the communication channels to the patient’s profile and to change the health care organization’s communication with the patient to a highly proactive one will increase the patient’s engagement according to his or her profile. International Registered Report Identifier (IRRID): RR1-10.2196/10734 %M 30404769 %R 10.2196/10734 %U http://www.researchprotocols.org/2018/11/e10734/ %U https://doi.org/10.2196/10734 %U http://www.ncbi.nlm.nih.gov/pubmed/30404769 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 11 %P e11372 %T Evaluating the Long-Term Effectiveness of School-Based Depression, Anxiety, and Substance Use Prevention Into Young Adulthood: Protocol for the Climate School Combined Study %A Birrell,Louise %A Newton,Nicola C %A Slade,Tim %A Chapman,Catherine %A Mewton,Louise %A McBride,Nyanda %A Hides,Leanne %A Chatterton,Mary Lou %A Allsop,Steve %A Healy,Annalise %A Mather,Marius %A Quinn,Catherine %A Mihalopoulos,Cathrine %A Teesson,Maree %+ National Health and Medical Research Council Centre of Research Excellence in Mental Health and Substance Use, National Drug & Alcohol Research Centre, University of New South Wales, Randwick Campus, 22-32 King Street, Sydney, 2052, Australia, 61 2 8936 1039, annalise.healy@unsw.edu.au %K alcohol abuse %K prevention %K depression %K anxiety %K costs and cost analysis %K school %K eHealth %D 2018 %7 06.11.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mental health and substance use disorders are the leading causes of global disability in children and youth. Both tend to first onset or escalate in adolescence and young adulthood, calling for effective prevention during this time. The Climate Schools Combined (CSC) study was the first trial of a Web-based combined universal approach, delivered through school classes, to prevent both mental health and substance use problems in adolescence. There is also limited evidence for the cost-effectiveness of school-based prevention programs. Objective: The aim of this protocol paper is to describe the CSC follow-up study, which aims to determine the long-term efficacy and cost-effectiveness of the CSC prevention program for depression, anxiety, and substance use (alcohol and cannabis use) up to 7 years post intervention. Methods: A cluster randomized controlled trial (the CSC study) was conducted with 6386 participants aged approximately 13.5 years at baseline from 2014 to 2016. Participating schools were randomized to 1 of 4 conditions: (1) control (health education as usual), (2) Climate Substance Use (universal substance use prevention), (3) Climate Mental Health (universal mental health prevention), or (4) CSC (universal substance use and mental health prevention). It was hypothesized that the CSC program would be more effective than conditions (1) to (3) in reducing alcohol and cannabis use (and related harms), anxiety, and depression symptoms as well as increasing knowledge related to alcohol, cannabis, anxiety, and depression. This long-term study will invite follow-up participants to complete 3 additional Web-based assessments at approximately 5, 6, and 7 years post baseline using multiple sources of locator information already provided to the research team. The primary outcomes include alcohol and cannabis use (and related harms) and mental health symptoms. An economic evaluation of the program will also be conducted using both data linkage as well as self-report resource use and quality of life measures. Secondary outcomes include self-efficacy, social networks, peer substance use, emotion regulation, and perfectionism. Analyses will be conducted using multilevel mixed-effects models within an intention-to-treat framework. Results: The CSC long-term follow-up study is funded from 2018 to 2022 by the Australian National Health and Medical Research Council (APP1143555). The first follow-up wave commences in August 2018, and the results are expected to be submitted for publication in 2022. Conclusions: This is the first study to provide a long-term evaluation of combined universal substance use and mental health prevention up to 7 years post intervention. Evidence of sustained benefits into early adulthood would provide a scalable, easy-to-implement prevention strategy with the potential for widespread dissemination to reduce the considerable harms, burden of disease, injury, and social costs associated with youth substance use and mental disorders. International Registered Report Identifier (IRRID): PRR1-10.2196/11372 %M 30401663 %R 10.2196/11372 %U https://www.researchprotocols.org/2018/11/e11372/ %U https://doi.org/10.2196/11372 %U http://www.ncbi.nlm.nih.gov/pubmed/30401663 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 11 %P e11298 %T Efficacy of an Online Self-Help Treatment for Comorbid Alcohol Misuse and Emotional Problems in Young Adults: Protocol for a Randomized Controlled Trial %A Frohlich,Jona R %A Rapinda,Karli K %A Schaub,Michael P %A Wenger,Andreas %A Baumgartner,Christian %A Johnson,Edward A %A O'Connor,Roisin M %A Vincent,Norah %A Blankers,Matthijs %A Ebert,David D %A Hadjistavropoulos,Heather %A Mackenzie,Corey S %A Keough,Matthew T %+ Department of Psychology, University of Manitoba, Duff Roblin Building, 190 Dysart Road, Winnipeg, MB, R3T 2N2, Canada, 1 204 474 7400, Matthew.Keough@umanitoba.ca %K alcohol misuse %K anxiety %K cognitive behavioral therapy %K depression %K integrated treatment %K mobile phone %K motivational interviewing %K online %K self-help %D 2018 %7 01.11.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Alcohol misuse and emotional problems (ie, depression and anxiety) are highly comorbid among Canadian young adults. However, there is a lack of integrated, accessible, and evidence-based treatment options for these young adults. Objective: The main goal of this study is to develop and test the efficacy of an integrated, online self-help program designed to target both alcohol misuse and emotional problems. Methods: A two-arm randomized controlled trial design will be used to compare the efficacy of the online integrated treatment to a psychoeducational control group. A target sample of 214 participants will be recruited and randomly assigned to either condition. The integrated treatment will last 8 weeks, and participants will work through 12 modules. Modules will incorporate content based on principles of cognitive behavioral therapy and motivational interviewing. Participants in the control group will receive links to psychoeducational resources and will have access to the full treatment after follow-up. The primary outcome will be the number of Canadian standard drinks consumed in the week leading up the assessment. Secondary outcomes of interest include symptoms of depression, anxiety, alcohol-related problems, quality of life, and use of other drugs. Assessments will be completed at 3 time-points: at baseline, at the end of treatment (ie, 8 weeks), and at follow-up (ie, 24 weeks). Upon completion, data will be analyzed using generalized linear mixed models. Results: Data collection began in June 2018 and will continue until January 2020. Final study results will be submitted for publication by July 2020. Conclusions: Currently, there are no integrated treatments designed to target alcohol misuse and the range of emotional problems experienced by young adults. This research stands to provide an effective, accessible (ie, Web-based), and feasible option to treat the many struggling young adults in this country. Trial Registration: ClinicalTrials.gov ID NCT03406039; https://clinicaltrials.gov/ct2/show/NCT03406039 (Archived by WebCite at http://www.webcitation.org/72fDefnrh) Registered Report Identifier: PRR1-10.2196/11298 %M 30389649 %R 10.2196/11298 %U https://www.researchprotocols.org/2018/11/e11298/ %U https://doi.org/10.2196/11298 %U http://www.ncbi.nlm.nih.gov/pubmed/30389649 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 10 %P e11008 %T Mind-Body Treatment for International English-Speaking Adults With Neurofibromatosis via Live Videoconferencing: Protocol for a Single-Blind Randomized Controlled Trial %A Vranceanu,Ana-Maria %A Zale,Emily L %A Funes,Christopher J %A Macklin,Eric A %A McCurley,Jessica %A Park,Elyse R %A Jordan,Justin T %A Lin,Ann %A Plotkin,Scott R %+ Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 151 Merrimac Street, 6th Floor, Suite 626, Boston, MA, 02114, United States, 1 6177244977, avranceanu@mgh.harvard.edu %K neurofibromatosis %K quality of life %K stress management %K mind-body %K videoconferencing %K resiliency %K mobile phone %D 2018 %7 23.10.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Neurofibromatoses (NF) are rare genetic conditions associated with substantial psychosocial burden and impaired quality of life (QoL). We developed the first NF-tailored mind-body program (the Relaxation Response Resiliency Program for NF) and adapted it for delivery via live videoconferencing to decrease participation barriers and increase its reach. In a pilot randomized controlled trial (RCT), we found that the Relaxation Response Resiliency Program for NF had excellent feasibility and acceptability when delivered via live videoconferencing; furthermore, the Relaxation Response Resiliency Program for NF showed proof of concept in improving QoL compared with an NF-tailored health education control program (the Health Enhancement Program for NF). A fully powered trial is needed to ascertain the efficacy and durability of the Relaxation Response Resiliency Program for NF delivered via secure live videoconferencing among geographically diverse patients. Objective: The objective of this study is to evaluate the efficacy of the Relaxation Response Resiliency Program for NF versus the Health Enhancement Program for NF, both delivered in groups via secure live videoconferencing, among geographically diverse patients with NF across the United States and internationally. Here we describe the protocol, manualized treatments, evaluation plan, and study design. Methods: This is a single-blind RCT. Patients are told that they will be randomized to one of the two stress management programs (stress management program 1: the Relaxation Response Resiliency Program for NF and stress management program 2: the Health Enhancement Program for NF). Patients are recruited from NF-specific national and international foundations and NF clinics across the United States through study ads and a video of participants who have completed the program as part of the pilot study or ongoing trial. Interested participants are screened for eligibility via secure live videoconferencing (self-reported stress and difficulties coping, no change in antidepressant medication within the past 3 months, no psychotherapy within the past 3 months, no major upcoming surgeries within the next 12 months, English speaking, and able to complete questionnaires online and participate in live video interventions) and consent obtained before participation. Both programs are manualized comprising 8 sessions delivered via secure live videoconferencing by trained clinical psychologists. Primary outcomes are physical health QoL and psychological health QoL. Secondary outcomes are social relationship QoL, environment QoL, and psychosocial and resiliency variables. Outcomes are assessed at baseline, posttraining, and 6- and 12-month follow-ups. Results: The trial is ongoing. Thus far, we have recruited 55 patients and aim to recruit a total of 224. Recruitment will close in May 2020; we plan to complete data analyses by June 2021. Conclusions: This trial will answer key questions about the efficacy and durability of the Relaxation Response Resiliency Program for NF via live videoconferencing with English-speaking adults with NF worldwide. If found efficacious, this program can be readily implemented through national and international NF foundations and NF-specific clinics. The virtual model of delivery has extensive applications for patients in rural areas, those with disability or illness that precludes travel to clinics, and those with rare diseases. Trial Registration: ClinicalTrials.gov NCT03406208; https://clinicaltrials.gov/ct2/show/NCT03406208 (Archived by WebCite at http://www.webcitation.org/72ZoTDQ6h) International Registered Report Identifier (IRRID): RR1-10.2196/11008 %M 30355560 %R 10.2196/11008 %U https://www.researchprotocols.org/2018/10/e11008/ %U https://doi.org/10.2196/11008 %U http://www.ncbi.nlm.nih.gov/pubmed/30355560 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 10 %P e11083 %T Hispanic Secondary Stroke Prevention Initiative Design: Study Protocol and Rationale for a Randomized Controlled Trial %A Carrasquillo,Olveen %A Young,BreAnne %A Dang,Stuti %A Fontan,Orieta %A Ferras,Natalie %A Romano,Jose G %A Dong,Chuanhui %A Kenya,Sonjia %+ Division of General Medicine, Miller School of Medicine, University of Miami, 1120 Northwest 14th Street, Clinical Research Building, Room 968, Miami, FL, 33136, United States, 1 305 243 5505, ocarrasquillo@med.miami.edu %K Hispanics %K Latinos %K stroke %K community health care %K community health workers %K randomized controlled trial %K health care disparities %K mobile phones %K mHealth %D 2018 %7 19.10.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hispanic-Latino populations face a disproportionate stroke burden and are less likely to have sufficient control over stroke risk factors in comparison with other ethnic populations. A promising approach to improving chronic health outcomes has been the use of community health workers (CHWs). Objective: The objective of this randomized controlled trial is to evaluate the effectiveness of a CHW intervention among Latino patients at risk of recurrent stroke. Methods: The Hispanic Secondary Stroke Prevention Initiative (HiSSPI) is a randomized clinical trial of 300 Latino participants from South Florida who have experienced a stroke within the last 5 years. Participants randomized into the CHW intervention arm receive health education and assistance with health care navigation and social services through home visits and phone calls. The intervention also includes a mHealth component in which participants also receive daily text messages (short message service). The primary outcome is change in systolic blood pressure at 12 months. Other secondary outcomes include changes in low-density lipoprotein, glycated hemoglobin, and medication adherence. Results: Study enrollment began in 2015 and will be completed by the end of 2018. The first results are expected to be submitted for publication in 2020. Conclusions: HiSSPI is one of the first randomized controlled trials to examine CHW-facilitated stroke prevention and will provide rigorous evidence on the impact of CHWs on secondary stroke risk factors among Latino individuals who have had a stroke. Trial Registration: ClinicalTrials.gov NCT02251834; https://clinicaltrials.gov/ct2/show/NCT02251834 (Archived by WebCite at http://www.webcitation.org/72DgMqftq) International Registered Report Identifier (IRRID): RR1-10.2196/11083 %M 30341050 %R 10.2196/11083 %U http://www.researchprotocols.org/2018/10/e11083/ %U https://doi.org/10.2196/11083 %U http://www.ncbi.nlm.nih.gov/pubmed/30341050 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 10 %P e10977 %T Mobile Phone Text Messaging for Tobacco Risk Communication Among Young Adult Community College Students: Protocol and Baseline Overview for a Randomized Controlled Trial %A Prokhorov,Alexander V %A Khalil,Georges Elias %A Calabro,Karen Sue %A Machado,Tamara Costello %A Russell,Sophia %A Czerniak,Katarzyna W %A Botello,Gabrielle C %A Chen,Minxing %A Perez,Adriana %A Vidrine,Damon J %A Perry,Cheryl L %+ Department of Behavioral Science, MD Anderson Cancer Center, The University of Texas, 1155 Pressler Street, Unit 1330, Houston, TX,, United States, 1 713 563 2605, aprokhor@mdanderson.org %K tobacco use %K risk %K perception %K text messaging %K young adult %D 2018 %7 15.10.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Community-college students are at high risk for tobacco use. Because the use of mobile phone text messaging is nearly ubiquitous today, short message service (SMS) may be an effective strategy for tobacco risk communication in this population. Little is known, however, concerning the message structure significantly influencing perceived tobacco risk. Objective: We aim to outline the rationale and design of Project Debunk, a randomized trial comparing the effects of different SMS text message structures. Methods: We conducted a 6-month randomized trial comparing 8 arms, based on the combination of the 3 message structures delivered to young adults in a 2×2×2 study design: framing (gain-framed or loss-framed), depth (simple or complex), and appeal (emotional or rational). Participants were invited to participate from 3 community colleges in Houston from September 2016 to July 2017. Participants were randomized to 1 arm and received text messages in 2 separate campaigns. Each campaign consisted of 2 text messages per day for 30 days. Perceived tobacco risk was assessed at baseline, 2 months after the first campaign, and 2 months after the second campaign. We assessed the perceived risk of using conventional products (eg, combustible cigarettes) and new and emerging products (eg, electronic cigarettes). The validity of message structures was assessed weekly for each campaign. A 1-week follow-up assessment was also conducted to understand immediate reactions from participants. Results: We completed data collection for the baseline survey on a rolling basis during this time and assessed the validity of the message structure after 1 week of SMS text messages. For the entire sample (N=636), the average age was 20.92 years (SD 2.52), about two-thirds were male (430/636, 67.6%), and most were black or African American (259/636, 40.7%) or white (236/636, 37.1%). After 1 week of receiving text messages, the following was noted: (a) loss-framed messages were more likely to be perceived as presenting a loss than gain-framed messages (F7,522=13.13, P<.001), (b) complex messages were perceived to be more complex than simple messages (F7,520=2.04, P=.05), and (c) emotional messages were perceived to be more emotionally involving than rational messages (F7,520=6.46, P<.001). Conclusions: This study confirms that the recruitment, randomization, and message composition have been successfully implemented. Further analyses will identify specific types of messages that are more effective than others in increasing the perceived risk of tobacco use. If our results suggest that any of the 8 specific message structures are more effective for helping young adults understand tobacco risk, this would provide evidence to include such messages as part of a larger technology-based campaign such as mobile phone apps, entertainment-based campaigns, and social media. Trial Registration: ClinicalTrials.gov NCT03457480; https://clinicaltrials.gov/ct2/show/NCT03457480 (Archived by WebCite at http://www.webcitation.org/6ykd4IIap) Registered Report Identifier: RR1-10.2196/10977 %M 30322833 %R 10.2196/10977 %U http://www.researchprotocols.org/2018/10/e10977/ %U https://doi.org/10.2196/10977 %U http://www.ncbi.nlm.nih.gov/pubmed/30322833 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 8 %P e11375 %T Empowering With PrEP (E-PrEP), a Peer-Led Social Media–Based Intervention to Facilitate HIV Preexposure Prophylaxis Adoption Among Young Black and Latinx Gay and Bisexual Men: Protocol for a Cluster Randomized Controlled Trial %A Patel,Viraj V %A Ginsburg,Zoë %A Golub,Sarit A %A Horvath,Keith J %A Rios,Nataly %A Mayer,Kenneth H %A Kim,Ryung S %A Arnsten,Julia H %+ Division of General Internal Medicine, Department of Medicine, Montefiore Health System / Albert Einstein College of Medicine, 3300 Kossuth Avenue, Bronx, NY, 10467, United States, 1 718 920 5256, vpatel@montefiore.org %K pre-exposure prophylaxis %K HIV %K social media interventions %K HIV prevention %K social network intervention %K social media %K social networking %K telemedicine %D 2018 %7 28.08.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young black and Latinx, gay, bisexual, and other men who have sex with men (YBLGBM, aged 18-29 years) have among the highest rates of new HIV infections in the United States and are not consistently reached by existing prevention interventions. Preexposure prophylaxis (PrEP), an oral antiretroviral regimen taken daily by HIV-uninfected individuals to prevent HIV acquisition, is highly efficacious in reducing HIV acquisition and could help stop the HIV epidemic in YBLGBM. Use of social media (eg, Facebook, Twitter, online dating sites) is ubiquitous among young people, providing an efficient avenue to engage YBLGBM to facilitate PrEP adoption. Objective: Our overall goal was to develop and pilot test a theoretically grounded, social media–based, peer-led intervention to increase PrEP uptake in YBLGBM. We used diffusion of innovation and information-motivation-behavioral skills frameworks to (1) identify potential factors associated with interest in and adoption of PrEP among YBLGBM; (2) develop Empowering with PrEP (E-PrEP), a social media–based, peer-led intervention to increase PrEP uptake in YBLGBM; and (3) pilot test the feasibility and acceptability of E-PrEP, and determine its preliminary efficacy for increasing adoption of PrEP by YBLGBM. We describe the development and protocol for E-PrEP. Methods: Using a participatory research approach, we partnered with YBLGBM intervention development partners to develop a social media–based behavioral intervention to facilitate PrEP uptake, which involved an online messaging campaign disseminated by YBLGBM peer leaders to their existing online networks. We designed the 6-week campaign to provide education about PrEP, increase motivation to use PrEP, and facilitate access to PrEP. We then conducted a cluster-randomized trial of E-PrEP compared with an attention-matched general health control condition (E-Health) among YBLGBM aged 18 to 29 years to assess E-PrEP’s feasibility, acceptability, preliminary efficacy for increasing self-reported intention to use PrEP, PrEP uptake, and impact on knowledge and attitudes about PrEP at 12-week follow-up (6 weeks after the end of the online campaign). Results: From October 2016 to March 2017, we developed, pretested, and refined E-PrEP with 6 YBLGBM intervention development partners. From May to June 2017, we recruited, enrolled, and randomly assigned 10 peer leaders (n=5 for each condition). The 10 peer leaders then recruited and enrolled 152 participants from their existing online networks (range 3-33 per peer leader), during June and July 2017. Intervention follow-up was completed after 12 weeks, in November 2017, with analyses underway. Conclusions: We hypothesize that, compared with E-Health, participants randomly assigned to E-PrEP will be more likely to express intention to use PrEP and greater PrEP uptake, and will also show changes in potential mediators of PrEP uptake (knowledge, attitudes, stigma, and access). A Web-based biobehavioral intervention model such as E-PrEP could be rapidly scaled even with limited resources and have significant population-level impact. Trial Registration: ClinicalTrials.gov NCT03213366; https://clinicaltrials.gov/ct2/show/NCT03213366 (Archived by WebCite at http://www.webcitation.org/71onSdcXY) Registered Report Identifier: RR1-10.2196/11375 %M 30154071 %R 10.2196/11375 %U http://www.researchprotocols.org/2018/8/e11375/ %U https://doi.org/10.2196/11375 %U http://www.ncbi.nlm.nih.gov/pubmed/30154071 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 8 %P e10789 %T A Co-Designed, Culturally-Tailored mHealth Tool to Support Healthy Lifestyles in Māori and Pasifika Communities in New Zealand: Protocol for a Cluster Randomized Controlled Trial %A Verbiest,Marjolein %A Borrell,Suaree %A Dalhousie,Sally %A Tupa'i-Firestone,Ridvan %A Funaki,Tevita %A Goodwin,Deborah %A Grey,Jacqueline %A Henry,Akarere %A Hughes,Emily %A Humphrey,Gayle %A Jiang,Yannan %A Jull,Andrew %A Pekepo,Crystal %A Schumacher,Jodie %A Te Morenga,Lisa %A Tunks,Megan %A Vano,Mereaumate %A Whittaker,Robyn %A Ni Mhurchu,Cliona %+ National Institute for Health Innovation, School of Population Health, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand, 64 9 923 4494, c.nimhurchu@auckland.ac.nz %K behavior change %K randomized controlled trial %K co-design %K mHealth %K health behavior %K noncommunicable diseases %K New Zealand %K Māori %K Pasifika %D 2018 %7 22.08.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: New Zealand urgently requires scalable, effective, behavior change programs to support healthy lifestyles that are tailored to the needs and lived contexts of Māori and Pasifika communities. Objective: The primary objective of this study is to determine the effects of a co-designed, culturally tailored, lifestyle support mHealth tool (the OL@-OR@ mobile phone app and website) on key risk factors and behaviors associated with an increased risk of noncommunicable disease (diet, physical activity, smoking, and alcohol consumption) compared with a control condition. Methods: A 12-week, community-based, two-arm, cluster-randomized controlled trial will be conducted across New Zealand from January to December 2018. Participants (target N=1280; 64 clusters: 32 Māori, 32 Pasifika; 32 clusters per arm; 20 participants per cluster) will be individuals aged ≥18 years who identify with either Māori or Pasifika ethnicity, live in New Zealand, are interested in improving their health and wellbeing or making lifestyle changes, and have regular access to a mobile phone, tablet, laptop, or computer and to the internet. Clusters will be identified by community coordinators and randomly assigned (1:1 ratio) to either the full OL@-OR@ tool or a control version of the app (data collection only plus a weekly notification), stratified by geographic location (Auckland or Waikato) for Pasifika clusters and by region (rural, urban, or provincial) for Māori clusters. All participants will provide self-reported data at baseline and at 4- and 12-weeks postrandomization. The primary outcome is adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score at 12 weeks that assesses smoking behavior, fruit and vegetable intake, alcohol intake, and physical activity. Secondary outcomes include self-reported body weight, holistic health and wellbeing status, medication use, and recorded engagement with the OL@-OR@ tool. Results: Trial recruitment opened in January 2018 and will close in July 2018. Trial findings are expected to be available early in 2019. Conclusions: Currently, there are no scalable, evidence-based tools to support Māori or Pasifika individuals who want to improve their eating habits, lose weight, or be more active. This wait-list controlled, cluster-randomized trial will assess the effectiveness of a co-designed, culturally tailored mHealth tool in supporting healthy lifestyles. Trial Registration: Australia New Zealand Clinical Trials Register ACTRN12617001484336; http://www.ANZCTR.org.au/ACTRN12617001484336.aspx (Archived by WebCite at http://www.webcitation.org/71DX9BsJb) Registered Report Identifier: RR1-10.2196/10789 %M 30135054 %R 10.2196/10789 %U http://www.researchprotocols.org/2018/8/e10789/ %U https://doi.org/10.2196/10789 %U http://www.ncbi.nlm.nih.gov/pubmed/30135054 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 8 %P e10849 %T Internet-Based Universal Prevention for Students and Parents to Prevent Alcohol and Cannabis Use Among Adolescents: Protocol for the Randomized Controlled Trial of Climate Schools Plus %A Newton,Nicola Clare %A Chapman,Cath %A Slade,Tim %A Conroy,Chloe %A Thornton,Louise %A Champion,Katrina Elizabeth %A Stapinski,Lexine %A Koning,Ina %A Teesson,Maree %+ National Health and Medical Research Council Centre of Research Excellence in Mental Health and Substance Use, National Drug and Alcohol Research Centre, University of New South Wales, 22-32 King Street, Randwick, 2031, Australia, 61 93850333, n.newton@unsw.edu.au %K alcohol %K Australia %K cannabis %K parents %K prevention %K school %K internet-based intervention %D 2018 %7 17.08.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Early initiation of alcohol and cannabis use markedly increases the risk of harms associated with use, including the development of substance use and mental health disorders. To interrupt this trajectory, effective prevention during the adolescent period is critical. Despite evidence showing that parents can play a critical role in delaying substance use initiation, the majority of prevention programs focus on adolescents only. Accordingly, the Climate Schools Plus (CSP) program was developed to address this gap. Objective: This paper outlines the protocol for a cluster randomized controlled trial (RCT) of the CSP program, a novel internet-based program for parents and students to prevent adolescent substance use and related harms. The CSP program builds on the success of the Climate Schools student programs, with the addition of a newly developed parenting component, which allows parents to access the internet-based content to equip them with knowledge and skills to help prevent substance use in their adolescents. Methods: A cluster RCT is being conducted with year 8 students (aged 12-14 years) and their parents from 12 Australian secondary schools between 2018 and 2020. Using blocked randomization, schools are assigned to one of the two groups to receive either the CSP program (intervention) or health education as usual (control). The primary outcomes of the trial will be any student alcohol use (≥1 standard alcoholic drink/s) and any student drinking to excess (≥5 standard alcoholic drinks). Secondary outcomes will include alcohol- and cannabis-related knowledge, alcohol use-related harms, frequency of alcohol consumption, frequency of drinking to excess, student cannabis use, parents’ self-efficacy to stop their children using alcohol, parental supply of alcohol, and parent-adolescent communication. All students and their parents will complete assessments on three occasions—baseline and 12 and 24 months postbaseline. In addition, students and parents in the intervention group will be asked to complete program evaluations on two occasions—immediately following the year 8 program and immediately following the year 9 program. Results: Analyses will be conducted using multilevel, mixed-effects models within an intention-to-treat framework. It is expected that students in the intervention group will have less uptake and excessive use of alcohol compared with the students in the control group. Conclusions: This study will provide the first evaluation of a combined internet-based program for students and their parents to prevent alcohol and cannabis use. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618000153213; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374178 (Archived by WebCite at http://www.webcitation.org/71E0prqfQ) Registered Report Identifier: RR1-10.2196/10849 %M 30120084 %R 10.2196/10849 %U http://www.researchprotocols.org/2018/8/e10849/ %U https://doi.org/10.2196/10849 %U http://www.ncbi.nlm.nih.gov/pubmed/30120084 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 8 %P e169 %T Technologies for Innovative Monitoring to Reduce Blood Pressure and Change Lifestyle Using Mobile Phones in Adult and Elderly Populations (TIM Study): Protocol for a Randomized Controlled Trial %A Fuchs,Sandra C %A Harzheim,Erno %A Iochpe,Cirano %A David,Caroline N de %A Gonçalves,Marcelo R %A Sesin,Guilhermo P %A Costa,Cassio M %A Moreira,Leila B %A Fuchs,Flavio D %+ Postgraduate Studies Program in Cardiology, Hospital de Clinicas de Porto Alegre, School of Medicine, Universidade Federal do Rio Grande do Sul, Ramiro Barcelos 2350, Centro de Pesquisa Clínica, 5th Floor, Porto Alegre,, Brazil, 55 51 3359 7621, sfuchs@hcpa.edu.br %K blood pressure %K blood pressure monitoring %K hypertension %K weight %K diet %K sodium %K physical activity %K randomized controlled trial %K text messages %D 2018 %7 07.08.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension is a growing problem worldwide, markedly in low- and middle-income countries, where the rate of control slightly decreased. The overall prevalence of hypertension in Brazil is 28.7% among adult individuals and 68.9% in the population aged 60 years and older, and less than a third of patients have controlled blood pressure (BP). The use of technologies—mobile phones and the internet—to implement interventions to reduce blood pressure can minimize costs and diminish cardiovascular risk. Interventions through text messaging and electronic BP monitoring present divergent results. Objective: This trial evaluates the effectiveness of interventions—personalized messages and telemonitoring of BP—to reduce systolic BP and improve lifestyle compared to the usual care of patients with hypertension (control group). Methods: This factorial randomized controlled trial enrolls individuals aged 30 to 75 years who have a mobile phone and internet access with the diagnosis of hypertension under drug treatment with up to 2 medications and uncontrolled BP. Eligible participants should have both increased office BP and 24-hour BP with ambulatory BP monitoring. Participants with severe hypertension (systolic BP ≥180 or diastolic BP ≥110 mm Hg), life threatening conditions, low life expectancy, recent major cardiovascular event (last 6 months), other indications for the use of antihypertensive medication, diagnosis of secondary hypertension, pregnant or lactating women, or those unable to understand the interventions are excluded. Participants are randomly allocate to 1 of 4 experimental arms: (1) Telemonitoring of blood pressure (TELEM) group: receives an automatic oscillometric device to measure BP, (2) telemonitoring by text message (TELEMEV) group: receives personalized, standardized text messages to stimulate lifestyle changes and adhere with BP-lowering medication, (3) TELEM-TELEMEV group: receives both interventions, and (4) control group: receives usual clinical treatment (UCT). Data collection is performed in a clinical research center located in a referent hospital. The primary outcomes are reduction of systolic BP assessed by 24-hour ambulatory BP monitoring (primary outcome) and change of lifestyle (based on dietary approaches to stop hypertension (DASH)-type diet, sodium restriction, weight loss or control, increase of physical activity). Results: This study was funded by two Brazilian agencies: the National Council for Scientific and Technological Development and Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul. Enrollment was completed at the end of 2017 (N=231), the follow-up is ongoing, and data analysis is expected to begin in early 2019. A reduction of 24-hour systolic BP of approximately 8.8 [SD 13.1] mm Hg for participants in the BP monitoring group versus 3.4 [SD 11.6] mm Hg in the UCT group is expected. A similar reduction in the text messaging group is expected. Conclusions: The use of mobile technologies connected to the internet through mobile phones promotes time optimization, cost reduction, and better use of public health resources. However, it has not been established whether simple interventions such as text messaging are superior to electronic BP monitoring and whether both outperform conventional counseling. Trial Registration: ClinicalTrials.gov NCT03005470; https://clinicaltrials.gov/ct2/show/NCT03005470 (Archived by WebCite at http://www.webcitation.org/70AoANESu). Plataforma Brasil CAAE 31423214.0.0000.5327. Registered Report Identifier: RR1-10.2196/9619 %M 30087093 %R 10.2196/resprot.9619 %U http://www.researchprotocols.org/2018/8/e169/ %U https://doi.org/10.2196/resprot.9619 %U http://www.ncbi.nlm.nih.gov/pubmed/30087093 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 7 %P e10322 %T Minimally Invasive Dentistry Based on Atraumatic Restorative Treatment to Manage Early Childhood Caries in Rural and Remote Aboriginal Communities: Protocol for a Randomized Controlled Trial %A Arrow,Peter %A McPhee,Rob %A Atkinson,David %A Mackean,Tamara %A Kularatna,Sanjeewa %A Tonmukayakul,Utsana %A Brennan,David %A Palmer,David %A Nanda,Soniya %A Jamieson,Lisa %+ Western Australia Dental Health Services, Research and Evaluation, Health Department of Western Australia, 43 Mount Henry Road, Como, Perth, 6152, Australia, 61 8 93130600, parrow@ozemail.com.au %K cost-effectiveness analysis %K early childhood caries %K health utility %K health-related quality of life %D 2018 %7 25.07.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: The caries experience of Aboriginal children in Western Australia (WA) and elsewhere in Australia is more than twice that of non-Aboriginal children. Early childhood caries (caries among children <6 years) has a significant impact on the quality of life of children and their caregivers, and its management is demanding and commonly undertaken under general anesthesia. A randomized controlled trial using a minimally invasive dentistry approach based on Atraumatic Restorative Treatment (ART) in metropolitan Perth, WA, has demonstrated a significant reduction in the rate of referral to a dental specialist for dental care among children with early childhood caries, potentially reducing the need for treatment under general anesthesia. The tested approach was clinically successful and was without adverse effects on child dental anxiety. The model of ART-based primary care requires further testing and development if similar outcomes for Aboriginal children in remote and rural settings are to be achieved. Objective: The study aims to develop, implement, and evaluate a remote primary care model to deliver effective primary dental services, encompassing treatment and preventive services, to Aboriginal preschool children (based on minimally invasive approaches including ART). Methods: This is a two-arm parallel cluster randomized controlled study in which a test group will be provided with the intervention treatment at the start of the study and a control group will be provided with the intervention treatment 12 months after study commencement (delayed intervention). Participating communities, stratified by size of community (ie, number of children in the sample frame) and baseline caries experience, will be randomly assigned using a computer-generated block randomized list into immediate (test group) or delayed intervention (control group; provided with standard care). Informed consent will be obtained from all participants. Aboriginal research assistants will explain the study to the parents and assist the parents in completing the questionnaires. Participants in the randomized study will be examined at baseline and at 12 months follow-up by a calibrated examiner. Test group participants will subsequently be contacted and appropriate appointments coordinated for treatment. Control group participants will be provided with standard preventive care by the Aboriginal Health Workers and managed for treatment as per standard procedures. Results: Community consultations have been undertaken and 26 communities have agreed to participate. Fieldwork is in progress to recruit study participants. Conclusions: The significance of the study lies in its holistic approach to testing the model of care. Clinical evaluations as well as oral health‒related quality of life evaluations will be undertaken. Cost-effectiveness and cost-utility evaluations will assist in the development of policy options for oral health services for rural and remote communities. The elicitation of caregiver perspectives through focus group interviews will supplement the clinical, psychosocial, and cost-utility evaluations and provide a richer evaluation of the intervention. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616001537448; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371735 (Archived by WebCite at http://www.webcitation.org/70UMxndFZ) Registered Report Identifier: RR1-10.2196/10322 %M 30045834 %R 10.2196/10322 %U http://www.researchprotocols.org/2018/7/e10322/ %U https://doi.org/10.2196/10322 %U http://www.ncbi.nlm.nih.gov/pubmed/30045834 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 7 %P e11106 %T The Family Check-Up Online Program for Parents of Middle School Students: Protocol for a Randomized Controlled Trial %A Danaher,Brian G %A Seeley,John R %A Stormshak,Elizabeth A %A Tyler,Milagra S %A Caruthers,Allison S %A Moore,Kevin J %A Cardenas,Lucia %+ Prevention Science Institute, University of Oregon, 6217 University of Oregon, Eugene, OR, 97403, United States, 1 541 346 4490, bdanaher@uoregon.edu %K family treatment %K parent-child treatment %K school mental health %K internet intervention %K eHealth intervention %K prevention science %K family relations %K parent-child relations %K school health services %K mental health services %K telehealth %K preventive psychiatry %K preventive health services %D 2018 %7 18.07.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Research has established that skillful family management during adolescence protects youth from a variety of mental health and behavioral problems. Interventions associated with this research have focused on parenting skills as the mediator that links early risk factors with a profile of later behavioral risk, including problem behavior, substance use, and school failure. Fortunately, positive changes in family management skills have been linked to meaningful improvements in adolescent behavior, and these improvements have been significant across a variety of cultural groups. Objective: We describe the background, research design, and intervention components of an electronic health version of the Family Check-Up program that is targeting middle school children and is being evaluated in a randomized controlled trial for its usability, feasibility, and efficacy. Methods: We used an iterative formative research process to develop an electronic health version of the Family Check-Up program. In our ongoing randomized controlled trial, eligible families are randomly assigned to 1 of 3 conditions: Family Check-Up Online-only (n≈100), Family Check-Up Online + Coach (n≈100), and a waitlist control condition (middle school as usual; n≈100). We are conducting assessments at baseline, 3 months following randomization (posttest), and at follow-ups scheduled for 6 months and 12 months. Results: This randomized controlled trial project was funded in 2015. Participant recruitment was completed in spring 2018 and enrollment is ongoing. Follow-up assessments will be completed in 2019. Conclusions: The innovative Family Check-Up Online program has the potential to help address many of the barriers that more traditional school-based behavioral mental health implementation strategies have yet to solve, including staffing and resources to implement family-centered support within schools. Trial Registration: ClinicalTrials.gov NCT03060291; https://clinicaltrials.gov/ct2/show/NCT03060291 (Archived by WebCite at http://www.webcitation.org/70f8keeN4) Trial Registration: RR1-10.2196/11106 %M 30021712 %R 10.2196/11106 %U http://www.researchprotocols.org/2018/7/e11106/ %U https://doi.org/10.2196/11106 %U http://www.ncbi.nlm.nih.gov/pubmed/30021712 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 6 %P e150 %T Individually Tailored, Adaptive Intervention to Manage Gestational Weight Gain: Protocol for a Randomized Controlled Trial in Women With Overweight and Obesity %A Symons Downs,Danielle %A Savage,Jennifer S %A Rivera,Daniel E %A Smyth,Joshua M %A Rolls,Barbara J %A Hohman,Emily E %A McNitt,Katherine M %A Kunselman,Allen R %A Stetter,Christy %A Pauley,Abigail M %A Leonard,Krista S %A Guo,Penghong %+ Exercise Psychology Laboratory, Department of Kinesiology, College of Health and Human Development, The Pennsylvania State University, 266 Recreation Building, University Park, PA, 16802, United States, 1 8148630456, dsd11@psu.edu %K adaptive intervention %K randomized controlled trial %K mHealth %K intervention study %K overweight %K obesity %K pregnant women %K exercise %K nutrition science %K gestational weight gain %K body weight maintenance %D 2018 %7 08.06.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain. Objective: The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity. Methods: The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain. Results: Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018. Conclusions: This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application. Registered Report Identifier: RR1-10.2196/9220 %M 29884603 %R 10.2196/resprot.9220 %U http://www.researchprotocols.org/2018/6/e150/ %U https://doi.org/10.2196/resprot.9220 %U http://www.ncbi.nlm.nih.gov/pubmed/29884603 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 6 %P e144 %T Enhancing Executive Functions Among Dutch Elementary School Children Using the Train Your Mind Program: Protocol for a Cluster Randomized Trial %A Bervoets,Joachim %A Jonkman,Lisa M %A Mulkens,Sandra %A de Vries,Hein %A Kok,Gerjo %+ Department of Work & Social Psychology, Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433884342, j.bervoets@maastrichtuniversity.nl %K executive function %K children %K socioemotional development, cognitive development %K academic performance %K physical activity %K healthy eating %K eHealth %D 2018 %7 07.06.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Executive functions are higher cognitive control functions, which are essential to physical and psychological well-being, academic performance, and healthy social relationships. Executive functions can be trained, albeit without broad transfer, to this date. Broad transfer entails the translation of improved cognitive functions to daily life (behaviors). The intervention Train your Mind was designed to train executive functions among elementary school children aged 9 to 11 years, and obtain broad transfer in terms of enhanced physical activity, healthy eating, and socioemotional regulation. Objective: This paper aims to describe the cluster randomized trial to test the effectiveness of the Train your Mind intervention. Methods: Train your Mind was integrated into the existing school curriculum for 8 months (25 weeks excluding holidays). The effectiveness of the intervention was tested in a cluster randomized trial comprising 13 schools, 34 groups (school classes), and 800 children, using a battery of 6 computer tasks at pre- and postmeasurement. Each of the 3 core executive functions was measured by 2 tasks (Flanker and Go/No-Go; N-Back and Running Span; Attention Switching Task and Dots/Triangles). Moreover, we administered questionnaires that measure emotion-regulation, cognitive errors, physical activity, dietary habits, and the psycho-social determinants of diet and physical activity. Body mass index was also measured. Multilevel analyses will account for clustering at the school and group levels, and randomization took place at the school level. Results: Results are currently being analyzed. Conclusions: The main purpose of this study is to test Train your Mind’s effectiveness in enhancing executive functions. Second, we investigate whether increased executive functions lead to improved physical activity and healthy eating. If found effective, executive function training could easily be integrated into school curricula everywhere, and as such, boost health, academic performance, and emotion-regulation of elementary school children, in a cost-effective manner. Trial Registration: Netherlands Trial Register NTR5804; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5804 (Archived by WebCite at http://www.webcitation.org/6z9twosJ8) Registered Report Identifier: RR1-10.2196/7908 %R 10.2196/resprot.7908 %U http://www.researchprotocols.org/2018/6/e144/ %U https://doi.org/10.2196/resprot.7908 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 6 %P e10494 %T A Self-Paced, Web-Based, Positive Emotion Skills Intervention for Reducing Symptoms of Depression: Protocol for Development and Pilot Testing of MARIGOLD %A Cheung,Elaine O %A Addington,Elizabeth L %A Bassett,Sarah M %A Schuette,Stephanie A %A Shiu,Eva W %A Cohn,Michael A %A Leykin,Yan %A Saslow,Laura R %A Moskowitz,Judith T %+ Department of Medical Social Sciences, Osher Center for Integrative Medicine, Northwestern University Feinberg School of Medicine, 625 N Michigan, Suite #2700, Chicago, IL, 60611, United States, 1 3125034388, elaine-cheung@northwestern.edu %K emotions %K depression %K telemedicine %K happiness %K mobile apps %D 2018 %7 05.06.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Living with elevated symptoms of depression can have debilitating consequences for an individual’s psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. Objective: The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. Methods: This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. Results: The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. Conclusions: Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion. Trial Registration: ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k). Registered Report Identifier: RR1-10.2196/10494 %R 10.2196/10494 %U http://www.researchprotocols.org/2018/6/e10494/ %U https://doi.org/10.2196/10494 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 6 %P e151 %T Using mHealth to Increase Treatment Utilization Among Recently Incarcerated Homeless Adults (Link2Care): Protocol for a Randomized Controlled Trial %A Reingle Gonzalez,Jennifer M %A Businelle,Michael S %A Kendzor,Darla %A Staton,Michele %A North,Carol S %A Swartz,Michael %+ Department of Epidemiology, Human Genetics and Environmental Sciences, University of Texas School of Public Health, 6011 Harry Hines Blvd, V8.112, Dallas, TX, 75390, United States, 1 4703338749, jennifer.reingle@utsouthwestern.edu %K case management %K criminal justice %K treatment %D 2018 %7 05.06.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is a significant revolving door of incarceration among homeless adults. Homeless adults who receive professional coordination of individualized care (ie, case management) during the period following their release from jail experience fewer mental health and substance use problems, are more likely to obtain stable housing, and are less likely to be reincarcerated. This is because case managers work to meet the various needs of their clients by helping them to overcome barriers to needed services (eg, food, clothing, housing, job training, substance abuse and mental health treatment, medical care, medication, social support, proof of identification, and legal aid). Many barriers (eg, limited transportation, inability to schedule appointments, and limited knowledge of available services) prevent homeless adults who were recently released from incarceration from obtaining available case management, crisis management, substance abuse, and mental health services. Objective: The aim of the Link2Care study is to assess the effectiveness of a smartphone app for increasing case management and treatment service utilization, and in turn reduce homelessness and rearrest. The goals of this research are to (1) assess the impact of an innovative smartphone app that will prompt and directly link recently incarcerated homeless adults to community-based case management services and resources and (2) utilize in-person and smartphone-based assessments to identify key variables (eg, alcohol or drug use, social support, psychological distress, and quality of life) that predict continued homelessness and rearrest. Methods: Homeless adults (N=432) who enroll in a shelter-based Homeless Recovery Program after release from the Dallas County Jail will be randomly assigned to one of the three treatment groups: (1) usual case management, (2) usual case management plus smartphone, and (3) usual case management with a study-provided smartphone that is preloaded with an innovative case management app (smartphone-based case management). Those assigned to smartphone-based case management will receive smartphones that prompt (twice weekly) connections to shelter-based case managers. The app will also offer direct links to case managers (available during normal business hours) and crisis interventionists (available 24 hours a day, 7 days a week) with the touch of a button. Results: Recruitment began in the spring of 2018, and data collection will conclude in 2021. Conclusions: This research represents an important step toward integrated service connection and health care service provision for one of the most underserved, high need, and understudied populations in the United States. Trial Registration: ClinicalTrials.gov NCT03399500; https://clinicaltrials.gov/ct2/show/NCT03399500 (Archived by WebCite at http://www.webcitation.org/6zSJwdgUS) Registered Report Identifier: RR1-10.2196/9868 %R 10.2196/resprot.9868 %U http://www.researchprotocols.org/2018/6/e151/ %U https://doi.org/10.2196/resprot.9868 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 5 %P e133 %T A Self-Directed Mobile Intervention (WaznApp) to Promote Weight Control Among Employees at a Lebanese University: Protocol for a Feasibility Pilot Randomized Controlled Trial %A Bardus,Marco %A Hamadeh,Ghassan %A Hayek,Bouchra %A Al Kherfan,Rawan %+ Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, Van Dyck - Room 302, PO Box 11-0236 Riad El Solh, Beirut, 1107 2020, Lebanon, 961 1 350 000  ext 4694, marco.bardus@gmail.com %K mobile apps %K weight loss %K physical activity %K healthy diet %K workplace %K mHealth %K randomized controlled trial %D 2018 %7 16.05.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Overweight and obesity have become major health problems globally with more than 1.9 billion overweight adults. In Lebanon, the prevalence of obesity and overweight is 65.4% combined. Risk factors of obesity and overweight are preventable and can be addressed by modifications in the environment and in an individual’s lifestyle. Mobile technologies are increasingly used in behavioral, self-directed weight management interventions, providing users with additional opportunities to attain weight control (weight loss, weight gain prevention, etc). Mobile apps may allow for the delivery of Just-in-Time Adaptive Interventions (JITAIs), which provide support through skill building, emotional support, and instrumental support, following the participants’ progress. A few commercially available apps offer JITAI features, but no studies have tested their efficacy. Objective: The primary objective of this study is to examine the feasibility of a self-directed weight loss intervention, targeting employees of an academic institution, using a virtual coaching app with JITAI features (Lark) and a self-help calorie-counting app (MyFitnessPal). The secondary objective is to estimate the effects of the intervention on main study outcomes. Methods: This study is a single-center, parallel, randomized controlled trial with 2 study arms (intervention and control). Participants will be randomly allocated in equal proportions to the intervention (Lark) and control groups (MyFitnessPal). To be eligible for this study, participants must be employed full- or part-time at the university or its medical center, able to read English, have a smartphone, and be interested in controlling their weight. Recruitment strategies entail email invitations, printed posters, and social media postings. We will assess quantitative rates of recruitment, adherence, and retention, self-reported app quality using the user version of the Mobile App Rating Scale. We will also assess changes in weight-related outcomes (absolute weight and waist circumference), behavioral outcomes (physical activity and diet), and cognitive factors (motivation to participate in the trial and to manage weight). Results: WaznApp was funded in June 2017, and recruitment started in March 2018. Conclusions: This study will provide information as to whether the selected mobile apps offer a feasible solution for promoting weight management in an academic workplace. The results will inform a larger trial whose results might be replicated in similar workplaces in Lebanon and the Middle East and North Africa region, and will be used as a benchmark for further investigations in other settings and similar target groups. Trial Registration: ClinicalTrials.gov NCT03321331; https://clinicaltrials.gov/ct2/show/NCT03321331 (Archived by WebCite at http://www.webcitation.org/6ys9NOLo5) Registered Report Identifier: RR1-10.2196/9793 %M 29769174 %R 10.2196/resprot.9793 %U http://www.researchprotocols.org/2018/5/e133/ %U https://doi.org/10.2196/resprot.9793 %U http://www.ncbi.nlm.nih.gov/pubmed/29769174 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 5 %P e130 %T Engagement Strategies for Self-Monitoring Symptoms of Bipolar Disorder With Mobile and Wearable Technology: Protocol for a Randomized Controlled Trial %A Cochran,Amy %A Belman-Wells,Livia %A McInnis,Melvin %+ Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, K6/446 CSC, 600 Highland Ave., Madison, WI, 53792, United States, 1 608 262 0772, cochran4@wisc.edu %K bipolar disorder %K self-management %K patient participation %K mobile applications %K wearable electronic devices %D 2018 %7 10.05.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Monitoring signs and symptoms in bipolar disorder (BP) is typically based on regular assessments from patient-clinician interactions. Mobile and wearable technology promises to make monitoring symptoms in BP easier, but little is known about how best to engage individuals with BP in monitoring symptoms. Objective: The objective of this study was to provide the rationale and protocol for a randomized controlled trial that investigates engagement strategies for monitoring symptoms of BP, including the strategies of using activity trackers compared with self-reports and reviewing recorded symptoms weekly with an interviewer. Methods: A total of 50 individuals with BP will be recruited from the Prechter Longitudinal Study of Bipolar Disorder at the University of Michigan to participate in a 6-week study. Participants will monitor their symptoms through an activity tracker (Fitbit Alta HR) and a mobile phone app designed for this study. In addition to monitoring symptoms, participants have a 50-50 chance of being assigned to an arm that reviews self-reports and activity information weekly. Statistical tests will be performed to test hypotheses that participants adhere to activity tracking significantly more than self-reporting, prefer activity tracking significantly more than self-reporting, and better adhere to both activity tracking and self-reporting when reviewing collected information weekly. Results: Recruitment commenced in November 2017. The first group of participants began the study in January 2018. Conclusions: This study aims to establish strategies to engage individuals with BP in monitoring their symptoms with mobile and wearable technology. Better engagement strategies are expected to aid current efforts in bipolar research and clinical care, from the development of new mobile phone apps to providing the right intervention to the right individual at the right moment. Trial Registration: ClinicalTrials.gov NCT03358238; https://clinicaltrials.gov/ct2/show/NCT03358238 (Archived by WebCite at http://www.webcitation.org/6yebuNfz5) Registered Report Identifier: RR1-10.2196/9899 %M 29748160 %R 10.2196/resprot.9899 %U http://www.researchprotocols.org/2018/5/e130/ %U https://doi.org/10.2196/resprot.9899 %U http://www.ncbi.nlm.nih.gov/pubmed/29748160 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 5 %P e120 %T Effectiveness of a Blended Multidisciplinary Intervention for Patients with Moderate Medically Unexplained Physical Symptoms (PARASOL): Protocol for a Cluster Randomized Clinical Trial %A van Westrienen,Paula Elisabeth %A Pisters,Martijn F %A Toonders,Suze AJ %A Gerrits,Marloes %A Veenhof,Cindy %A de Wit,Niek J %+ Department of Health Innovation and Technology, Fontys University of Applied Sciences, Ds Th Fliednerstraat 2, Eindhoven, 5600 AH, Netherlands, 31 641621942, p.e.vanwestrienen@umcutrecht.nl %K medically unexplained physical symptoms %K blended care %K multidisciplinary %K primary care %K intervention %D 2018 %7 08.05.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Medically unexplained physical symptoms are an important health problem in primary care, with a spectrum from mild to chronic. The burden of chronic medically unexplained physical symptoms is substantial for patients, health care professionals, and society. Therefore, early identification of patients with moderate medically unexplained physical symptoms is needed in order to prevent chronicity. The preventive screening of medically unexplained physical symptoms (PRESUME) screening method was developed using data from the electronic medical record of the patients' general practitioner and demonstrated its prognostic accuracy to identify patients with moderate medically unexplained physical symptoms. In the next step, we developed a proactive blended and integrated mental health and physical therapy intervention program (PARASOL) to reduce complaints of moderate medically unexplained physical symptoms, stimulate self-management, and prevent chronicity. Objective: The primary objective of this study is to investigate the effectiveness of the blended PARASOL intervention on the impact of symptoms and quality of life in patients with moderate medically unexplained physical symptoms compared with usual care. Secondary objectives are to study the effect on severity of physical and psychosocial symptoms, general health, physical behavior, illness perception, and self-efficacy in patients with moderate medically unexplained physical symptoms as well as to determine the cost-effectiveness of the program. Methods: This paper presents the study protocol of a multicenter cluster randomized clinical trial. Adult patients with moderate medically unexplained physical symptoms will be identified from electronic medical record data using the PRESUME screening method and proactively recruited for participation in the study. Cluster randomization will be performed at the level of the participating health care centers. In total 248 patients with moderate medically unexplained physical symptoms (124 patients per arm) are needed. The PARASOL intervention is a 12-week blended primary care program consisting of 4 face-to-face consultations with the mental health nurse and 5 physical therapy sessions, supplemented with a Web-based program. The Web-based program contains (1) information modules and videos on self-management and educative themes, (2) videos and instructions on prescribed home exercises, and (3) assignments to gradually increase the physical activity. The program is directed at patients’ perception of symptoms as well as modifiable prognostic risk factors for chronicity using therapeutic neuroscience education. It encourages self-management, as well as an active lifestyle using a cognitive behavioral approach and graded activity. Primary outcomes are impact of symptoms and quality of life. Secondary outcomes are severity of physical and psychosocial symptoms, general health, physical behavior, illness perceptions, self-efficacy, and cost-effectiveness. All measurements will be performed at baseline, 3 and 12 months after baseline. Retrospective cost questionnaires will also be sent at 6 and 9 months after baseline and these will be used for the cost-effectiveness analysis. Results: The intervention has been developed, and the physical therapists and mental health nurses in the participating experimental health care centers have received two days of training on the content of the blended PARASOL intervention. The recruitment of health care centers started in June 2016 and inclusion of patients began in March 2017. Follow-up assessments of patients are expected to be completed in March 2019. Conclusions: This study is the first randomized clinical trial to determine the effectiveness (including cost-effectiveness) of a proactive, blended, and integrated mental health and physical therapy care program for patients with moderate medically unexplained physical symptoms. The findings will help to improve the treatment for patients with moderate medically unexplained physical symptoms and prevent chronicity. Trial Registration: Netherlands Trial Register NTR6755; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6755 (Archived by WebCite at http://www.webcitation.org/6ywporY7u). %M 29739735 %R 10.2196/resprot.9404 %U http://www.researchprotocols.org/2018/5/e120/ %U https://doi.org/10.2196/resprot.9404 %U http://www.ncbi.nlm.nih.gov/pubmed/29739735 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 5 %P e98 %T The Detroit Young Adult Asthma Project: Proposal for a Multicomponent Technology Intervention for African American Emerging Adults With Asthma %A MacDonell,Karen %A Naar,Sylvie %A Gibson-Scipio,Wanda %A Bruzzese,Jean-Marie %A Wang,Bo %A Brody,Aaron %+ Department of Family Medicine and Public Health Sciences, Wayne State University, iBio 6135 Woodward Avenue, Behavioral Health, H206, Detroit, MI, 48202, United States, 1 3135776996, karen.macdonell@wayne.edu %K asthma %K telemedicine %K medication adherence %K young adults %K health equity %D 2018 %7 07.05.2018 %9 Proposal %J JMIR Res Protoc %G English %X Background: Racial and ethnic minority youth have poorer asthma status than white youth, even after controlling for socioeconomic variables. Proper use of asthma controller medications is critical in reducing asthma mortality and morbidity. The clinical consequences of poor asthma management include increased illness complications, excessive functional morbidity, and fatal asthma attacks. There are significant limitations in research on interventions to improve asthma management in racial minority populations, particularly minority adolescents and young adults, although illness management tends to deteriorate after adolescence during emerging adulthood, the unique developmental period beyond adolescence but before adulthood. Objective: The objective of the pilot study was to test the feasibility, acceptability, and signals of efficacy of an intervention targeting adherence to controller medication in African American youth (ages 18-29) with asthma. All elements of the protocol were piloted in a National Heart, Lung, and Blood Institute (NHLBI)–funded pilot study (1R34HL107664 MacDonell). Results suggested feasibility and acceptability of the protocol as well as proof of concept. We are now ready to test the intervention in a larger randomized clinical trial. Methods: The proposed study will include 192 African American emerging adults with moderate to severe persistent asthma and low controller medication adherence recruited from clinic, emergency department, and community settings. Half of the sample will be randomized to receive a multicomponent technology-based intervention targeting adherence to daily controller medication. The multicomponent technology-based intervention consists of 2 components: (1) 2 sessions of computer-delivered motivational interviewing targeting medication adherence and (2) individualized text messaging focused on medication adherence between the sessions. Text messages will be individualized based on ecological momentary assessment. The remaining participants will complete a series of computer-delivered asthma education modules matched for length, location, and method of delivery of the intervention session. Control participants will also receive text messages between intervention sessions. Message content will be the same for all control participants and contain general facts about asthma (not tailored). Results: It is hypothesized that youth randomized to multicomponent technology-based intervention will show improvements in medication adherence (primary outcome) and asthma control (secondary outcome) compared with comparison condition at all postintervention follow-ups (3, 6, 9, and 12 months). The proposed study was funded by NHLBI from September 1, 2016 through August 31, 2021. Conclusions: This project will test a brief, technology-based intervention specifically targeting adherence to asthma controller medications in an under-researched population, African American emerging adults. If successful, our multicomponent technology-based intervention aimed at improving adherence to asthma medications has the potential to improve quality of life of minority emerging adults with asthma at relatively low cost. It could eventually be integrated into clinical settings and practice to reach a large number of emerging adults with asthma. Trial Registration: ClinicalTrials.gov NCT03121157; https://clinicaltrials.gov/ct2/show/NCT03121157 (Archived by WebCite at http://www.webcitation.org/6wq4yWHPv) %M 29735474 %R 10.2196/resprot.8872 %U http://www.researchprotocols.org/2018/5/e98/ %U https://doi.org/10.2196/resprot.8872 %U http://www.ncbi.nlm.nih.gov/pubmed/29735474 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 4 %P e107 %T A Web-Based Decision Tool to Improve Contraceptive Counseling for Women With Chronic Medical Conditions: Protocol For a Mixed Methods Implementation Study %A Wu,Justine P %A Damschroder,Laura J %A Fetters,Michael D %A Zikmund-Fisher,Brian J %A Crabtree,Benjamin F %A Hudson,Shawna V %A Ruffin IV,Mack T %A Fucinari,Juliana %A Kang,Minji %A Taichman,L Susan %A Creswell,John W %+ Department of Family Medicine, University of Michigan, 1018 Fuller Street, Ann Arbor, MI, 48103, United States, 1 998 7120, justinep@med.umich.edu %K contraception %K mobile apps %K birth control %K primary care physicians %K implementation science %K decision support techniques %K chronic disease %K multiple chronic conditions %K qualitative research %D 2018 %7 18.04.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Women with chronic medical conditions, such as diabetes and hypertension, have a higher risk of pregnancy-related complications compared with women without medical conditions and should be offered contraception if desired. Although evidence based guidelines for contraceptive selection in the presence of medical conditions are available via the United States Medical Eligibility Criteria (US MEC), these guidelines are underutilized. Research also supports the use of decision tools to promote shared decision making between patients and providers during contraceptive counseling. Objective: The overall goal of the MiHealth, MiChoice project is to design and implement a theory-driven, Web-based tool that incorporates the US MEC (provider-level intervention) within the vehicle of a contraceptive decision tool for women with chronic medical conditions (patient-level intervention) in community-based primary care settings (practice-level intervention). This will be a 3-phase study that includes a predesign phase, a design phase, and a testing phase in a randomized controlled trial. This study protocol describes phase 1 and aim 1, which is to determine patient-, provider-, and practice-level factors that are relevant to the design and implementation of the contraceptive decision tool. Methods: This is a mixed methods implementation study. To customize the delivery of the US MEC in the decision tool, we selected high-priority constructs from the Consolidated Framework for Implementation Research and the Theoretical Domains Framework to drive data collection and analysis at the practice and provider level, respectively. A conceptual model that incorporates constructs from the transtheoretical model and the health beliefs model undergirds patient-level data collection and analysis and will inform customization of the decision tool for this population. We will recruit 6 community-based primary care practices and conduct quantitative surveys and semistructured qualitative interviews with women who have chronic medical conditions, their primary care providers (PCPs), and clinic staff, as well as field observations of practice activities. Quantitative survey data will be summarized with simple descriptive statistics and relationships between participant characteristics and contraceptive recommendations (for PCPs), and current contraceptive use (for patients) will be examined using Fisher exact test. We will conduct thematic analysis of qualitative data from interviews and field observations. The integration of data will occur by comparing, contrasting, and synthesizing qualitative and quantitative findings to inform the future development and implementation of the intervention. Results: We are currently enrolling practices and anticipate study completion in 15 months. Conclusions: This protocol describes the first phase of a multiphase mixed methods study to develop and implement a Web-based decision tool that is customized to meet the needs of women with chronic medical conditions in primary care settings. Study findings will promote contraceptive counseling via shared decision making and reflect evidence-based guidelines for contraceptive selection. Trial Registration: ClinicalTrials.gov NCT03153644; https://clinicaltrials.gov/ct2/show/NCT03153644 (Archived by WebCite at http://www.webcitation.org/6yUkA5lK8) %M 29669707 %R 10.2196/resprot.9249 %U http://www.researchprotocols.org/2018/4/e107/ %U https://doi.org/10.2196/resprot.9249 %U http://www.ncbi.nlm.nih.gov/pubmed/29669707 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 4 %P e84 %T A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial %A Wang,Penny %A Luo,Dee %A Lu,Fengxin %A Elias,Josephine S %A Landman,Adam B %A Michaud,Kaleb D %A Lee,Yvonne C %+ Division of Rheumatology, Department of Medicine, Northwestern University Feinberg School of Medicine, Suite M-300, 240 East Huron Street, Chicago, IL, 60611, United States, 1 312 503 1960, yvonne.lee@northwestern.edu %K arthritis, rheumatoid %K symptom flare up %K telemedicine %K mobile applications %D 2018 %7 11.04.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Rheumatoid arthritis flares have a profound effect on patients, causing pain and disability. However, flares often occur between regularly scheduled health care provider visits and are, therefore, difficult to monitor and manage. We sought to develop a mobile phone app combined with a population management system to help track RA flares between visits. Objective: The objective of this study is to implement the mobile app plus the population management system to monitor rheumatoid arthritis disease activity between scheduled health care provider visits over a period of 6 months. Methods: This is a randomized controlled trial that lasts for 6 months for each participant. We aim to recruit 190 patients, randomized 50:50 to the intervention group versus the control group. The intervention group will be assigned the mobile app and be prompted to answer daily questionnaires sent to their mobile devices. Both groups will be assigned a population manager, who will communicate with the participants via telephone at 6 weeks and 18 weeks. The population manager will also communicate with the participants in the intervention group if their responses indicate a sustained increase in rheumatoid arthritis disease activity. To assess patient satisfaction, the primary outcomes will be scores on the Treatment Satisfaction Questionnaire for Medication as well as the Perceived Efficacy in Patient-Physician Interactions questionnaire at 6 months. To determine the effect of the mobile app on rheumatoid arthritis disease activity, the primary outcome will be the Clinical Disease Activity Index at 6 months. Results: The trial started in November 2016, and an estimated 2.5 years will be necessary to complete the study. Study results are expected to be published by the end of 2019. Conclusions: The completion of this study will provide important data regarding the following: (1) the assessment of validated outcome measures to assess rheumatoid arthritis disease activity with a mobile app between routinely scheduled health care provider visits, (2) patient engagement in monitoring their condition, and (3) communication between patients and health care providers through the population management system. Trial Registration: ClinicalTrials.gov NCT02822521, http://clinicaltrials.gov/ct2/show/NCT02822521 (Archived by WebCite at http://www.webcitation.org/6xed3kGPd) %M 29643053 %R 10.2196/resprot.8771 %U http://www.researchprotocols.org/2018/4/e84/ %U https://doi.org/10.2196/resprot.8771 %U http://www.ncbi.nlm.nih.gov/pubmed/29643053 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 3 %P e76 %T Evaluation of an Internet-Based Behavioral Intervention to Improve Psychosocial Health Outcomes in Children With Insomnia (Better Nights, Better Days): Protocol for a Randomized Controlled Trial %A Corkum,Penny V %A Reid,Graham J %A Hall,Wendy A %A Godbout,Roger %A Stremler,Robyn %A Weiss,Shelly K %A Gruber,Reut %A Witmans,Manisha %A Chambers,Christine T %A Begum,Esmot Ara %A Andreou,Pantelis %A Rigney,Gabrielle %+ Department of Psychology & Neuroscience, Dalhousie University, PO BOX 15000, 1355 Oxford Street, Halifax, NS, B3H 4R2, Canada, 1 902 494 5177, penny.corkum@dal.ca %K sleep %K insomnia %K children %K randomized controlled trial %K eHealth %K Internet %K treatment %D 2018 %7 26.03.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Up to 25% of 1- to 10-year-old children experience insomnia (ie, resisting bedtime, trouble falling asleep, night awakenings, and waking too early in the morning). Insomnia can be associated with excessive daytime sleepiness and negative effects on daytime functioning across multiple domains (eg, behavior, mood, attention, and learning). Despite robust evidence supporting the effectiveness of behavioral treatments for insomnia in children, very few children with insomnia receive these treatments, primarily due to a shortage of available treatment resources. Objective: The Better Nights, Better Days (BNBD) internet-based program provides a readily accessible electronic health (eHealth) intervention to support parents in providing evidence-based care for insomnia in typically developing children. The purpose of the randomized controlled trial (RCT) is to evaluate the effectiveness of BNBD in treating insomnia in children aged between 1 and 10 years. Methods: BNBD is a fully automated program, developed based on evidence-based interventions previously tested by the investigators, as well as on the extant literature on this topic. We describe the 2-arm RCT in which participants (500 primary caregivers of children with insomnia residing in Canada) are assigned to intervention or usual care. Results: The effects of this behavioral sleep eHealth intervention will be assessed at 4 and 8 months postrandomization. Assessment includes both sleep (actigraphy, sleep diary) and daytime functioning of the children and daytime functioning of their parents. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials statement. Conclusions: If the intervention is supported by the results of the RCT, we plan to commercialize this program so that it is sustainable and available at a low cost to all families with internet access. Trial Registration: ClinicalTrials.gov NCT02243501; https://clinicaltrials.gov/show/NCT02243501 (Archived by WebCite at http://www.webcitation.org/6x8Z5pBui) %M 29581089 %R 10.2196/resprot.8348 %U http://www.researchprotocols.org/2018/3/e76/ %U https://doi.org/10.2196/resprot.8348 %U http://www.ncbi.nlm.nih.gov/pubmed/29581089 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 3 %P e77 %T Strengths-Based Behavioral Intervention for Parents of Adolescents With Type 1 Diabetes Using an mHealth App (Type 1 Doing Well): Protocol for a Pilot Randomized Controlled Trial %A Hilliard,Marisa E %A Eshtehardi,Sahar S %A Minard,Charles G %A Saber,Rana %A Thompson,Debbe %A Karaviti,Lefkothea P %A Rojas,Yuliana %A Anderson,Barbara J %+ Section of Psychology, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, 1102 Bates Avenue, Suite 940, Houston, TX, 770030, United States, 1 832 824 7209, marisa.hilliard@bcm.edu %K adolescence %K type 1 diabetes %K parenting %D 2018 %7 13.03.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Supportive parent involvement for adolescents’ type 1 diabetes (T1D) self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. Objective: The aim of this protocol was to describe the development of a new, strengths-based behavioral intervention for parents of adolescents with T1D delivered via a mobile-friendly Web app called Type 1 Doing Well. Methods: Ten adolescent-parent dyads and 5 diabetes care providers participated in a series of qualitative interviews to inform the design of the app. The 3- to 4-month pilot intervention will involve 82 parents receiving daily prompts to use the app, in which they will mark the diabetes-related strength behaviors (ie, positive attitudes or behaviors related to living with or managing T1D) their teen engaged in that day. Parents will also receive training on how to observe diabetes strengths and how to offer teen-friendly praise via the app. Each week, the app will generate a summary of the teen’s most frequent strengths from the previous week based on parent reports, and parents will be encouraged to praise their teen either in person or from a library of reinforcing text messages (short message service, SMS). Results: The major outcomes of this pilot study will include intervention feasibility and satisfaction data. Clinical and behavioral outcomes will include glycemic control, regimen adherence, family relationships and conflict, diabetes burden, and health-related quality of life. Conclusions: This strengths-based, mobile health (mHealth) intervention aims to help parents increase their awareness of and efforts to support their adolescents’ engagement in positive diabetes-related behaviors. If efficacious, this intervention has the potential to reduce the risk of family conflict, enhance collaborative family teamwork, and ultimately improve diabetes outcomes. Trial Registration: ClinicalTrials.gov NCT02877680; https://clinicaltrials.gov/ct2/show/NCT02877680 (Archived by WebCite at http://www.webcitation.org/6xTAMN5k2) %M 29535081 %R 10.2196/resprot.9147 %U http://www.researchprotocols.org/2018/3/e77/ %U https://doi.org/10.2196/resprot.9147 %U http://www.ncbi.nlm.nih.gov/pubmed/29535081 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 3 %P e59 %T Improving Transplant Medication Safety Through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention: TRANSAFE Rx Study Protocol %A Fleming,James N %A Treiber,Frank %A McGillicuddy,John %A Gebregziabher,Mulugeta %A Taber,David J %+ Department of Pharmacy, Medical University of South Carolina, 150 Ashley Avenue, Charleston, SC, 29414, United States, 1 843 792 5868, fleminj@musc.edu %K telemedicine %K mhealth %K transplant %K clinical trial %K errors %K adherence %D 2018 %7 02.03.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Medication errors, adverse drug events, and nonadherence are the predominant causes of graft loss in kidney transplant recipients and lead to increased healthcare utilization. Research has demonstrated that clinical pharmacists have the unique education and training to identify these events early and develop strategies to mitigate or prevent downstream sequelae. In addition, studies utilizing mHealth interventions have demonstrated success in improving the control of chronic conditions that lead to kidney transplant deterioration. Objective: The goal of the prospective, randomized TRANSAFE Rx study is to measure the clinical and economic effectiveness of a pharmacist-led, mHealth-based intervention, as compared to usual care, in kidney transplant recipients. Methods: TRANSAFE Rx is a 12-month, parallel, two-arm, 1:1 randomized controlled clinical trial involving 136 participants (68 in each arm) and measuring the clinical and economic effectiveness of a pharmacist-led intervention which utilizes an innovative mobile health application to improve medication safety and health outcomes, as compared to usual posttransplant care. Results: The primary outcome measure of this study will be the incidence and severity of MEs and ADRs, which will be identified, categorized, and compared between the intervention and control cohorts. The exploratory outcome measures of this study are to compare the incidence and severity of acute rejections, infections, graft function, graft loss, and death between research cohorts and measure the association between medication safety issues and these events. Additional data that will be gathered includes sociodemographics, health literacy, depression, and support. Conclusions: With this report we describe the study design, methods, and outcome measures that will be utilized in the ongoing TRANSAFE Rx clinical trial. Trial Registration: ClinicalTrials.gov NCT03247322: https://clinicaltrials.gov/ct2/show/NCT03247322 (Archived by WebCite at http://www.webcitation.org/6xcSUnuzW) %M 29500161 %R 10.2196/resprot.9078 %U https://www.researchprotocols.org/2018/3/e59/ %U https://doi.org/10.2196/resprot.9078 %U http://www.ncbi.nlm.nih.gov/pubmed/29500161 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 2 %P e60 %T Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial %A Cox,Vincent CM %A Schepers,Vera PM %A Ketelaar,Marjolijn %A van Heugten,Caroline M %A Visser-Meily,Johanna MA %+ Center of Excellence in Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht University and De Hoogstraat Rehabilitation, Heidelberglaan 100, Utrecht, 3584 CX, Netherlands, 31 887558831, V.P.M.Schepers@umcutrecht.nl %K caregivers %K brain injuries %K internet %K telemedicine %K randomized controlled trial %D 2018 %7 16.02.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Support programs for partners of patients with acquired brain injury are necessary since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psychoeducation, skill building, problem solving, and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. Objective: This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. Methods: A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. Results: The effect of the intervention on the primary and secondary outcome measures will be determined. Additional a process evaluation will be conducted. Conclusions: The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. Trial Registration: Dutch Trial Register NTR6197; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197 (Archived by WebCite at http://www.webcitation.org/6xHBAxx0y) %M 29453189 %R 10.2196/resprot.9108 %U http://www.researchprotocols.org/2018/2/e60/ %U https://doi.org/10.2196/resprot.9108 %U http://www.ncbi.nlm.nih.gov/pubmed/29453189 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 2 %P e27 %T Increasing Physical Activity Amongst Overweight and Obese Cancer Survivors Using an Alexa-Based Intelligent Agent for Patient Coaching: Protocol for the Physical Activity by Technology Help (PATH) Trial %A Hassoon,Ahmed %A Schrack,Jennifer %A Naiman,Daniel %A Lansey,Dina %A Baig,Yasmin %A Stearns,Vered %A Celentano,David %A Martin,Seth %A Appel,Lawrence %+ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 615 N Wolfe Street, E6035, Baltimore, MD, 21205, United States, 1 443 287 2775, ahassoo1@jhu.edu %D 2018 %7 12.02.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Physical activity has established health benefits, but motivation and adherence remain challenging. Objective: We designed and launched a three-arm randomized trial to test artificial intelligence technology solutions to increase daily physical activity in cancer survivors. Methods: A single-center, three-arm randomized clinical trial with an allocation ration of 1:1:1: (A) control, in which participants are provided written materials about the benefits of physical activity; (B) text intervention, where participants receive daily motivation from a fully automated, data-driven algorithmic text message via mobile phone (Coachtext); and (C) Voice Assist intervention, where participants are provided with an in-home on demand autonomous Intelligent Agent using data driven Interactive Digital Voice Assist on the Amazon Alexa/Echo (MyCoach). Results: The study runs for 5 weeks: a one-week run-in to establish baseline, followed by 4 weeks of intervention. Data for study outcomes is collected automatically through a wearable sensor, and data are transferred in real-time to the study server. The recruitment goal is 42 participants, 14 in each arm. Electronic health records are used to prescreen candidates, with 39 participants recruited to date. Discussion: This study aims to investigate the effects of different types of intelligent technology solutions on promoting physical activity in cancer survivors. This innovative approach can easily be expanded and customized to other interventions. Early lessons from our initial participants are helping us develop additional advanced solutions to improve health outcomes. Trial Registration: Retrospectively registered on July 10, 2017 at ClinicalTrials.gov: NCT03212079; https://clinicaltrials.gov/ct2/show/NCT03212079 (Archived by WebCite at http://www.webcitation.org/6wgvqjTji) %M 29434016 %R 10.2196/resprot.9096 %U https://www.researchprotocols.org/2018/2/e27/ %U https://doi.org/10.2196/resprot.9096 %U http://www.ncbi.nlm.nih.gov/pubmed/29434016 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 2 %P e40 %T Enhancing Lifestyle Change in Cardiac Patients Through the Do CHANGE System (“Do Cardiac Health: Advanced New Generation Ecosystem”): Randomized Controlled Trial Protocol %A Habibović,Mirela %A Broers,Eva %A Piera-Jimenez,Jordi %A Wetzels,Mart %A Ayoola,Idowu %A Denollet,Johan %A Widdershoven,Jos %+ Department of Medical and Clinical Psychology, Tilburg University, PO Box 90153, Tilburg, 5000 LE, Netherlands, 31 134664020, m.habibovic@tilburguniversity.edu %K cardiac health %K lifestyle %K behavior change %K eHealth %K mHealth %D 2018 %7 08.02.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Promoting a healthy lifestyle (eg, physical activity, healthy diet) is crucial for the primary and secondary prevention of cardiac disease in order to decrease disease burden and mortality. Objective: The current trial aims to evaluate the effectiveness of the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) service, which is developed to assist cardiac patients in adopting a healthy lifestyle and improving their quality of life. Methods: Cardiac patients (ie, people who have been diagnosed with heart failure, coronary artery disease, and/or hypertension) will be recruited at three pilot sites (Badalona Serveis Assistencials, Badalona, Spain [N=75]; Buddhist Tzu Chi Dalin General Hospital, Dalin, Taiwan [N=100] and Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands [N=75]). Patients will be assisted by the Do Something Different (DSD) program to change their unhealthy habits and/or lifestyle. DSD has been developed to increase behavioral flexibility and subsequently adopt new (healthier) habits. In addition, patients’ progress will be monitored with a number of (newly developed) devices (eg, Fitbit, Beddit, COOKiT, FLUiT), which will be integrated in one application. Results: The Do CHANGE trial will provide us with new insights regarding the effectiveness of the proposed intervention in different cultural settings. In addition, it will give insight into what works for whom and why. Conclusions: The Do CHANGE service integrates new technologies into a behavior change intervention in order to change the unhealthy lifestyles of cardiac patients. The program is expected to facilitate long-term, sustainable behavioral change. Trial Registration: Clinicaltrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305 (Archived by WebCite at http://www.webcitation.org/6wfWHvuyU). %M 29422454 %R 10.2196/resprot.8406 %U http://www.researchprotocols.org/2018/2/e40/ %U https://doi.org/10.2196/resprot.8406 %U http://www.ncbi.nlm.nih.gov/pubmed/29422454 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 2 %P e37 %T Text-Based Program Addressing the Mental Health of Soon-to-be and New Fathers (SMS4dads): Protocol for a Randomized Controlled Trial %A Fletcher,Richard %A May,Chris %A Attia,John %A Garfield,Craig Franklin %A Skinner,Geoff %+ Family Action Centre, Faculty of Health and Medicine, University of Newcastle, Academic Office Block, University Drive, Callaghan, 2308, Australia, 61 0429152405, richard.fletcher@newcastle.edu.au %K perinatal %K fathers %K online intervention %K randomized controlled trial %K mental health %D 2018 %7 06.02.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Recent estimates indicating that approximately 10% of fathers experience Paternal Perinatal Depression (PPND) and the increasing evidence of the impact of PPND on child development suggest that identifying and assisting distressed fathers is justified on public health grounds. However, addressing new fathers’ mental health needs requires overcoming men’s infrequent contact with perinatal health services and their reluctance to seek help. Text-based interventions delivering information and support have the potential to reach such groups in order to reduce the impact of paternal perinatal distress and to improve the wellbeing of their children. While programs utilising mobile phone technology have been developed for mothers, fathers have not been targeted. Since text messages can be delivered to individual mobile phones to be accessed at a time that is convenient, it may provide a novel channel for engaging with “hard-to-reach” fathers in a critical period of their parenting. Objective: The study will test the efficacy of SMS4dads, a text messaging program designed specifically for fathers including embedded links to online information and regular invitations (Mood Tracker) to monitor their mood, in order to reduce self-reported depression, anxiety and stress over the perinatal period. Methods: A total of 800 fathers-to-be or new fathers from within Australia will be recruited via the SMS4dads website and randomized to the intervention or control arm. The intervention arm will receive 14 texts per month addressing fathers’ physical and mental health, their relationship with their child, and coparenting with their partner. The control, SMS4health, delivers generic health promotion messages twice per month. Messages are timed according to the babies’ expected or actual date of birth and fathers can enroll from 16 weeks into the pregnancy until their infant is 12 weeks of age. Participants complete questionnaires assessing depression, anxiety, stress, and alcohol at baseline and 24 weeks postenrolment. Measures of coparenting and parenting confidence are also completed at baseline and 24 weeks for postbirth enrolments. Results: Participant were recruited between October 2016 and September 2017. Follow-up data collection has commenced and will be completed in March 2018 with results expected in June 2018. Conclusions: This study’s findings will assess the efficacy of a novel text-based program specifically targeting fathers in the perinatal period to improve their depression, anxiety and distress symptoms, coparenting quality, and parenting self-confidence. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000261415; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=370085 (Archived by WebCite at http://www.webcitation.org/6wav55wII). %M 29410387 %R 10.2196/resprot.8368 %U http://www.researchprotocols.org/2018/2/e37/ %U https://doi.org/10.2196/resprot.8368 %U http://www.ncbi.nlm.nih.gov/pubmed/29410387 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 1 %P e35 %T The Effectiveness and Cost-Effectiveness of Web-Based and Home-Based Postnatal Psychoeducational Interventions for First-Time Mothers: Randomized Controlled Trial Protocol %A He,Honggu %A Zhu,Lixia %A Chan,Sally Wai Chi %A Chong,Yap-Seng %A Jiao,Nana %A Chan,Yiong Huak %A Luo,Nan %A Shorey,Shefaly %+ Alice Lee Centre for Nursing Studies, National University of Singapore, Level 2 Clinical Research Centre, Block MD 11, 10 Medical Drive, Singapore, 117597, Singapore, 65 66011294 ext 1294, nurssh@nus.edu.sg %K mothers %K education %K postpartum period %K Internet %D 2018 %7 31.01.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: In addition to recuperating from the physical and emotional demands of childbirth, first-time mothers are met with demands of adapting to their social roles while picking up new skills to take care of their newborn. Mothers may not feel adequately prepared for parenthood if they are situated in an unsupported environment. Postnatal psychoeducational interventions have been shown to be useful and can offer a cost-effective solution for improving maternal outcomes. Objective: The objective of this study was to examine the effectiveness and cost-effectiveness of Web-based and home-based postnatal psychoeducational programs for first-time mothers on maternal outcomes. Methods: A randomized controlled three-group pre- and posttests experimental design is proposed. This study plans to recruit 204 first-time mothers on their day of discharge from a public tertiary hospital in Singapore. Eligible first-time mothers will be randomly allocated to either a Web-based psychoeducation group, a home-based psychoeducation group, or a control group receiving standard care. The outcomes include maternal parental self-efficacy, social support, psychological well-being (anxiety and postnatal depression), and cost evaluation. Data will be collected at baseline, 1 month, 3 months, and 6 months post-delivery. Results: The recruitment (n=204) commenced in October 2016 and was completed in February 2017, with 68 mothers in each group. The 6-month follow-up data collection was completed in August 2017. Conclusions: This study may identify an effective and cost-effective Web-based postnatal psychoeducational program to improve first-time mothers’ health outcomes. The provision of a widely-accessed Web-based postnatal psychoeducational program will eventually lead to more positive postnatal experiences for first-time mothers and positively influence their future birth plans. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 45202278; http://www.isrctn.com/ISRCTN45202278 (Archived by WebCite at http://www.webcitation.org/6whx0pQ2F). %M 29386175 %R 10.2196/resprot.9042 %U http://www.researchprotocols.org/2018/1/e35/ %U https://doi.org/10.2196/resprot.9042 %U http://www.ncbi.nlm.nih.gov/pubmed/29386175 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 1 %P e8 %T Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial %A Ball,Elizabeth %A Newton,Sian %A Kahan,Brennan C %A Forbes,Gordon %A Wright,Neil %A Cantalapiedra Calvete,Clara %A Gibson,Harry A L %A Rogozinska,Ewelina %A Rivas,Carol %A Taylor,Stephanie J C %A Birch,Judy %A Dodds,Julie %+ Department of Obstetrics and Gynaecology, Barts Health NHS Trust, Royal London Hospital, Whitechapel Road, London, E1 1BB, United Kingdom, 44 20 7377 7000, Elizabeth.ball@bartshealth.nhs.uk %K randomized controlled trial %K pelvic pain %K chronic pain %K mobile applications %K mindfulness %K meditation %D 2018 %7 15.01.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app. Objective: To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app. Methods: Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance. Results: Recruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26, 2017. Conclusions: This feasibility trial will inform the design of a large multicentered trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP. Trial Registration: ClinicalTrials.gov: NCT02721108; https://clinicaltrials.gov/ct2/show/NCT02721108 (Archived by WebCite at http://www.webcitation.org/6wLMAkuaU); BioMed Central: ISRCTN10925965; https://www.isrctn.com/ISRCTN10925965 (Archived by WebCite at http://www.webcitation.org/6wLMVLuys) %M 29335232 %R 10.2196/resprot.7720 %U http://www.researchprotocols.org/2018/1/e8/ %U https://doi.org/10.2196/resprot.7720 %U http://www.ncbi.nlm.nih.gov/pubmed/29335232 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 1 %P e5 %T A Shared Decision-Making Tool to Prevent Substance Abuse: Protocol for a Randomized Controlled Trial %A Long,Ju %A Yuan,Juntao Michael %A Johnson,Ron Kim %+ Department of Computer Information Systems and Quantitative Methods, McCoy College of Business, Texas State University, McCoy 404, 601 University Dr, San Marcos, TX,, United States, 1 512 245 3231, jl38@txstate.edu %K SBIRT %K substance abuse %K SUD %K primary care brief intervention %D 2018 %7 11.01.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Substance use disorder (SUD) affects over 20 million adults and costs over $700 billion annually in the United States. It is one the greatest health care challenges we face. Objective: This research project seeks to enhance the standard practice of Screening, Brief Intervention, and Referral to Treatment (SBIRT) through a mobile solution easily incorporated into primary care that will promote shared decision making and increase referral and adherence to specialty care through continued follow-up care. Methods: This research will conduct an Office of Management and Budget (OMB)–approved randomized controlled trial (RCT) in primary care and SUD specialty service providers. The RCT will recruit a total of 500 SUD patients. Recruited patients will be randomized into control and intervention arms. Both arms will take initial baseline and exit (30 days) surveys to evaluate self-reported substance use and specialty service utilization. The control arm patients will receive usual care. The intervention group patients will receive technology-enhanced SBIRT and a mobile follow-up program to track goals and substance use at home. The RCT tracks participants for 30 days after the primary care encounter. We will collect feedback from the patients during the 30 days and count the number of patients who use specialty care services in specialty care programs for tobacco, alcohol, and drug abuse (both from self-reporting and from the service providers). Results: RCT and data collection are underway. We expect to report the data results in 2018. Conclusions: We expect that significantly more intervention group patients will receive specialty SUD care within 30 days following the SBIRT encounter at the primary care clinic compared to the control group. We also expect that the intervention group patients will report a greater reduction in substance use and a greater drop in Drug Abuse Screening Test and Addition Severity Index scores within 30 days. %M 29326094 %R 10.2196/resprot.7650 %U http://www.researchprotocols.org/2018/1/e5/ %U https://doi.org/10.2196/resprot.7650 %U http://www.ncbi.nlm.nih.gov/pubmed/29326094 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 12 %P e244 %T The Effectiveness of Text Messaging for Detection and Management of Hypertension in Indigenous People in Canada: Protocol for a Randomized Controlled Trial %A Yeates,Karen %A Campbell,Norm %A Maar,Marion A %A Perkins,Nancy %A Liu,Peter %A Sleeth,Jessica %A Smith,Carter %A McAllister,Colin %A Hua-Stewart,Diane %A Wells,George %A Tobe,Sheldon W %+ Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Department of Medicine, University of Toronto, 1929 Bayview Avenue Room 380, Toronto, ON,, Canada, 1 416 616 7043, sheldon.tobe@sunnybrook.ca %K hypertension %K health services, indigenous %K chronic disease %K disease management %K telemedicine %K text messaging %D 2017 %7 19.12.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension, the leading cause of morbidity and mortality, affects more than 1 billion people and is responsible globally for 10 million deaths annually. Hypertension can be controlled on a national level; in Canada, for example, awareness, treatment, and control improved dramatically from only 16% in 1990 to 66% currently. The ongoing development, dissemination, and implementation of Hypertension Canada’s clinical practice guidelines is considered to be responsible, in part, for achieving these high levels of control and the associated improvements in cardiovascular outcomes. A gap still exists between the evidence and the implementation of hypertension guidelines in Indigenous communities in Canada, as well as in low- and middle-income countries (LMICs). The rapid rise in the ownership and use of mobile phones globally and the potential for texting (short message service, SMS) to improve health literacy and to link the health team together with the patient served as a rationale for the Dream-Global study in both Canada and Tanzania. Objective: The primary objective of the Dream-Global study is to assess the effect of innovative technologies and changes in health services delivery on blood pressure (BP) control of Indigenous people in Canada and rural Tanzanians with hypertension using SMS messages and community BP measurement through task shifting with transfer of the measures electronically to the patient and the health care team members. Methods: This prospective, randomized blinded allocation study enrolls both adults with uncontrolled hypertension (medicated or unmedicated) and those without hypertension but at high risk of developing this condition who participate in a BP screening study. Participants will be followed for at least 12 months. Results: The primary efficacy endpoint in this study will be assessed by analysis of variance. Descriptive data will be given with the mean and standard deviation for continuous data and proportions for ordinal data. Exploratory subgroup analyses will include analysis by community, sex, mobile phone ownership at baseline, and age. The knowledge gained from the text messages will be assessed using a questionnaire at study completion, and results will be compared between the groups. Conclusions: This study is expected to provide insights into the implementation of an innovative system of guidelines- and community-based treatment and follow-up for hypertension in Indigenous communities in Canada and in Tanzania, an example of an LMIC. These insights are expected to provide the information needed to plan scalable and sustainable interventions to control BP virtually anywhere in the world. Trial Registration: Clinicaltrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6v7IdYzZh) %M 29258978 %R 10.2196/resprot.7139 %U http://www.researchprotocols.org/2017/12/e244/ %U https://doi.org/10.2196/resprot.7139 %U http://www.ncbi.nlm.nih.gov/pubmed/29258978 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 12 %P e231 %T Direct to Public Peer Support and e-Therapy Program Versus Information to Aid Self-Management of Depression and Anxiety: Protocol for a Randomized Controlled Trial %A Kaylor-Hughes,Catherine J %A Rawsthorne,Mat %A Coulson,Neil S %A Simpson,Sandra %A Simons,Lucy %A Guo,Boliang %A James,Marilyn %A Moran,Paul %A Simpson,Jayne %A Hollis,Chris %A Avery,Anthony J %A Tata,Laila J %A Williams,Laura %A , %A Morriss,Richard K %+ National Institute for Health Research: Collaboration for Leadership in Applied Health Research and Care East Midlands, University of Nottingham, Institute of Mental Health Building, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 01158232478, richard.morriss@nottingham.ac.uk %K depression %K anxiety %K peer support %K online %K self-management %D 2017 %7 18.12.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Regardless of geography or income, effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe, anonymized public health–driven Web-based services such as Big White Wall (BWW), which offer immediate peer support at low cost. Objective: Using Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) methodology, the aim of this study was to determine the population reach, effectiveness, cost-effectiveness, and barriers and drivers to implementation of BWW compared with Web-based information compiled by UK’s National Health Service (NHS, NHS Choices Moodzone) in people with probable mild to moderate depression and anxiety disorder. Methods: A pragmatic, parallel-group, single-blind randomized controlled trial (RCT) is being conducted using a fully automated trial website in which eligible participants are randomized to receive either 6 months access to BWW or signposted to the NHS Moodzone site. The recruitment of 2200 people to the study will be facilitated by a public health engagement campaign involving general marketing and social media, primary care clinical champions, health care staff, large employers, and third sector groups. People will refer themselves to the study and will be eligible if they are older than 16 years, have probable mild to moderate depression or anxiety disorders, and have access to the Internet. Results: The primary outcome will be the Warwick-Edinburgh Mental Well-Being Scale at 6 weeks. We will also explore the reach, maintenance, cost-effectiveness, and barriers and drivers to implementation and possible mechanisms of actions using a range of qualitative and quantitative methods. Conclusions: This will be the first fully digital trial of a direct to public online peer support program for common mental disorders. The potential advantages of adding this to current NHS mental health services and the challenges of designing a public health campaign and RCT of two digital interventions using a fully automated digital enrollment and data collection process are considered for people with depression and anxiety. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 12673428; http://www.controlled-trials.com/ISRCTN12673428/12673428 (Archived by WebCite at http://www.webcitation.org/6uw6ZJk5a) %M 29254909 %R 10.2196/resprot.8061 %U http://www.researchprotocols.org/2017/12/e231/ %U https://doi.org/10.2196/resprot.8061 %U http://www.ncbi.nlm.nih.gov/pubmed/29254909 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 12 %P e242 %T Mobile Health Technology (mDiab) for the Prevention of Type 2 Diabetes: Protocol for a Randomized Controlled Trial %A Muralidharan,Shruti %A Mohan,Viswanathan %A Anjana,Ranjit Mohan %A Jena,Sidhant %A Tandon,Nikhil %A Allender,Steven %A Ranjani,Harish %+ Translational Research Department, Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, No 4, Conron Smith Road,, Gopalapuram, Chennai, 600086, India, 91 4443968888, ranjani@mdrf.in %K prevention %K diabetes mellitus, type 2 %K mHealth %D 2017 %7 12.12.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: The prevalence of type 2 diabetes is increasing in epidemic proportions in low- and middle-income countries. There is an urgent need for novel methods to tackle the increasing incidence of diabetes. The ubiquity of mobile phone use and access to Internet makes mobile health (mHealth) technology a viable tool to prevent and manage diabetes. Objective: The objective of this randomized controlled trial is to implement and evaluate the feasibility, cost-effectiveness, and sustainability of a reality television–based lifestyle intervention program. This intervention program is delivered via a mobile phone app (mDiab) to approximately 1500 Android smartphone users who are adults at a high risk for type 2 diabetes from three cities in India, namely, Chennai, Bengaluru, and New Delhi. Methods: The mDiab intervention would be delivered via a mobile phone app along with weekly coach calls for 12 weeks. Each participant will go through a maintenance phase of 6 to 8 months post intervention. Overall, there would be 3 testing time points in the study: baseline, post intervention, and the end of follow-up. The app will enable individuals to track their weight, physical activity, and diet alongside weekly video lessons on type 2 diabetes prevention. Results: The study outcomes are weight loss (primary measure of effectiveness); improvement in cardiometabolic risk factors (ie, waist circumference, blood pressure, glucose, insulin, and lipids); and improvement in physical activity, quality of life, and dietary habits. Sustainability will be assessed through focus group discussions. Conclusions: If successful, mDiab can be used as a model for translational and implementation research in the use of mHealth technology for diabetes prevention and may be further expanded for the prevention of other noncommunicable diseases such as hypertension and cardiovascular diseases. Trial Registration: Clinical Trials Registry of India CTRI/2015/07/006011 http://ctri.nic.in/Clinicaltrials/pdf_generate.php? trialid=11841 (Archived by WebCite at http://www.webcitation.org/6urCS5kMB) %M 29233806 %R 10.2196/resprot.8644 %U http://www.researchprotocols.org/2017/12/e242/ %U https://doi.org/10.2196/resprot.8644 %U http://www.ncbi.nlm.nih.gov/pubmed/29233806 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 12 %P e243 %T Clinic Versus Online Social Network–Delivered Lifestyle Interventions: Protocol for the Get Social Noninferiority Randomized Controlled Trial %A Wang,Monica L %A Waring,Molly E %A Jake-Schoffman,Danielle E %A Oleski,Jessica L %A Michaels,Zachary %A Goetz,Jared M %A Lemon,Stephenie C %A Ma,Yunsheng %A Pagoto,Sherry L %+ Department of Allied Health Sciences, College of Agriculture, Health, and Natural Resources, University of Connecticut, Koons Hall, 358 Mansfield Road, Unit 1101, Storrs, CT, 06269 1101, United States, 1 860 486 2313, sherry.pagoto@uconn.edu %K methods %K randomized controlled trial %K life style %K obesity %K weight loss %K social support %D 2017 %7 11.12.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Although online social networks have been integrated as one component of multimodality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network with a traditional clinic-delivered intervention. Objective: This paper describes the design and methods of a noninferiority randomized controlled trial, testing (1) whether a lifestyle intervention delivered entirely through an online social network would produce weight loss that would not be appreciably worse than that induced by a traditional clinic-based lifestyle intervention among overweight and obese adults and (2) whether the former would do so at a lower cost. Methods: Adults with body mass index (BMI) between 27 and 45 kg/m2 (N=328) will be recruited from the communities in central Massachusetts. These overweight or obese adults will be randomized to two conditions: a lifestyle intervention delivered entirely via the online social network Twitter (Get Social condition) and an in-person group-based lifestyle intervention (Traditional condition) among overweight and obese adults. Measures will be obtained at baseline, 6 months, and 12 months after randomization. The primary noninferiority outcome is percentage weight loss at 12 months. Secondary noninferiority outcomes include dietary intake and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition. Results: The final wave of data collection is expected to conclude in June 2019. Data analysis will take place in the months following and is expected to be complete in September 2019. Conclusions: Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an effective alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models. Trial Registration: ClinicalTrials.gov NCT02646618; https://clinicaltrials.gov/ct2/show/NCT02646618 (Archived by WebCite at http://www.webcitation.org/6v20waTFW) %M 29229591 %R 10.2196/resprot.8068 %U http://www.researchprotocols.org/2017/12/e243/ %U https://doi.org/10.2196/resprot.8068 %U http://www.ncbi.nlm.nih.gov/pubmed/29229591 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 11 %P e241 %T In-Person Versus eHealth Mindfulness-Based Intervention for Adolescents With Chronic Illness: Protocol for a Randomized Controlled Trial %A Chadi,Nicholas %A Kaufman,Miriam %A Weisbaum,Elli %A Malboeuf-Hurtubise,Catherine %A Kohut,Sara Ahola %A Viner,Christine %A Locke,Jake %A Vo,Dzung X %+ Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, 300 Longwood Ave, Boston, MA,, United States, 1 617 355 2727, nicholas.chadi@hotmail.com %K mindfulness %K meditation %K chronic illness %K adolescent %K eHealth %K randomized %K protocol %D 2017 %7 27.11.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Eight-week mindfulness-based interventions (MBIs) have a beneficial impact on mental health and well-being in adolescents with chronic health conditions. Usually delivered in person in a group setting, these programs are difficult to access for teens with disabilities or who do not have in-person MBIs available in their communities. Objective: This paper outlines the rationale, development, and design of a randomized controlled trial comparing the effects of an MBI delivered in person or via eHealth in adolescents with a chronic illness. Quantitative outcomes will include mindfulness skills acquisition (primary outcome), effects of the MBI on self-reported mood, anxiety, self-esteem, illness perception, and physiological stress (via salivary cortisol), and qualitative outcomes will include individual practice, participant appreciation, and adaptation of the MBI for eHealth. Methods: This is a randomized noninferiority mixed methods study comparing 2 MBI arms: in-person and eHealth. Participants are eligible to participate if they are aged 13 to 18 years, have a diagnosis of chronic medical condition, live close enough to the recruitment hospital to participate in the in-person arm of the study, and are currently followed by a health care provider. Each participant will receive an adapted 8-week MBI delivered either in person at a tertiary pediatric hospital or via a secure audio-visual platform allowing group interactions in real time. Groups will be facilitated by 2 experienced mindfulness providers. Quantitative and qualitative data will be collected through standardized research questionnaires administered via a secure, youth-friendly online platform and through semistructured interviews, participant log books, facilitator log books, and salivary cortisol analysis. Qualitative data will be analyzed using a grounded theory model. Results: Data collection is currently underway. Data analysis, manuscript writing, and additional publications are expected to be completed in the winter and spring of 2018. Conclusions: Based on previous results from in-person trials conducted in adolescents and eHealth trials conducted in adults, we anticipate that both modes of delivery will significantly improve mindfulness skills acquisition, mood, anxiety, self-esteem, illness perception, and stress and that the magnitude of the effects will be correlated to the level of home practice. We predict that participants in both arms will show similar levels of home practice and that both modes of delivery will have high levels of feasibility and acceptability. If successful, this study could provide evidence for the use of eHealth in the delivery of 8-week MBIs in clinical adolescent populations, potentially increasing availability to MBIs for a large group of youth with mobility issues or living away from large urban centers. Trial Registration: ClinicalTrials.org NCT03067207; https://clinicaltrials.gov/ct2/show/NCT03067207 (archived by WebCite at http://www.webcitation.org/6v4ZK8RBH) %M 29180345 %R 10.2196/resprot.7700 %U http://www.researchprotocols.org/2017/11/e241/ %U https://doi.org/10.2196/resprot.7700 %U http://www.ncbi.nlm.nih.gov/pubmed/29180345 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 11 %P e229 %T Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol %A Seto,Emily %A Ware,Patrick %A Logan,Alexander G %A Cafazzo,Joseph A %A Chapman,Kenneth R %A Segal,Phillip %A Ross,Heather J %+ Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, 4th Floor, Suite 425, Toronto, ON,, Canada, 1 416 669 9295, emily.seto@utoronto.ca %K mHealth %K smartphone %K multiple chronic diseases %K randomized controlled trial %D 2017 %7 21.11.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chronic conditions, although these patients may benefit the most from this technology. Objective: The aim of this study is to investigate the impact of a smartphone-based telemonitoring system on the clinical care and health outcomes of complex patients across several chronic conditions. Methods: A mixed-methods, 6-month randomized controlled trial (RCT) of a smartphone-based telemonitoring system is being conducted in specialty clinics. The study will include patients who have been diagnosed with one or more of any of the following conditions: heart failure, chronic obstructive pulmonary disease, chronic kidney disease, uncontrolled hypertension, or insulin-requiring diabetes. The primary outcome will be the health status of patients as measured with SF-36. Patients will be randomly assigned to either the control group receiving usual care (n=73) or the group using the smartphone-based telemonitoring system in addition to usual care (n=73). Results: Participants are currently being recruited for the trial. Data collection is anticipated to be completed by the fall of 2018. Conclusions: This RCT will be among the first trials to provide evidence of the impact of telemonitoring on costs and health outcomes of complex patients who may have multiple chronic conditions. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 41238563; http://www.isrctn.com/ISRCTN41238563 (Archived by WebCite at http://www.webcitation.org/6ug2Sk0af) and Clinicaltrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 (Archived by WebCite at http://www.webcitation.org/6uvjNosBC) %M 29162557 %R 10.2196/resprot.8367 %U http://www.researchprotocols.org/2017/11/e229/ %U https://doi.org/10.2196/resprot.8367 %U http://www.ncbi.nlm.nih.gov/pubmed/29162557 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 11 %P e215 %T Improving Transition to Employment for Youth With Physical Disabilities: Protocol for a Peer Electronic Mentoring Intervention %A Lindsay,Sally %A Stinson,Jennifer %A Stergiou-Kita,Mary %A Leck,Joanne %+ Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, ON, M4G 1R8, Canada, 1 4164256220 ext 3654, slindsay@hollandbloorview.ca %K social support %K mentor %K social inclusion %K youth %K disability %K rehabilitation %K occupational therapy %D 2017 %7 16.11.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although youth with disabilities have much to gain from employment readiness programs, they are often excluded from or have limited access to vocational programs. One encouraging approach to address gaps in vocational programming is through peer electronic mentoring (e-mentoring), which may facilitate a smoother transition to adulthood by offering support to enhance coping skills. Despite the increase in online communities, little is known about their impact on vocational mentoring for youth with physical disabilities and their parents. Objective: The aim of this paper is to develop, implement, and assess the feasibility of an online peer mentor employment readiness intervention for youth with physical disabilities and their parents to improve their self-determination, career maturity, and social support compared to controls. Methods: A mixed-methods feasibility randomized controlled trial (RCT) design will be conducted to develop and assess the feasibility, acceptability, and initial efficacy of the “Empowering Youth Towards Employment” intervention. Youth (aged 15 to 25) with physical disabilities and their parents will be randomly assigned to a control or experimental group (4-week, interactive intervention, moderated by peer mentors). Results: Data collection is in progress. Planned analyses include pre-post measures to determine the impact of the intervention on self-determination, career maturity, and social support. A qualitative thematic analysis of the discussion forums will complement the surveys to better understand why certain outcomes may have occurred. Conclusions: Our intervention includes evidence-informed content and was co-created by a multi-disciplinary group of researchers and knowledge users. It has the potential for widespread implications as a cost-effective resource to supplement educational and vocational programming for youth with disabilities. Trial Registration: Clinicaltrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc) %M 29146566 %R 10.2196/resprot.8034 %U http://www.researchprotocols.org/2017/11/e215/ %U https://doi.org/10.2196/resprot.8034 %U http://www.ncbi.nlm.nih.gov/pubmed/29146566 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 10 %P e207 %T Internet-Delivered Dialectical Behavioral Therapy Skills Training for Suicidal and Heavy Episodic Drinkers: Protocol and Preliminary Results of a Randomized Controlled Trial %A Wilks,Chelsey %A Yin,Qingqing %A Ang,Sin Yee %A Matsumiya,Brandon %A Lungu,Anita %A Linehan,Marsha %+ Behavioral Research and Therapy Clinics, Department of Psychology, University of Washington, 3935 University Way, Seattle, WA, 98195, United States, 1 7027156241, wilksc@u.washington.edu %K dialectical behavioral therapy %K randomized controlled trial %K eMental health %K suicide %K heavy episodic drinking %K emotion dysregulation %D 2017 %7 25.10.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: The need to develop effective and accessible interventions for suicidal individuals engaging in heavy episodic drinking (HED) cannot be understated. While the link between alcohol use and suicidality is a complex one that remains to be elucidated, emotion dysregulation may play a key role in alcohol-related suicide risk in these individuals. Objective: In the current study, an 8-week Internet-delivered dialectical behavior therapy (DBT) skills training intervention was developed and preliminarily evaluated for suicidal individuals who engage in HED to regulate emotions. The aim of the study is to evaluate the feasibility and effectiveness of the therapist-assisted and Internet-delivered intervention, and to inform the design of a subsequent full-scale study. Methods: The study was a pilot randomized controlled trial comparing participants receiving immediate-treatment (n=30) to waitlist controls (n=29) over a period of 16 weeks. Intervention effects will be assessed longitudinally using hierarchical linear modeling and generalized estimating equations, along with analyses of effect sizes and clinically significant change. The primary outcomes are suicidal ideation, alcohol problems, and emotion dysregulation. Secondary outcomes include alcohol-related consequences, reasons for living, skills use, and depression. Results: The trial is ongoing. A total of 60 individuals returned their informed consent and were randomized, of whom 59 individuals were intended to treat. A total of 50 participants in the study were retained through the 16-week enrollment. Conclusions: There is a dearth of evidence-based treatment for individuals presenting with high risk and complex behaviors. Furthermore, computerized interventions may provide a beneficial alternative to traditional therapies. The particular clinical features and treatment needs of suicidal individuals who also engage in HED constitute key domains for further investigation that are needed to consolidate the design of appropriate interventions for this high-risk population. Trial Registration: Clinicaltrials.gov NCT02932241; https://clinicaltrials.gov/ct2/show/NCT02932241 (Archived by WebCite at http://www.webcitation.org/6uJHdQsC2) %M 29070480 %R 10.2196/resprot.7767 %U http://www.researchprotocols.org/2017/10/e207/ %U https://doi.org/10.2196/resprot.7767 %U http://www.ncbi.nlm.nih.gov/pubmed/29070480 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 10 %P e202 %T A Telerehabilitation Approach to Enhance Quality of Life Through Exercise Among Adults With Paraplegia: Study Protocol %A Sweet,Shane Norman %A Rocchi,Meredith %A Arbour-Nicitopoulos,Kelly %A Kairy,Dahlia %A Fillion,Brigitte %+ Center for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), Department of Kinesiology and Physical Education, McGill University, Currie Gymnasium, 475 Pine Avenue West, Montreal, QC, H2W 1S4, Canada, 1 514 398 4184 ext 09903, shane.sweet@mcgill.ca %K telehealth %K spinal cord injuries %K exercise %K motivation %K telerehabilitation %D 2017 %7 19.10.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite compelling evidence linking physical activity and quality of life among adults with spinal cord injury (SCI), exercise participation rates are extremely low in this population. Unfortunately, a lack of behavioral exercise interventions, in particular theory-based randomized controlled trials (RCT), exists within the SCI literature. A pilot RCT is needed to first examine the feasibility to conduct such interventions and determine the appropriate effect size to inform future full-scale interventions. Objective: The overall goal of this pilot RCT is to test an 8-week innovative, video-based telerehabilitation intervention based on self-determination theory and aimed at enhancing the basic psychological needs, motivation, exercise participation, and quality of life‒related outcomes of adults with paraplegia. The objectives are to (1) determine if individuals in the intervention group have greater increases in their basic psychological needs and autonomous motivation and a decrease in controlled motivation compared to the control group, (2) determine whether the intervention group reports greater increases in exercise participation and quality of life‒related variables (eg, life satisfaction, participation in daily/social activities, depressive symptoms) compared to the control group, and (3) examine if adults with paraplegia who received the intervention report improved scores on psychosocial predictors of exercise (eg, action planning) and well-being (eg, positive affect) compared to the control group. We also aimed to examine the implementation characteristics of the intervention (eg, satisfaction with the technology, counselor’s ability to foster the psychological needs). Methods: Adults with paraplegia (N=24) living in the community will be recruited. All participants will be invited to complete assessments of their psychological needs, motivation, exercise, and quality of life‒related variables at three time points (baseline, 6, and 10 weeks). Following the baseline assessment, participants will be randomly assigned to the intervention or control group. Participants in the intervention group will participate in 8 weekly, 1-hour video-based telerehabilitation sessions with a trained physical activity counselor, while participants in the control group will be asked to continue with their regular routine. Results: We expect higher ratings of the basic psychological needs and autonomous motivation and lower scores for controlled motivation for the intervention group compared to the control group (Objective 1). We also expect that our video-based intervention will have moderate effects on exercise participation, as well as small-to-moderate positive effects on the quality of life‒related variables (Objective 2). Finally, we expect the intervention to have a small positive effect on psychosocial predictors of physical activity and well-being (Objective 3). Conclusions: We anticipate that the results will show that the intervention is appropriate for adults with paraplegia and feasible to test in a full-scale RCT. Trial Registration: ClinicalTrials.gov NCT02833935; https://clinicaltrials.gov/ct2/show/NCT02833935 (Archived by WebCite at http://www.webcitation.org/6u8U9x2yt) %M 29051134 %R 10.2196/resprot.8047 %U http://www.researchprotocols.org/2017/10/e202/ %U https://doi.org/10.2196/resprot.8047 %U http://www.ncbi.nlm.nih.gov/pubmed/29051134 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 10 %P e190 %T Efficacy of Seren@ctif, a Computer-Based Stress Management Program for Patients With Adjustment Disorder With Anxiety: Protocol for a Controlled Trial %A Servant,Dominique %A Leterme,Anne-Claire %A Barasino,Olivia %A Rougegrez,Laure %A Duhamel,Alain %A Vaiva,Guillaume %+ Stress and Anxiety Unit, Department of Psychiatry, University Hospital, Hopital Fontan, rue André Verhaeghe, Lille,, France, 33 320444460, dominique.servant@chru-lille.fr %K computer-assisted therapy %K eHealth %K cognitive therapy %K behavior therapy %K psychological stress %K adjustment disorders %K randomized controlled trial %D 2017 %7 02.10.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adjustment disorder with anxiety (ADA) is the most frequent and best characterized stress-related psychiatric disorder. The rationale for prescription of benzodiazepine monotherapy is a public health issue. Cognitive behavioral stress management programs have been studied in many countries. Several reports have shown beyond reasonable doubt their efficiency at reducing perceived stress and anxiety symptoms and improving patient quality of life. Considering the number of people who could benefit from such programs but are unable to access them, self-help programs have been offered. First presented as books, these programs became enriched with computer-based and digital supports. Regrettably, programs for stress management based on cognitive behavioral therapy (CBT), both face-to-face and digital support, have been only minimally evaluated in France. To our knowledge, the Seren@ctif program is the first French language self-help program for stress management using digital supports. Objective: The aim of this study is to assess the effectiveness of a 5-week standardized stress management program for reducing anxiety conducted via eLearning (iCBT) or through face-to-face interviews (CBT) with patients suffering from ADA compared with a wait list control group (WLC). These patients seek treatment in a psychiatric unit for anxiety disorders at a university hospital. The primary outcome is change in the State Trait Anxiety Inventory scale trait subscale (STAI-T) between baseline and 2-month visit. Methods: This is a multicenter, prospective, open label, randomized controlled study in 3 parallel groups with balanced randomization (1:1:1): computer-based stress management with minimal contact (not fully automated) (group 1), stress management with face-to-face interviews (group 2), and a WLC group that receives usual health care from a general practitioner (group 3). Programs are based on standard CBT principles and include 5 modules in 5 weekly sessions that include the following topics: stress and stress reaction and assessment; deep respiration and relaxation techniques; cognitive restructuring, mindfulness, and acceptance; behavioral skills as problem solving; and time management, healthy behaviors, and emotion regulation. In the Internet-based group, patients have minimal contact with a medical professional before and after every session. In the first session, a flash memory drive is supplied containing videos, audio files, a self-help book portfolio in the form of an eGuide, and log books providing the exercises to be completed between 2 sessions. The patient is encouraged to practice a 20-minute daily exercise 5 or 6 times per week. In the face-to-face group, patients receive the same program from a therapist with 5 weekly sessions without digital support. Interviews and self-assessments were collected face-to-face with the investigator. Results: The feasibility of this program is being tested, and results show good accessibility in terms of acceptance, understanding, and treatment credibility. Results are expected in 2018. Conclusions: To our knowledge, this is the first French study to examine the effectiveness of a computer-based stress management program for patients with ADA. The Seren@ctif program may be useful within the framework of a psychoeducative approach. It could also be advised for people suffering from other diseases related to stress and for people with a clinical level of perceived stress. Trial Registration: Clinicaltrials.gov NCT02621775; https://clinicaltrials.gov/ct2/show/NCT02621775 (Archived by WebCite at http://www.webcitation.org/6tQrkPs1u) %M 28970192 %R 10.2196/resprot.7976 %U https://www.researchprotocols.org/2017/10/e190/ %U https://doi.org/10.2196/resprot.7976 %U http://www.ncbi.nlm.nih.gov/pubmed/28970192 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 9 %P e171 %T Protocol for Co-Design, Development, and Open Trial of a Prototype Game-Based eHealth Intervention to Treat Anxiety in Young People With Long-Term Physical Conditions %A Thabrew,Hiran %A Stasiak,Karolina %A Merry,Sally %+ University of Auckland, Department of Psychological Medicine, Level 12 Support Block, Auckland Hospital, Park Road, Grafton, Auckland, 1149, New Zealand, 64 21402055, h.thabrew@auckland.ac.nz %K long-term physical conditions %K chronic illness %K anxiety %K eHealth %K gaming %K young people %K treatment %K cognitive behavior therapy %K biofeedback %D 2017 %7 22.09.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Approximately 10% to 12% of New Zealand young people (and 21% of Maori young people) have long-term physical conditions and are more likely to develop psychological problems, particularly anxiety and depression. Delayed treatment leads to worse management of physical conditions, school absence, and poorer long-term outcomes. Recently, electronic health (eHealth) interventions have been shown to be as good as face-to-face therapy and biofeedback techniques have been shown to enhance relaxation during the treatment of anxiety. In addition, young people with long-term physical conditions have expressed a preference for more technologically based support, including game-based interventions, to deal with psychological issues, particularly anxiety. Objective: The aim of this study is to develop a prototype game-based eHealth intervention to address anxiety in young people with long-term physical conditions. The game will be based on the principles of cognitive behavior therapy (CBT) and will integrate a module of biofeedback-based relaxation. Methods: During the first phase of the study, up to 48 young people with long-term physical conditions aged 13 to 18 years, attending a tertiary pediatric hospital will be invited to participate in a 3-stage series of co-design workshops. Following the design, development, and refinement of a working prototype, during the second phase of the study, a further 20 young people with long-term physical conditions and anxiety will be recruited from the same location to participate in an open pilot trial to evaluate its acceptability, usability, and preliminary efficacy. Results: Changes in anxiety will be measured using the Generalized Anxiety Disorder 7-item scale (GAD-7) and the Spence Child Anxiety Scales (SCAS) at the end of every module (recommended to be completed weekly), post intervention, and 3 months later. Usability of the intervention will be measured using the System Usability Scale (SUS) and by measuring frequency and quantity of use of the intervention. Acceptability of the intervention will be assessed using brief, open-ended questionnaires and semi-structured interviews, the data from which will be analyzed using a general inductive approach. Recruitment to the study commenced in January 2017 and data collection will be completed by the end of December 2017. Conclusions: If acceptable and useful, this game-based eHealth intervention may offer a cost-effective and clinically useful intervention for addressing the psychological needs of over 16,000 young people with long term health conditions in New Zealand. Trial Registration: Australian New Zealand Clinical Trials Network Registry (ANZCTR): ACTRN12616001253493p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371443 (Archived by WebCite at http://www.webcitation.org/6sYB716lf) %M 28939545 %R 10.2196/resprot.7250 %U http://www.researchprotocols.org/2017/9/e171/ %U https://doi.org/10.2196/resprot.7250 %U http://www.ncbi.nlm.nih.gov/pubmed/28939545 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 9 %P e181 %T Assessing the Efficacy and Safety of an 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) in the Idiopathic Intracranial Hypertension Drug Trial, IIH:DT: Clinical Methods and Design for a Phase II Randomized Controlled Trial %A Markey,Keira Annie %A Ottridge,Ryan %A Mitchell,James L %A Rick,Caroline %A Woolley,Rebecca %A Ives,Natalie %A Nightingale,Peter %A Sinclair,Alexandra J %+ Neurometabolism, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, The Medical School, Edgbaston, Birmingham, B15 2TT, United Kingdom, 44 1214158708, a.b.sinclair@bham.ac.uk %K 11beta-HSD1 %K randomised controlled trial %K clinical protocol %K idiopathic intracranial hypertension %K clinical trials, Phase II %D 2017 %7 18.09.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Idiopathic intracranial hypertension (IIH) is a condition with few effective management options. So far, there have been no randomized controlled trials evaluating new treatments in IIH. Objectives: The purpose of this paper is to outline the trial design for the Idiopathic Intracranial Hypertension Drug Trial (IIH:DT), assessing an innovative medical treatment in IIH and the rationale for the chosen trial methodology. Methods: IIH:DT is a phase II double-blind randomized placebo-controlled trial recruiting 30 female participants with active IIH (intracranial pressure >25cm H2 O and papilledema). Participants are randomized in a 1:1 ratio to 12 weeks of either AZD4017, an 11β-hydroxysteroid dehydrogenase type 1 inhibitor, or a matching placebo. They receive either 400 mg of AZD4017 or placebo twice daily. Participants are followed up at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16 postrandomization. The primary outcome is to examine the effect of AZD4017 on intracranial pressure, measured by lumbar puncture, over 12 weeks. Secondary outcome measures include IIH symptoms, visual function, papilledema, headache measures, safety, and tolerability. Cerebrospinal fluid, serum, plasma, urine, and adipose tissue are also taken for exploratory outcomes. Results: All participants were recruited between April 2014 and August 2016. Conclusions: IIH:DT is the first phase II double-blind randomized placebo-controlled trial assessing the efficacy and safety of the novel pharmacological intervention, AZD4017, for the treatment of IIH. Trial Registration: Clinicaltrials.gov NCT02017444; https://clinicaltrials.gov/ct2/show/NCT02017444 (Archived by WebCite at http://www.webcitation.org/6tVHesN6s) %M 28923789 %R 10.2196/resprot.7806 %U http://www.researchprotocols.org/2017/9/e181/ %U https://doi.org/10.2196/resprot.7806 %U http://www.ncbi.nlm.nih.gov/pubmed/28923789 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 8 %P e167 %T A Mobile Device App to Reduce Medication Errors and Time to Drug Delivery During Pediatric Cardiopulmonary Resuscitation: Study Protocol of a Multicenter Randomized Controlled Crossover Trial %A Siebert,Johan N %A Ehrler,Frederic %A Lovis,Christian %A Combescure,Christophe %A Haddad,Kevin %A Gervaix,Alain %A Manzano,Sergio %+ Department of Pediatric Emergency Medicine, Geneva Children’s Hospital, University Hospitals of Geneva, Avenue de la Roseraie 47, Geneva,, Switzerland, 41 22 372 45 55, Johan.Siebert@hcuge.ch %K resuscitation %K medication errors %K pharmaceutical preparations %K pediatrics %K biomedical technology %K children %K emergency %K simulation %D 2017 %7 22.08.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusions is complex and time-consuming. The need for individual specific weight-based drug dose calculation and preparation places children at higher risk than adults for medication errors. Following an evidence-based and ergonomic driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. In a prior single center randomized controlled trial, medication errors were reduced from 70% to 0% by using PedAMINES when compared with conventional preparation methods. Objective: The purpose of this study is to determine whether the use of PedAMINES in both university and smaller hospitals reduces medication dosage errors (primary outcome), time to drug preparation (TDP), and time to drug delivery (TDD) (secondary outcomes) during pediatric CPR when compared with conventional preparation methods. Methods: This is a multicenter, prospective, randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drug infusion rate table in the preparation of continuous drug infusion. The evaluation setting uses a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin. The study involving 120 certified nurses (sample size) will take place in the resuscitation rooms of 3 tertiary pediatric emergency departments and 3 smaller hospitals. After epinephrine-induced return of spontaneous circulation, nurses will be asked to prepare a continuous infusion of dopamine using either PedAMINES (intervention group) or the infusion table (control group) and then prepare a continuous infusion of norepinephrine by crossing the procedure. The primary outcome is the medication dosage error rate. The secondary outcome is the time in seconds elapsed since the oral prescription by the physician to drug delivery by the nurse in each allocation group. TDD includes TDP. Stress level during the resuscitation scenario will be assessed for each participant by questionnaire and recorded by the heart rate monitor of a fitness watch. The study is formatted according to the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH) and the Reporting Guidelines for Health Care Simulation Research. Results: Enrollment and data analysis started in March 2017. We anticipate the intervention will be completed in late 2017, and study results will be submitted in early 2018 for publication expected in mid-2018. Results will be reported in line with recommendations from CONSORT-EHEALTH and the Reporting Guidelines for Health Care Simulation Research . Conclusions: This paper describes the protocol used for a clinical trial assessing the impact of a mobile device app to reduce the rate of medication errors, time to drug preparation, and time to drug delivery during pediatric resuscitation. As research in this area is scarce, results generated from this study will be of great importance and might be sufficient to change and improve the pediatric emergency care practice. Trial Registration: ClinicalTrials.gov NCT03021122; https://clinicaltrials.gov/ct2/show/NCT03021122 (Archived by WebCite at http://www.webcitation.org/6nfVJ5b4R) %M 28830854 %R 10.2196/resprot.7901 %U http://www.researchprotocols.org/2017/8/e167/ %U https://doi.org/10.2196/resprot.7901 %U http://www.ncbi.nlm.nih.gov/pubmed/28830854 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 7 %P e135 %T Randomized Trial Comparing the Electronic Composite Psychosocial Screener YouthCHAT With a Clinician-Interview Assessment for Young People: A Study Protocol %A Thabrew,Hiran %A Corter,Arden %A Goodyear-Smith,Felicity %A Goldfinch,Mary %+ University of Auckland, Department of Psychological Medicine, University of Auckland, Level 12, Support Block, Auckland Hospital, Park Road, Grafton, Auckland, 1142, New Zealand, 64 21402055, h.thabrew@auckland.ac.nz %K mass screening %K adolescents %K substance-related disorders %K depression %K anxiety %K primary health care %K school health %K services %K chronic disease %D 2017 %7 31.07.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Psychosocial problems such as depression, anxiety, and substance abuse are common and burdensome in young people, particularly those with long-term physical conditions such as asthma and diabetes. In New Zealand, “screening” for such problems is undertaken routinely only with Year 9 students in low-decile schools and opportunistically in pediatric settings using a nonvalidated and time-consuming clinician-administered Home, Education/employment, Eating, Activity, Drugs, Sexuality, Suicide/depression, Safety (HEEADSSS) interview. The Youth version, Case-finding and Help Assessment Tool (YouthCHAT) is a relatively new, locally developed, eTablet-based composite screener for identifying similar psychosocial issues to HEEADSSS. Based on individually validated screening instruments, it is self-administered within minutes. Preliminary testing has revealed its acceptability to young people, but further research is required to expand its modules to cover all HEEADSSS domains, to evaluate its acceptability for young people with and without long-term physical conditions, and to compare its effectiveness against HEEADSSS. Objective: Our aim is to (1) ascertain acceptability and utility of YouthCHAT for children with long-term physical illness and high school students, (2) validate three additional YouthCHAT domains against comparable HEEADSSS domains, and (3) compare the performance of YouthCHAT and HEEADSSS in the high school setting. Methods: During the first phase of the study, three additional YouthCHAT domains were codesigned with high school students. During the second phase of the study, the updated version of YouthCHAT will be administered to 30 young people with long-term physical conditions, and to 150 high school students either before or after HEEADSSS in the form of a randomized trial with counter-balanced design. Primary outcomes include comparability between HEEADSSS and YouthCHAT in detecting psychosocial issues, and time to administer; acceptability of YouthCHAT as an acceptable alternative or companion to HEEADSSS assessment; and the utility of YouthCHAT in helping streamline assessment processes. Results: Recruitment for the first phase of this project commenced in November 2016, and the phase will run from February to November 2017. Conclusions: If YouthCHAT is found to be acceptable to study participants and as effective as a HEEADSSS assessment, it could be an innovative and more efficient means of routine screening for common psychosocial health issues in young people with and without long-term physical conditions. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12616001243404p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371422 (Archived by WebCite at http://www.webcitation.org/ 6rmlEiM1L) %M 28760727 %R 10.2196/resprot.7995 %U http://www.researchprotocols.org/2017/7/e135/ %U https://doi.org/10.2196/resprot.7995 %U http://www.ncbi.nlm.nih.gov/pubmed/28760727 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 7 %P e134 %T Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study %A Park,Linda G %A Collins,Eileen G %A Shim,Janet K %A Whooley,Mary A %+ Department of Veterans Affairs, Community Health Systems, University of California, San Francisco, 2 Koret Way, Box 0608, Room 531A, San Francisco, CA, 94143, United States, 1 415 502 6616, linda.park@ucsf.edu %K text messaging %K mobile application %K mobile health %K cardiovascular disease %K medication %K adherence %D 2017 %7 18.07.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. Objective: The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT). Methods: We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports. Results: Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. Conclusions: Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence. Trial Registration: ClinicalTrials.gov NCT03022669 %M 28720557 %R 10.2196/resprot.7327 %U http://www.researchprotocols.org/2017/7/e134/ %U https://doi.org/10.2196/resprot.7327 %U http://www.ncbi.nlm.nih.gov/pubmed/28720557 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e105 %T PREventive Care Infrastructure based On Ubiquitous Sensing (PRECIOUS): A Study Protocol %A Castellano-Tejedor,Carmina %A Moreno,Jordi %A Ciudin,Andrea %A Parramón,Gemma %A Lusilla-Palacios,Pilar %+ University Hospital Vall d’Hebron - Vall d'Hebron Research Institute, Department of Psychiatry, CIBERSAM, Autonomous University of Barcelona, Passeig Vall d'Hebron 119-129, Barcelona, 08035, Spain, 34 934893649 ext 3649, ninacastej@yahoo.es %K mHealth %K motivational interviewing %K physical activity %K diet %K sustained motivation %K adherence %D 2017 %7 31.05.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: mHealth has experienced a huge growth during the last decade. It has been presented as a new and promising pathway to increase self-management of health and chronic conditions in several populations. One of the most prolific areas of mHealth has been healthy lifestyles promotion. However, few mobile apps have succeeded in engaging people and ensuring sustained use. Objective: This paper describes the pilot test protocol of the PReventive Care Infrastructure based on Ubiquitous Sensing (PRECIOUS) project, aimed at validating the PRECIOUS system with end users. This system includes, within a motivational framework, the Bodyguard2 sensor (accelerometer with heart rate monitoring) and the PRECIOUS app. Methods: This is a pilot experimental study targeting morbidly obese prediabetic patients who will be randomized to three conditions: (1) Group 1 - Control group (Treatment as usual with the endocrinologist and the nurse + Bodyguard2), (2) Group 2 - PRECIOUS system (Bodyguard2 + PRECIOUS app), and (3) Group 3 - PRECIOUS system (Bodyguard2 + PRECIOUS app + Motivational Interviewing). The duration of the study will be 3 months with scheduled follow-up appointments within the scope of the project at Weeks 3, 5, 8, and 12. During the study, several measures related to healthy lifestyles, weight management, and health-related quality of life will be collected to explore the effectiveness of PRECIOUS to foster behavior change, as well as user acceptance, usability, and satisfaction with the solution. Results: Because of the encouraging results shown in similar scientific work analyzing health apps acceptance in clinical settings, we expect patients to widely accept and express satisfaction with PRECIOUS. We also expect to find acceptable usability of the preventive health solution. The recruitment of the pilot study has concluded with the inclusion of 31 morbidly obese prediabetic patients. Results are expected to be available in mid-2017. Conclusions: Adopting and maintaining healthy habits may be challenging in people with chronic conditions who usually need regular support to ensure mid/long-term adherence to recommendations and behavior change. Thus, mHealth could become a powerful and efficient tool since it allows continuous communication with users and immediate feedback. The PRECIOUS system is an innovative preventive health care solution aimed at enhancing inner motivation from users to change their lifestyles and adopt healthier habits. PRECIOUS includes ubiquitous sensors and a scientifically grounded app to address three main components of health: physical activity, diet, and stress levels. Trial Registration: Clinicaltrials.gov NCT02818790; https://clinicaltrials.gov/ct2/show/NCT02818790 (Archived by WebCite at http://www.webcitation.org/6qfzdfMoU) %M 28566263 %R 10.2196/resprot.6973 %U http://www.researchprotocols.org/2017/5/e105/ %U https://doi.org/10.2196/resprot.6973 %U http://www.ncbi.nlm.nih.gov/pubmed/28566263 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e91 %T The Use of Text Messaging to Improve the Hospital-to-Community Transition in Acute Coronary Syndrome Patients (Txt2Prevent): Intervention Development and Pilot Randomized Controlled Trial Protocol %A Ross,Emily S %A Sakakibara,Brodie M %A Mackay,Martha H %A Whitehurst,David GT %A Singer,Joel %A Toma,Mustafa %A Corbett,Kitty K %A Van Spall,Harriette GC %A Rutherford,Kimberly %A Gheorghiu,Bobby %A Code,Jillianne %A Lear,Scott A %+ Division of Cardiology, Providence Health Care, Healthy Heart Program St. Paul's Hospital, B180-1081 Burrard Street, Vancouver, BC,, Canada, 1 604 682 2344 ext 62778, slear@providencehealth.bc.ca %K acute coronary syndrome %K cardiovascular diseases %K heart diseases %K mobile health %K text messaging %K mobile phone %K SMS %D 2017 %7 23.05.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Acute coronary syndrome, including acute myocardial infarction (AMI), is one of the leading causes for hospitalization, with AMI 30-day readmission rates around 20%. Supporting patient information needs and increasing adherence to recommended self-management behaviors during transition from hospital to home has the potential to improve patient outcomes. Text messages have been effective in other interventions and may be suitable to provide support to patients during this transition period. Objective: The goal of this study is to pilot test a text messaging intervention program (Txt2Prevent) that supports acute coronary syndrome patients for 60 days postdischarge. The primary objective is to compare self-management, as measured by the Health Education Impact Questionnaire, between patients receiving only usual care versus those who receive usual care plus the Txt2Prevent intervention. The secondary objectives are to compare medication adherence, health-related quality of life, self-efficacy, health care resource use (and associated costs), all-cause and cardiovascular disease (CVD) readmission, and all-cause and CVD mortality rates between the 2 groups. The third objective is to assess acceptability of the text messaging intervention and feasibility of the study protocol. Methods: This is a randomized controlled trial with blinding of outcome assessors. The Txt2Prevent program includes automated text messages to patients about standard follow-up care, general self-management, and healthy living. The content of the text messages was informed by and developed based on interviews with patients, discharge materials, theoretical domains of behavior, and a clinical advisory group composed of patients, clinicians, and researchers. We will recruit 76 consecutive cardiac in-patients with acute coronary syndrome who are treated with either medical management or percutaneous coronary intervention from a hospital in Vancouver, Canada. Results: Assessments at baseline will include measures for demographic information, self-management, health-related quality of life, and self-efficacy. Assessments at follow-up will include medication adherence, readmissions, health care resource use, and mortality in addition to the reassessment of baseline measures. Baseline assessments are done in-person while follow-up assessments are completed through a combination of mailed packages and phone calls. Semistructured interviews with participants will also be performed to better understand participant experiences managing their condition and with the text messages. Conclusions: This study will determine preliminary efficacy, feasibility, and acceptability of the Txt2Prevent program to support acute coronary syndrome patients in the transition to home following hospital discharge. The results of this study will be used to inform a larger trial. Trial Registration: ClinicalTrials.gov NCT02336919; https://clinicaltrials.gov/ct2/show/NCT02336919 (Archived by WebCite at http://www.webcitation.org/6qMjEqo6O) %M 28536088 %R 10.2196/resprot.6968 %U http://www.researchprotocols.org/2017/5/e91/ %U https://doi.org/10.2196/resprot.6968 %U http://www.ncbi.nlm.nih.gov/pubmed/28536088 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 4 %P e64 %T Evaluation of a Web-Based Tailored Nursing Intervention (TAVIE en m@rche) Aimed at Increasing Walking After an Acute Coronary Syndrome: A Multicenter Randomized Controlled Trial Protocol %A Kayser,John William %A Cossette,Sylvie %A Côté,José %A Bourbonnais,Anne %A Purden,Margaret %A Juneau,Martin %A Tanguay,Jean-Francois %A Simard,Marie-Josée %A Dupuis,Jocelyn %A Diodati,Jean G %A Tremblay,Jean-Francois %A Maheu-Cadotte,Marc-André %A Cournoyer,Daniel %+ Montreal Heart Institute Research Center and Université de Montréal, 5000, rue Bélanger, Room S-2490, Montréal, QC, H1T 1C8, Canada, 1 514 376 3330 ext 4026, john.kayser@umontreal.ca %K acute coronary syndrome %K secondary prevention %K physical activity %K walking %K Internet %K computer-tailored %K eHealth %K Strengths-Based Nursing Care %K Self-Determination Theory %K nursing intervention %D 2017 %7 27.04.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite the health benefits of increasing physical activity in the secondary prevention of acute coronary syndrome (ACS), up to 60% of ACS patients are insufficiently active. Evidence supporting the effect of Web-based interventions on increasing physical activity outcomes in ACS patients is growing. However, randomized controlled trials (RCTs) using Web-based technologies that measured objective physical activity outcomes are sparse. Objective: Our aim is to evaluate in insufficiently active ACS patients, the effect of a fully automated, Web-based tailored nursing intervention (TAVIE en m@rche) on increasing steps per day. Methods: A parallel two-group multicenter RCT (target N=148) is being conducted in four major teaching hospitals in Montréal, Canada. An experimental group receiving the 4-week TAVIE en m@rche intervention plus a brief “booster” at 8 weeks, is compared with the control group receiving hyperlinks to publicly available websites. TAVIE en m@rche is based on the Strengths-Based Nursing Care orientation to nursing practice and the Self-Determination Theory of human motivation. The intervention is centered on videos of a nurse who delivers the content tailored to baseline levels of self-reported autonomous motivation, perceived competence, and walking behavior. Participants are recruited in hospital and are eligible if they report access to a computer and report less than recommended physical activity levels 6 months before hospitalization. Most outcome data are collected online at baseline, and 5 and 12 weeks postrandomization. The primary outcome is change in accelerometer-measured steps per day between randomization and 12 weeks. The secondary outcomes include change in steps per day between randomization and 5 weeks, and change in self-reported energy expenditure for walking and moderate to vigorous physical activity between randomization, and 5 and 12 weeks. Theoretical outcomes are the mediating role of self-reported perceived autonomy support, autonomous and controlled motivations, perceived competence, and barrier self-efficacy on steps per day. Clinical outcomes are quality of life, smoking, medication adherence, secondary prevention program attendance, health care utilization, and angina frequency. The potential moderating role of sex will also be explored. Analysis of covariance models will be used with covariates such as sex, age, fatigue, and depression symptoms. Allocation sequence is concealed, and blinding will be implemented during data analysis. Results: Recruitment started March 30, 2016. Data analysis is planned for November 2017. Conclusions: Finding alternative interventions aimed at increasing the adoption of health behavior changes such as physical activity in the secondary prevention of ACS is clearly needed. Our RCT is expected to help support the potential efficacy of a fully automated, Web-based tailored nursing intervention on the objective outcome of steps per day in an ACS population. If this RCT is successful, and after its implementation as part of usual care, TAVIE en m@rche could help improve the health of ACS patients at large. Trial Registration: ClinicalTrials.gov NCT02617641; https://clinicaltrials.gov/ct2/show/NCT02617641 (Archived by WebCite at http://www.webcitation.org/6pNNGndRa) %M 28450272 %R 10.2196/resprot.6430 %U http://www.researchprotocols.org/2017/4/e64/ %U https://doi.org/10.2196/resprot.6430 %U http://www.ncbi.nlm.nih.gov/pubmed/28450272 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 4 %P e68 %T Testing a Computerized Cognitive Training Protocol in Adults Aging With HIV-Associated Neurocognitive Disorders: Randomized Controlled Trial Rationale and Protocol %A Vance,David %A Fazeli,Pariya %A Shacka,John %A Nicholson,William %A McKie,Peggy %A Raper,James %A Azuero,Andres %A Wadley,Virginia %A Ball,Karlene %+ School of Nursing, University of Alabama at Birmingham, 1701 University Boulevard, Birmingham, AL, 35294, United States, 1 2059347589, devance@uab.edu %K cognitive aging %K cognitive remediation therapy %K cognition therapy %K HIV associated cognitive motor complex %D 2017 %7 26.04.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: HIV-associated neurocognitive disorders occur in nearly 50% of adults with HIV. Such disorders can interfere with everyday functioning such as driving and medication adherence. Therefore, cognitive interventions are needed to address such neurocognitive disorders as well as improve everyday functioning, especially as people age with HIV. Objective: This article reports and discusses the overall rationale and development of speed of processing training, a computerized Internet cognitive training program, to improve this specific neurocognitive ability as well as everyday functioning and quality of life in adults aging with HIV. Although this protocol has been shown to improve speed of processing, everyday functioning, and quality of life in healthy, community-dwelling older adults in the advanced cognitive training in vital elderly (ACTIVE) study, its efficacy in adults aging with HIV has not been established. Nevertheless, such a cognitive intervention is particularly germane as 52%-59% of adults with HIV experience HIV-associated neurocognitive disorders (HAND), and both the frequency and severity of such disorders may increase with advancing age. Methods: The description of this longitudinal randomized controlled trial covers the following: (1) rationale for speed of processing training in this clinical population, (2) overview of overall study design, (3) eligibility criteria and HAND, (4) intervention dosage, (5) assessment battery, and (6) examination of biomarkers. Results: The project was funded in April 2016 and enrolment is on-going. The first results are expected to be submitted for publication in 2020. Conclusions: Similar novel cognitive intervention approaches are suggested as they may be of value to those with HAND and may utilize similar features of this current randomized controlled trial (RCT) protocol to examine their therapeutic efficacy. Trial Registration: ClinicalTrials.gov NCT02758093; https://clinicaltrials.gov/ct2/show/NCT02758093 (Archived by Webcite at http://www.webcitation.org/6p8C5fBCX) %M 28446421 %R 10.2196/resprot.6625 %U http://www.researchprotocols.org/2017/4/e68/ %U https://doi.org/10.2196/resprot.6625 %U http://www.ncbi.nlm.nih.gov/pubmed/28446421 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 4 %P e73 %T HomeStyles, A Web-Based Childhood Obesity Prevention Program for Families With Preschool Children: Protocol for a Randomized Controlled Trial %A Byrd-Bredbenner,Carol %A Martin-Biggers,Jennifer %A Koenings,Mallory %A Quick,Virginia %A Hongu,Nobuko %A Worobey,John %+ Rutgers University, Department of Nutritional Sciences, 26 Nichol Avenue, New Brunswick, NJ, 08901, United States, 1 848 932 0965, gingermquick@gmail.com %K childhood obesity %K nutrition %K physical activity %K sleep %K prevention %K parents %K children %D 2017 %7 25.04.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: The home environment is where young children spend most of their time, and is critically important to supporting behaviors that promote health and prevent obesity. However, the home environment and lifestyle patterns remain understudied, and few interventions have investigated parent-led makeovers designed to create home environments that are supportive of optimal child health and healthy child weights. Objective: The aim of the HomeStyles randomized controlled trial (RCT) is to determine whether the Web-based HomeStyles intervention enables and motivates parents to shape the weight-related aspects of their home environments and lifestyle behavioral practices (diet, exercise, and sleep) to be more supportive of their preschool children’s optimal health and weight. Methods: A rigorous RCT utilizing an experimental group and an attention control group, receiving a bona fide contemporaneous treatment equal in nonspecific treatment effects and differing only in subject matter content, will test the effect of HomeStyles on a diverse sample of families with preschool children. This intervention is based on social cognitive theory and uses a social ecological framework, and will assess: intrapersonal characteristics (dietary intake, physical activity level, and sleep) of parents and children; family interpersonal or social characteristics related to diet, physical activity, media use, and parental values and self-efficacy for obesity-preventive practices; and home environment food availability, physical activity space and supports in and near the home, and media availability and controls in the home. Results: Enrollment for this study has been completed and statistical data analyses are currently underway. Conclusions: This paper describes the HomeStyles intervention with regards to: rationale, the intervention’s logic model, sample eligibility criteria and recruitment, experimental group and attention control intervention content, study design, instruments, data management, and planned analyses. %M 28442452 %R 10.2196/resprot.7544 %U http://www.researchprotocols.org/2017/4/e73/ %U https://doi.org/10.2196/resprot.7544 %U http://www.ncbi.nlm.nih.gov/pubmed/28442452 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 4 %P e53 %T A Mobile App for Chronic Disease Self-Management: Protocol for a Randomized Controlled Trial %A Ownby,Raymond L %A Acevedo,Amarilis %A Waldrop-Valverde,Drenna %A Caballero,Joshua %A Simonson,Michael %A Davenport,Rosemary %A Kondwani,Kofi %A Jacobs,Robin J %+ Nova Southeastern University, Department of Psychiatry and Behavioral Medicine, Room 1477, 3200 South University Drive, Fort Lauderdale, FL, 33314, United States, 1 9542621481, ro71@nova.edu %K health literacy %K chronic disease self-management %K health disparities %K patient activation %K health related quality of life %K mobile health technology %D 2017 %7 05.04.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Health literacy is a critically important skill that helps people become active participants in their health care. Multiple studies in the United States and across the world have documented the association of health literacy with multiple health outcomes. In particular, the elderly and many members of minority groups have been shown to have low levels of health literacy; the same groups are disproportionately affected by chronic illnesses. These twin burdens affect the people most in need of the skills and knowledge required for coping with chronic illnesses. Chronic disease self-management (CDSM) is a logical target for a general health literacy intervention. In an approach that spans across specific diseases, CDSM targets problems and skills needed to cope with issues such as fatigue, pain, stress, depression, sleep disturbance, and treatment adherence. In a previous study, we showed that a computer-delivered tailored information intervention targeting health literacy could improve treatment and adherence and be cost effective, but it is not clear that this same strategy will be effective in persons with low health literacy and multiple chronic conditions. Objective: The purpose of this study is to develop a computer-delivered mobile intervention that will provide individuals with chronic conditions the necessary information to cope with their conditions. Methods: In this project, we will complete a qualitative study on the status and needs of individuals with more than one chronic condition. Results of this study will be used to develop a mobile tailored information app that will address self-management challenges in the areas of pain, sleep, fatigue, depression, anger, stress, memory problems, and treatment adherence. The impact of the intervention on patient quality of life, patient-provider relationships, health literacy, and patient activation will be assessed. We will also explore the extent to which health literacy mediates important outcomes, such as health-related quality of life and health service utilization. Results: We are currently completing the preliminary qualitative and usability studies that will inform the content and design of the intervention. We anticipate that the intervention will be complete in 2017, and the clinical trial of its efficacy will also commence in 2017. Conclusions: Results will provide evidence on the usefulness of a mobile tailored information app for improving health literacy, patient activation, health-related quality of life, and self-reported health in patients with multiple chronic conditions. Trial Registration: Clinicaltrials.gov NCT02922439; https://clinicaltrials.gov/ct2/show/NCT02922439 (Archived by WebCite at http://www.webcitation.org/6pTiqDAyN) %M 28381395 %R 10.2196/resprot.7272 %U http://www.researchprotocols.org/2017/4/e53/ %U https://doi.org/10.2196/resprot.7272 %U http://www.ncbi.nlm.nih.gov/pubmed/28381395 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 3 %P e32 %T Supporting the Delivery of Total Knee Replacements Care for Both Patients and Their Clinicians With a Mobile App and Web-Based Tool: Randomized Controlled Trial Protocol %A Hussain,M Sazzad %A Li,Jane %A Brindal,Emily %A van Kasteren,Yasmin %A Varnfield,Marlien %A Reeson,Andrew %A Berkovsky,Shlomo %A Freyne,Jill %+ Health and Biosecurity, Commonwealth Scientific and Industrial Research Organization, GPO Box 76, Epping, NSW, 1710, Australia, 61 2 9372 4177, sazzad.hussain@csiro.au %K orthopedic %K TKR %K rehabilitation %K physiotherapy %K mHealth %K eHealth %D 2017 %7 01.03.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Total knee replacement (TKR) surgeries have increased in recent years. Exercise programs and other interventions following surgery can facilitate the recovery process. With limited clinician contact time, patients with TKR have a substantial burden of self-management and limited communication with their care team, thus often fail to implement an effective rehabilitation plan. Objective: We have developed a digital orthopedic rehabilitation platform that comprises a mobile phone app, wearable activity tracker, and clinical Web portal in order to engage patients with self-management tasks for surgical preparation and recovery, thus addressing the challenges of adherence to and completion of TKR rehabilitation. The study will determine the efficacy of the TKR platform in delivering information and assistance to patients in their preparation and recovery from TKR surgery and a Web portal for clinician care teams (ie, surgeons and physiotherapists) to remotely support and monitor patient progress. Methods: The study will evaluate the TKR platform through a randomized controlled trial conducted at multiple sites (N=5) in a number of states in Australia with 320 patients undergoing TKR surgery; the trial will run for 13 months for each patient. Participants will be randomized to either a control group or an intervention group, both receiving usual care as provided by their hospital. The intervention group will receive the app and wearable activity tracker. Participants will be assessed at 4 different time points: 4 weeks before surgery, immediately before surgery, 12 weeks after surgery, and 52 weeks after surgery. The primary outcome measure is the Oxford Knee Score. Secondary outcome measures include quality of life (Short-Form Health Survey); depression, anxiety, and stress (Depression, Anxiety, and Stress Scales); self-motivation; self-determination; self-efficacy; and the level of satisfaction with the knee surgery and care delivery. The study will also collect quantitative usage data related to all components (app, activity tracker, and Web portal) of the TKR platform and qualitative data on the perceptions of the platform as a tool for patients, carers, and clinicians. Finally, an economic evaluation of the impact of the platform will be conducted. Results: Development of the TKR platform has been completed and deployed for trial. The research protocol is approved by 2 human research ethics committees in Australia. A total of 5 hospitals in Australia (2 in New South Wales, 2 in Queensland, and 1 in South Australia) are expected to participate in the trial. Conclusions: The TKR platform is designed to provide flexibility in care delivery and increased engagement with rehabilitation services. This trial will investigate the clinical and behavioral efficacy of the app and impact of the TKR platform in terms of service satisfaction, acceptance, and economic benefits of the provision of digital services. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12616000504415; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370536 (Archived by WebCite at http://www.webcitation.org/6oKES0Gp1) %M 28249832 %R 10.2196/resprot.6498 %U http://www.researchprotocols.org/2017/3/e32/ %U https://doi.org/10.2196/resprot.6498 %U http://www.ncbi.nlm.nih.gov/pubmed/28249832 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e245 %T Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial %A van der Meij,Eva %A Huirne,Judith AF %A Bouwsma,Esther VA %A van Dongen,Johanna M %A Terwee,Caroline B %A van de Ven,Peter M %A den Bakker,Chantal M %A van der Meij,Suzan %A van Baal,W Marchien %A Leclercq,Wouter KG %A Geomini,Peggy MAJ %A Consten,Esther CJ %A Schraffordt Koops,Steven E %A van Kesteren,Paul JM %A Stockmann,Hein BAC %A ten Cate,A Dorien %A Davids,Paul HP %A Scholten,Petrus C %A van den Heuvel,Baukje %A Schaafsma,Frederieke G %A Meijerink,Wilhelmus JHJ %A Bonjer,H Jaap %A Anema,Johannes R %+ EMGO+ Institute for Health and Care Research, Department of Public and Occupational Health, VU University Medical Center, Van der Boechorststraat 7, Room B-555, Amsterdam, Netherlands, 31 20444 57 03, ev.vandermeij@vumc.nl %K eHealth %K mHealth %K inguinal hernia surgery %K cholecystectomy %K adnexal surgery %K perioperative care %K convalescence %K return to normal activities %K cost-effectiveness %K economic evaluation %D 2016 %7 21.12.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. Objective: With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. Methods: This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle. Results: The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted. Conclusions: We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower. ClinicalTrial: Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy) %M 28003177 %R 10.2196/resprot.6580 %U http://www.researchprotocols.org/2016/4/e245/ %U https://doi.org/10.2196/resprot.6580 %U http://www.ncbi.nlm.nih.gov/pubmed/28003177 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e228 %T Engaging Moms on Teen Indoor Tanning Through Social Media: Protocol of a Randomized Controlled Trial %A Pagoto,Sherry L %A Baker,Katie %A Griffith,Julia %A Oleski,Jessica L %A Palumbo,Ashley %A Walkosz,Barbara J %A Hillhouse,Joel %A Henry,Kimberly L %A Buller,David B %+ Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA, 01655, United States, 1 508 856 2092, Sherry.Pagoto@umassmed.edu %K skin cancer %K indoor tanning %K melanoma %K Facebook %K social media %K health communication %D 2016 %7 29.11.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Indoor tanning elevates the risk for melanoma, which is now the most common cancer in US women aged 25-29. Public policies restricting access to indoor tanning by minors to reduce melanoma morbidity and mortality in teens are emerging. In the United States, the most common policy restricting indoor tanning in minors involves parents providing either written or in person consent for the minor to purchase a tanning visit. The effectiveness of this policy relies on parents being properly educated about the harms of indoor tanning to their children. Objective: This randomized controlled trial will test the efficacy of a Facebook-delivered health communication intervention targeting mothers of teenage girls. The intervention will use health communication and behavioral modification strategies to reduce mothers’ permissiveness regarding their teenage daughters’ use of indoor tanning relative to an attention-control condition with the ultimate goal of reducing indoor tanning in both daughters and mothers. Methods: The study is a 12-month randomized controlled trial comparing 2 conditions: an attention control Facebook private group where content will be relevant to teen health with 25% focused on prescription drug abuse, a topic unrelated to tanning; and the intervention condition will enter participants into a Facebook private group where 25% of the teen health content will be focused on indoor tanning. A cohort of 2000 mother-teen daughter dyads will be recruited to participate in this study. Only mothers will participate in the Facebook groups. Both mothers and daughters will complete measures at baseline, end of intervention (1-year) and 6 months post-intervention. Primary outcomes include mothers’ permissiveness regarding their teenage daughters’ use of indoor tanning, teenage daughters’ perception of their mothers’ permissiveness, and indoor tanning by both mothers and daughters. Results: The first dyad was enrolled on March 31, 2016, and we anticipate completing this study by October 2019. Conclusions: This trial will deliver social media content grounded in theory and will test it in a randomized design with state-of-the-art measures. This will contribute much needed insights on how to employ social media for health behavior change and disease prevention both for indoor tanning and other health risk behaviors and inform future social media efforts by public health and health care organizations. ClinicalTrial: Clinicaltrials.gov NCT02835807; https://clinicaltrials.gov/ct2/show/NCT02835807 (Archived by WebCite at http://www.webcitation.org/6mDMICcCE). %M 27899339 %R 10.2196/resprot.6624 %U http://www.researchprotocols.org/2016/4/e228/ %U https://doi.org/10.2196/resprot.6624 %U http://www.ncbi.nlm.nih.gov/pubmed/27899339 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e218 %T The Effects of an E-Mental Health Program and Job Coaching on the Risk of Major Depression and Productivity in Canadian Male Workers: Protocol for a Randomized Controlled Trial %A Wang,JianLi %A Patten,Scott B %A Lam,Raymond W %A Attridge,Mark %A Ho,Kendall %A Schmitz,Norbert %A Marchand,Alain %A Lashewicz,Bonnie M %+ Department of Psychiatry, University of Calgary, Room 4D69, TRW Building, 3280 Hospital Dr. NW, Calgary, AB, T2N 4Z6, Canada, 1 4032108653, jlwang@ucalgary.ca %K Internet %K RCT %K men %K workplace %K major depression %K prevention %D 2016 %7 15.11.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Major depression (MDE) is prevalent in men and affects men’s health and productivity. Because of the stigma against depression and social/gender norms, men are less likely to seek help for emotion and stress-related issues. Therefore, innovative solutions tailored for men are needed. With rapid development of the Internet and information technologies, one promising solution that has drawn considerable attentions is electronic mental (e-mental) health programs and services. Objective: The objective of our study is to evaluate the effectiveness of the e-mental health program BroHealth on reducing the risk of having MDE and improving productivity and return to investment. Methods: The target population is Canadian working men who are at high risk of having MDE (N=1200). Participants will be recruited using the method of random digit dialing across the country and workplace advertisement. Eligible participants will be randomly allocated into the following groups: (1) a control group, (2) a group receiving BroHealth only, and (3) a group receiving BroHealth and telephone-based job coaching service. The groups will be assessed at 6 and 12 months after randomization. The primary outcome is the risk proportion of MDE over 12 months, which will be assessed by the World Health Organization's (WHO’s) Composite International Diagnostic Interview-Short Form for Major Depression. Intention-to-treat principle will be used in the analysis. The 12-month proportions of MDE in the groups will be estimated and compared. Logistic regression modeling will be used to examine the effect of the intervention on the outcome, controlling for the effects of baseline confounders. Results: It is anticipated that the randomized controlled trial (RCT) will be completed by 2018. This study has been approved by the Conjoint Health Research Ethics Review Board of the University of Calgary. The trial is funded by a team grant from the Movember Foundation, a global charity for men’s health. BroHealth was developed at the Digital Emergency Medicine, University of British Columbia, and the usability testing has been completed. Conclusions: BroHealth was developed based on men’s needs. We hypothesized that BroHealth will be an effective, acceptable, and sustainable product for early prevention of MDE in workplaces. ClinicalTrial: Clinicaltrials.gov NCT02777112; https://clinicaltrials.gov/ct2/show/NCT02777112 (Archived by WebCite at http://www.webcitation.org/6lbOQpiCG) %M 27847352 %R 10.2196/resprot.6350 %U http://www.researchprotocols.org/2016/4/e218/ %U https://doi.org/10.2196/resprot.6350 %U http://www.ncbi.nlm.nih.gov/pubmed/27847352 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e205 %T Effectiveness of a Technology-Based Injury Prevention Program for Enhancing Mothers’ Knowledge of Child Safety: Protocol for a Randomized Controlled Trial %A Chow,Chun Bong %A Wong,Wilfred Hing-Sang %A Leung,Wing Cheong %A Tang,Mary Hoi-Yin %A Chan,Ko Ling %A Or,Calvin KL %A Li,Tim MH %A Ho,Frederick Ka Wing %A Lo,Daniel %A Ip,Patrick %+ Department of Paediatrics and Adolescent Medicine, The University of Hong Kong, 1/F, New Clinical Building, Queen Mary Hospital, Pokfulam, Hong Kong,, China, 852 28198501, patricip@hku.hk %K child safety %K injury prevention %K technology-based intervention %K anticipatory guidance %K randomized controlled trial %D 2016 %7 31.10.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Provision of anticipatory guidance for parents is recommended as an effective strategy to prevent injuries among young children. Technology-based anticipatory guidance has been suggested to reinforce the effectiveness of injury prevention and improve parents’ knowledge of child safety. Objective: This study aims to examine the effectiveness of a technology-based injury prevention program with parental anticipatory guidance for enhancing mothers’ knowledge of child safety. Methods: In this randomized controlled trial, 308 mothers will be recruited from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong. Participating mothers will be randomly assigned into intervention and control groups. Mothers in the intervention group will be given free access to a technology-based injury prevention program with anticipatory guidance, whereas mothers in the control group will be given a relevant booklet on parenting. The injury prevention program, available as a website or on a mobile app, includes behavioral components based on the Theory of Planned Behavior. The primary outcome measure will be the change in the mother’s knowledge of child safety. The secondary outcome measures will be age-appropriate domestic safety knowledge, attitudes, intentions, perceived behavioral control, and self-reported behavior related to home safety practice. We will also determine dose-response relationships between the outcome measures and the website and mobile app usage. Results: Enrolment of participants will begin in October 2016. Results are expected by June 2018. Conclusions: Parents will be able to easily access the domestic injury prevention website to find information regarding child injury prevention. It is anticipated that the technology-based intervention will help parents improve their knowledge of child safety and raise their awareness about the consequences of domestic injuries and the importance of prevention. Trial Registration: Clinicaltrials.gov Clinicaltrials.gov NCT02835768; http://clinicaltrials.gov/ct2/show/NCT02835768 (Archived by WebCite at http://www.webcitation/6lbXYM6b9) %M 27799138 %R 10.2196/resprot.6216 %U http://www.researchprotocols.org/2016/4/e205/ %U https://doi.org/10.2196/resprot.6216 %U http://www.ncbi.nlm.nih.gov/pubmed/27799138 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e202 %T Protocol for a Randomized Controlled Trial of Proactive Web-Based Versus Telephone-Based Information and Support: Can Electronic Platforms Deliver Effective Care for Lung Cancer Patients? %A Paul,Christine L %A Boyes,Allison W %A O'Brien,Lorna %A Baker,Amanda L %A Henskens,Frans A %A Roos,Ian %A Clinton-McHarg,Tara %A Bellamy,Douglas %A Colburn,Glenda %A Rose,Shiho %A Cox,Martine E %A Fradgley,Elizabeth A %A Baird,Hannah %A Barker,Daniel %+ Priority Research Centre for Health Behaviour, School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan,, Australia, 61 2 4042 0693, chris.paul@newcastle.edu.au %K health information %K lung cancer %K telephone counseling %K psychological distress %K randomized controlled trial (RCT) %K telemedicine %D 2016 %7 26.10.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Community-based services such as telephone support lines can provide valuable informational, emotional, and practical support for cancer patients via telephone- or Web-based (live chat or email) platforms. However, very little rigorous research has examined the efficacy of such services in improving patient outcomes. Objective: This study will determine whether: proactive telephone or Web-delivered support produces outcomes superior to printed information; and Web-delivered support produces outcomes comparable to telephone support. Methods: A consecutive sample of 501 lung cancer outpatients will be recruited from 50 Australian health services to participate in a patient-randomized controlled trial (RCT). Eligible individuals must: be 18 years or older; have received a lung cancer diagnosis (including mesothelioma) within the previous 4 months; have an approximate life expectancy of at least 6 months; and have Internet access. Participants will be randomly allocated to receive: (1) an information booklet, (2) proactive telephone support, or (3) proactive Web support, chat, and/or email. The primary patient outcomes will be measured by the General Health Questionnaire (GHQ-12) and Health Education and Impact Questionnaire (heiQ) at 3 and 6 months post recruitment. The acceptability of proactive recruitment strategies will also be assessed. Results: It is hypothesized that participants receiving telephone or Web support will report reduced distress (GHQ-12 scores that are 0.3 standard deviations (SD) lower) and greater self-efficacy (heiQ scores that are 0.3 SDs higher) than participants receiving booklets. Individuals receiving Web support will report heiQ scores within 0.29 SDs of individuals receiving telephone support. Conclusions: If proven effective, electronic approaches such as live-chat and email have the potential to increase the accessibility and continuity of supportive care delivered by community-based services. This evidence may also inform the redesigning of helpline-style services to be effective and responsive to patient needs. %M 27784648 %R 10.2196/resprot.6248 %U http://www.researchprotocols.org/2016/4/e202/ %U https://doi.org/10.2196/resprot.6248 %U http://www.ncbi.nlm.nih.gov/pubmed/27784648 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e178 %T Development of a Mobile Phone-Based Weight Loss Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Protocol and Early Results From the PilAm Go4Health Randomized Controlled Trial %A Bender,Melinda Sarmiento %A Santos,Glenn-Milo %A Villanueva,Carissa %A Arai,Shoshana %+ School of Nursing, Department of Family Health Care Nursing, University of California San Francisco, 2 Koret Way, N431C, Box 0606, San Francisco, CA, 94143, United States, 1 415 502 5668, melinda.bender@ucsf.edu %K randomized controlled trial %K lifestyle intervention %K weight loss %K Filipinos %K type 2 diabetes %K culturally adapted %K Asian Americans %D 2016 %7 08.09.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Filipino Americans are the second largest Asian subgroup in the United States, and were found to have the highest prevalence of obesity and type 2 diabetes (T2D) compared to all Asian subgroups and non-Hispanic whites. In addition to genetic factors, risk factors for Filipinos that contribute to this health disparity include high sedentary rates and high fat diets. However, Filipinos are seriously underrepresented in preventive health research. Research is needed to identify effective interventions to reduce Filipino diabetes risks, subsequent comorbidities, and premature death. Objective: The overall goal of this project is to assess the feasibility and potential efficacy of the Filipino Americans Go4Health Weight Loss Program (PilAm Go4Health). This program is a culturally adapted weight loss lifestyle intervention, using digital technology for Filipinos with T2D, to reduce their risk for metabolic syndrome. Methods: This study was a 3-month mobile phone-based pilot randomized controlled trial (RCT) weight loss intervention with a wait list active control, followed by a 3-month maintenance phase design for 45 overweight Filipinos with T2D. Participants were randomized to an intervention group (n=22) or active control group (n=23), and analyses of the results are underway. The primary outcome will be percent weight change of the participants, and secondary outcomes will include changes in waist circumference, fasting plasma glucose, glycated hemoglobin A1c, physical activity, fat intake, and sugar-sweetened beverage intake. Data analyses will include descriptive statistics to describe sample characteristics and a feasibility assessment based on recruitment, adherence, and retention. Chi-square, Fisher's exact tests, t-tests, and nonparametric rank tests will be used to assess characteristics of randomized groups. Primary analyses will use analysis of covariance and linear mixed models to compare primary and secondary outcomes at 3 months, compared by arm and controlled for baseline levels. Results: Recruitment was completed in January, 2016, and participant follow-up continued through June, 2016. At baseline, mean age was 57 years, 100% (45/45) of participants self-identified as Filipinos, and the cohort was comprised of 17 males and 28 females. Overall, participants were obese with a baseline mean body mass index of 30.2 kg/m2 (standard deviation 4.9). The majority of participants were immigrants (84%, 38/45), with 47% (21/45) living in the United States for more than 10 years. One third of all participants (33%, 15/45) had previously used a pedometer. Conclusions: This study will provide preliminary evidence to determine if the PilAm Go4Health weight loss lifestyle intervention is feasible, and if the program demonstrates potential efficacy to reduce risks for metabolic syndrome in Filipinos with T2D. Positive results will lend support for a larger RCT to evaluate the effectiveness of the PilAm Go4Health intervention for Filipinos. ClinicalTrial: ClinicalTrials.gov: NCT02290184; https://clinicaltrials.gov/ct2/show/NCT02290184 (Archived at http://www.webcitation.org/6k1kUqKSP) %M 27608829 %R 10.2196/resprot.5836 %U http://www.researchprotocols.org/2016/3/e178/ %U https://doi.org/10.2196/resprot.5836 %U http://www.ncbi.nlm.nih.gov/pubmed/27608829 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e170 %T Protocol for a Randomized Controlled Trial Evaluating Mobile Text Messaging to Promote Retention and Adherence to Antiretroviral Therapy for People Living With HIV in Burkina Faso %A Wagner,Natascha %A Ouedraogo,Denis %A Artavia-Mora,Luis %A Bedi,Arjun %A Thiombiano,Boundia Alexandre %+ International Institute of Social Studies, Erasmus University Rotterdam, Kortenaerkade 12, The Hage, 2518AX, Netherlands, 31 0704260 ext 574, wagner@iss.nl %K HIV %K PLHIV %K mHealth %K SMS %K RCT %K developing countries %D 2016 %7 17.08.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Retention in care and adherence to antiretroviral therapy (ART) among people living with human immunodeficiency virus (PLHIV) is a critical challenge in many African countries including Burkina Faso. Delivering text messaging (short message service, SMS) interventions through mobile phones may help facilitate health service delivery and improve patient health. Despite this potential, no evaluations have been delivered for national scale settings to demonstrate the impact of mobile health (mHealth) for PLHIV. Objectives: This study aims to test the impact of SMS text messaging reminders for PLHIV in Burkina Faso, who are under ART. The evaluation identifies whether patients who receive SMS text messages are more likely to (1) retain in care (measured as a dichotomous variable), (2) adhere to antiretroviral regimens (measured as the number of doses missed in the past 7 days), and (3) experience slower disease progression (measured with T-lymphocytes cells). The second objective is to assess its effects on the frequency of health center visits, physical and psychosocial health, nutrition and whether the type of message (text vs image) and frequency (weekly vs semiweekly) have differential impacts including the possibility of message fatigue over time. Methods: This 24-month, wide-scale intervention implements a randomized controlled trial (RCT) to evaluate the impact of four variants of a mHealth intervention versus a control group. Our sample comprises adult patients (>15 years of age) undergoing antiretroviral therapy with access to mobile phone services. Multivariate regression analysis will be used to analyze the effect of the intervention on the study population. Data collection is done at baseline and three follow-up waves 6, 12, and 24 months after the intervention starts. Results: The targeted 3800 patients were recruited between February 2015 and May 2015. But political uncertainty delayed the launch of the intervention until October 2015. Data analysis has not yet started. The first follow-up data collection started in April 2016. To the best of our knowledge, this is the first research that explores the effects of mobile message reminders using a wide-spread sample across an entire nation over a 2-year horizon, especially in a Francophone African country. Conclusions: We hypothesize that the interventions have a positive impact on retention in care and adherence to ART schemes and that a more sluggish disease progression will be observed in the short run. However, these benefits may fade out in the long run. The study expects to advance the research on how long mHealth interventions remain effective and when fatigue sets in the context of wide-scale interventions. This information will be useful in designing future wide-scale mHealth interventions in developing countries. %M 27535717 %R 10.2196/resprot.5823 %U http://www.researchprotocols.org/2016/3/e170/ %U https://doi.org/10.2196/resprot.5823 %U http://www.ncbi.nlm.nih.gov/pubmed/27535717 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e163 %T Telemedicine for Gestational Diabetes Mellitus (TeleGDM): A Mixed-Method Study Protocol of Effects of a Web-Based GDM Support System on Health Service Utilization, Maternal and Fetal Outcomes, Costs, and User Experience %A Rasekaba,Tshepo Mokuedi %A Lim,Kwang %A Blackberry,Irene %A Gray,Kathleen %A Furler,John %+ Department of General Practice, The University of Melbourne, 200 Berkeley Street, Carlton,, Australia, 61 3 8344 7276, tshepo.rasekaba@unimelb.edu.au %K gestational diabetes %K telemedicine %K Internet %K electronic personal health record %D 2016 %7 09.08.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Women with insulin-treated gestational diabetes mellitus (GDM) require close monitoring and support to manage their diabetes. Recent changes to the diagnostic criteria have implications for service provision stemming from increased prevalence, suggesting an increased burden on health services in the future. Telemedicine may augment usual care and mitigate service burdens without compromising clinical outcomes but evidence in GDM is limited. Objective: The Telemedicine for Gestational Diabetes Mellitus (TeleGDM) trial aims to explore the use of telemedicine in supporting care and management of women with GDM treated with insulin. Methods: The TeleGDM is a mixed-methods study comprising an exploratory randomized controlled trial (RCT) and a qualitative evaluation using semistructured interviews. It involves women with insulin-treated GDM who are up to 35 weeks gestation. Participating patients (n=100) are recruited face-to-face in outpatient GDM clinics at an outer metropolitan tertiary hospital with a culturally diverse catchment and a regional tertiary hospital. The second group of participants (n=8) comprises Credentialed Diabetes Educator Registered Nurses involved in routine care of the women with GDM at the participating clinics. The RCT involves use of a Web-based patient-controlled personal health record for GDM data sharing between patients and clinicians compared to usual care. Outcomes include service utilization, maternal and fetal outcomes (eg, glycemic control, 2nd and 3rd trimester fetal size, type of delivery, baby birth weight), diabetes self-efficacy, satisfaction, and costs. Semistructured interviews will be used to examine user experiences and acceptability of telemedicine. Results: The trial recruitment is currently underway. Results are expected by the end of 2016 and will be reported in a follow-up paper. Conclusions: Innovative use of technology in supporting usual care delivery in women with GDM may facilitate timely access to GDM monitoring data and mitigate care burdens without compromising maternal and fetal outcomes. The intervention may potentially reduce health service utilization. Trial Registration: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000934640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366740 (Archived by WebCite® at http://www.webcitation.org/6jRiqzjSv). %M 27507708 %R 10.2196/resprot.6044 %U http://www.researchprotocols.org/2016/3/e163/ %U https://doi.org/10.2196/resprot.6044 %U http://www.ncbi.nlm.nih.gov/pubmed/27507708 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e158 %T MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial %A Rossing,Emil %A Ravn,Henrik %A Batista,Celso Soares Pereira %A Rodrigues,Amabelia %+ OPEN, Odense Patient data Explorative Network, Odense University Hospital, Department of Clinical Research, University of Southern Denmark, J. B. Winsløws Vej 9 a, 3. floor, Odense C, DK-5000, Denmark, 45 61779344, emro@ssi.dk %K mHealth %K eHealth %K SMS reminders %K voice reminders %K Guinea-Bissau, ODK %K Africa %K RapidSMS %K health systems strengthening %K randomized controlled trial %K measles %K immunization %D 2016 %7 27.07.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Recent studies have revealed a low measles vaccination (MV) rate in the Republic of Guinea-Bissau (West Africa) that has not increased in accordance with the increasing coverage of other vaccinations. Measles is the deadliest of all childhood rash/fever illnesses and spreads easily, implying that if the vaccination coverage is declining there is a significant risk of new measles outbreaks [27]. Meanwhile, mobile health (mHealth; the use of mobile phones for health interventions) has generated much enthusiasm, and shown potential in improving health service delivery in other contexts. Objective: The aim of this study is to evaluate the efficiency of mHealth as a tool for improving MV coverage while contributing to the mHealth evidence base. Methods: This study will take place at three health centers in different regions of Guinea-Bissau. Participants, defined as mothers of the children receiving the MV, will be enrolled when they arrive with their children at the health center to receive the Bacillus Calmette-Guérin vaccination, usually within one month of the child’s birth. Enrolment will continue until a study population of 990 children has been reached. The participants will be randomly assigned to a control arm or one of two intervention arms. Each of the three groups will have 330 participants, distributed equally between health centers. Participants in the first intervention arm will receive a scheduled short message service (SMS) text message reminding them of the MV. Participants in the second intervention arm will receive a voice call in addition to the SMS message, while the control arm will receive no interventions. The MV is scheduled to be administered at 9 months of age. Although the vaccine would still be effective after 12 months, local policy in Guinea-Bissau prevents children aged >12 months from receiving the vaccination, and thus the study will follow-up with participants after the children reach 12 months of age. Children who have not yet received the MV will be offered vaccination by the project group. Results: The study will analyze the efficiency of the intervention by determining its overall effect on MV coverage and timeliness when children reach 12 months of age. The main analysis will be stratified by intervention group, health center, level of education, ethnic group, and role of the person receiving the text messages (eg, mother, father, other family member). Secondary outcomes include the average number of health center visits (with intention to obtain the MV) required before successful administration. Conclusions: Despite the rapid proliferation of mHealth projects, only a small number have been evaluated in terms of direct links to health outcomes. This gap in knowledge requires solid evidence on which policy-makers can base decisions. This study aims to produce significant knowledge about mHealth implementation within a Sub-Saharan context while creating data-supported evidence. Trial Registration: Clinicaltrials.gov: NCT02662595; https://clinicaltrials.gov/ct2/show/NCT02662595 (Archived by WebCite at http://www.webcitation.org/6jH8YiSjY) %M 27466046 %R 10.2196/resprot.5968 %U http://www.researchprotocols.org/2016/3/e158/ %U https://doi.org/10.2196/resprot.5968 %U http://www.ncbi.nlm.nih.gov/pubmed/27466046 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e155 %T Voice-Message–Based mHealth Intervention to Reduce Postoperative Penetrative Sex in Recipients of Voluntary Medical Male Circumcision in the Western Cape, South Africa: Protocol of a Randomized Controlled Trial %A Thomsen,Sarah C %A Skinner,Donald %A Toefy,Yoesrie %A Esterhuizen,Tonya %A McCaul,Michael %A Petzold,Max %A Diwan,Vinod %+ Global Health, Department of Public Health Sciences, Karolinska Institutet, Jarvstigen 4, Solna,, Sweden, 46 7 0280 6979, sarah.thomsen@ki.se %K protocol %K RCT %K male circumcision %K HIV %K mHealth %K VMMC %D 2016 %7 26.07.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There is an increased risk of transmission of sexually transmitted infections (STIs), including HIV, in the postoperative period after receiving voluntary medical male circumcision (VMMC). In South Africa, over 4 million men are being targeted with VMMC services but the health system is not able to offer quality counseling. More innovative strategies for communicating with and altering behavior in men and their partners in the postoperative period after VMMC are needed. Objective: This paper presents a study protocol to test the effectiveness of an mHealth intervention designed to task-shift behavior change communication from health care personnel to an automated phone message system, encouraging self-care. Methods: A single-blind, randomized controlled trial will be used. A total of 1188 participants will be recruited by nurses or clinicians at clinics in the study districts that have a high turnover of VMMC clients. The population will consist of men aged 18 years and older who indicate at the precounseling session that they possess a mobile phone and consent to participating in the study. Consenting participants will be randomized into either the control or intervention arm before undergoing VMMC. The control arm will receive the standard of care (pre- and postcounseling). The intervention arm will received standard of care and will be sent 38 messages over the 6-week recovery period. Patients will be followed up after 42 days. The primary outcome is self-reported sexual intercourse during the recovery period. Secondary outcomes include nonpenetrative sexual activity, STI symptoms, and perceived risk of acquiring HIV. Analysis will be by intention-to-treat. Results: Enrollment is completed. Follow-up is ongoing. Loss to follow-up is under 10%. No interim analyses have been conducted. Conclusions: The intervention has the potential of reducing risky sexual behavior after VMMC. The platform itself can be used for many other areas of health that require task shifting to patients for better efficiency and access. Trial Registration: Pan-African Clinical Trial Registry: PACTR201506001182385 %M 27460771 %R 10.2196/resprot.5958 %U http://www.researchprotocols.org/2016/3/e155/ %U https://doi.org/10.2196/resprot.5958 %U http://www.ncbi.nlm.nih.gov/pubmed/27460771 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e148 %T Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo) %A Iversen,Marjolein M %A Espehaug,Birgitte %A Hausken,Marie F %A Graue,Marit %A Østbye,Truls %A Skeie,Svein %A Cooper,John G %A Tell,Grethe S %A Günther,Bodo Erhardt %A Dale,Håvard %A Smith-Strøm,Hilde %A Kolltveit,Beate-Christin H %A Kirkevold,Marit %A Rokne,Berit %+ Centre for Evidence-Based Practice, Faculty of Health and Social Sciences, Bergen University College, Pb 7030, Bergen,, Norway, 47 555 87 500 ext 5815, miv@hib.no %K diabetes %K diabetic foot %K foot ulcer %K telemedicine %K randomized controlled trial %K primary care %K delivery of health care, integrated %K complex intervention %K patient-reported outcomes %K Norway %K cluster RCT %D 2016 %7 18.07.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: This paper presents the protocol for an ongoing study to evaluate a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Diabetes-related foot ulcers represent challenges for patients and the health services. The large increase in the prevalence of diabetes, combined with the aging population, means that the absolute number of patients with diabetes-related foot ulcers is likely to continue to increase. Health care services therefore need to provide close clinical follow-up care for people with diabetes both in primary and specialist care. Information and communication technologies may enable more integrated treatment and care pathways across organizational boundaries. However, we lack knowledge about the effect of telemedicine follow-up and how such services can be optimally organized. Objective: To present the design and methods of a study evaluating a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Methods: The study is designed as a cluster randomized controlled trial (noninferiority trial) involving municipalities or municipality districts (clusters) belonging to one clinical site in Western Norway. The study includes patients with type 1 and type 2 diabetes presenting with a new foot ulcer at the initial visit to the clinic. Patients in the intervention group receive telemedicine follow-up care in the community. The key ingredient in the intervention is the close integration between health care levels. The intervention is facilitated by the use of an interactive wound platform consisting of a Web-based ulcer record combined with a mobile phone, enabling counseling and communication between nurses in the community and specialist health care. Patients in the control group receive standard hospital outpatient care. The primary endpoint in the trial is healing time; secondary outcomes include amputation and death, patient-reported outcome measures, and follow-up data on the recurrence of foot ulcers. In addition, qualitative substudies are being performed to provide a more comprehensive evaluation of the ongoing processes during the trial with the patients in the intervention and control groups and those health care professionals either working in primary care or in specialist care delivering the intervention. Results: The project has been funded. The inclusion of patients started in September 2012. Because recruitment goals were not met in the initial period, two more clinical sites have been included to meet sample size requirements. Patient recruitment will continue until June 2016. Data collection in the qualitative substudies has been completed. Conclusions: This telemedicine trial operates in a novel setting and targets patients with diabetes-related foot ulcers during a 12-month follow-up period. The trial addresses whether integrated care using telemedicine between primary and specialist health care can be an equivalent alternative to standard outpatient care. Trial Registration: ClinicalTrials.gov NCT01710774; https://clinicaltrials.gov/ct2/show/NCT01710774 (Archived by WebCite at http://www.webcitation.org/6im6KfFov). %M 27430301 %R 10.2196/resprot.5646 %U http://www.researchprotocols.org/2016/3/e148/ %U https://doi.org/10.2196/resprot.5646 %U http://www.ncbi.nlm.nih.gov/pubmed/27430301 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e107 %T Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial %A Padwal,Raj %A McAlister,Finlay Aleck %A Wood,Peter William %A Boulanger,Pierre %A Fradette,Miriam %A Klarenbach,Scott %A Edwards,Alun L %A Holroyd-Leduc,Jayna M %A Alagiakrishnan,Kannayiram %A Rabi,Doreen %A Majumdar,Sumit Ranjan %+ Department of Medicine, University of Alberta, 5-134A Clinical Sciences Bldg, 11350 83 Ave, Edmonton, AB, T6G2G3, Canada, 1 7804923686, rpadwal@ualberta.ca %K blood pressure %K hypertension %K seniors %K telemonitoring %K randomized controlled trial %K case management %D 2016 %7 24.06.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving “optimal BP control” (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring—the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. Objective: To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with “enhanced usual care” in community-dwelling seniors with diabetes and hypertension. Methods: A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors’ residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Results: Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers. Conclusion: The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada. Trial Registration: Clinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc) %M 27343147 %R 10.2196/resprot.5775 %U http://www.researchprotocols.org/2016/2/e107/ %U https://doi.org/10.2196/resprot.5775 %U http://www.ncbi.nlm.nih.gov/pubmed/27343147 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e131 %T A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial %A Glasner-Edwards,Suzette %A Patrick,Kevin %A Ybarra,Michele L %A Reback,Cathy J %A Rawson,Richard A %A Chokron Garneau,Helene %A Chavez,Kathryn %A Venegas,Alexandra %+ Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, 11075 Santa Monica Blvd, Suite 200, Los Angeles, CA,, United States, 1 310 267 5206, sglasner@ucla.edu %K SMS %K medication adherence %K HIV %K relapse prevention %K text messaging %K CBT %K ART %D 2016 %7 24.06.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Objective: Mobile phone–based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. Methods: With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. Results: The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. Conclusions: This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users. %M 27341852 %R 10.2196/resprot.5407 %U http://www.researchprotocols.org/2016/2/e131/ %U https://doi.org/10.2196/resprot.5407 %U http://www.ncbi.nlm.nih.gov/pubmed/27341852 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e110 %T Novel Use of Hydroxyurea in an African Region With Malaria: Protocol for a Randomized Controlled Clinical Trial %A Anyanwu,Juliana N %A Williams,Olatundun %A Sautter,Casey L %A Kasirye,Phillip %A Hume,Heather %A Opoka,Robert O %A Latham,Teresa %A Ndugwa,Christopher %A Ware,Russell E %A John,Chandy C %+ Indiana University School of Medicine, 1044 W. Walnut St, R4 402D, Indianapolis, IN, 46202, United States, 1 3172748940, chjohn@iu.edu %K sickle cell anemia %K hydroxyurea %K malaria %D 2016 %7 23.06.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sickle cell anemia (SCA), one of most prevalent monogenic diseases worldwide, is caused by a glutamic acid to valine substitution on the beta globin protein of hemoglobin, which leads to hemolytic anemia. Hydroxyurea, the only disease-modifying therapy approved by the Food and Drug Administration for SCA, has proven to be a viable therapeutic option for SCA patients in resource-rich settings, given clinical improvements experienced while taking the medication and its once-daily oral dosing. Significant studies have demonstrated its safety and clinical efficacy among children and adults in developed countries. In Sub-Saharan Africa, however, the risk of malaria, hematologic toxicities, and safety of hydroxyurea in children with SCA living in malaria-endemic areas are unknown. Objectives: Study objectives include determining the incidence of malaria in SCA patients taking hydroxyurea versus placebo; establishing the frequency of hematologic toxicities and adverse events (AEs) in children with SCA treated with hydroxyurea versus placebo; and defining the relationships between hydroxyurea treatment and fetal hemoglobin, soluble intracellular adhesion molecule-1, and nitric oxide levels, and between levels of these factors and risk of subsequent malaria. Methods: Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM, NCT01976416) is a prospective, randomized, placebo-controlled, double-blinded phase III trial to compare risk of malaria with oral hydroxyurea versus placebo. Children will be recruited from the Mulago Hospital Sickle Cell Clinic in Kampala, Uganda. Results: Two hundred Ugandan children aged between 1.00 and 3.99 years with confirmed SCA will be randomized into treatment groups by order of entry in the study, based on a predetermined blinded randomization list. The primary outcome of the trial is malaria incidence in the 2 study groups, defined as episodes of clinical malaria occurring over the 1-year randomized study treatment period. Conclusion: NOHARM will be the first prospective randomized, placebo-controlled clinical trial investigating the use of hydroxyurea for children with SCA in a malaria-endemic region within Africa. The results of this trial have the potential to significantly advance understanding of how to safely and effectively use hydroxyurea in children with SCA in malaria-endemic areas. Trial Registration: Clinicaltrials.gov NCT01976416; https://clinicaltrials.gov/ct2/show/NCT01976416 (Archived by WebCite at http://www.webcitation.org/6hmoilZnp) %M 27339303 %R 10.2196/resprot.5599 %U http://www.researchprotocols.org/2016/2/e110/ %U https://doi.org/10.2196/resprot.5599 %U http://www.ncbi.nlm.nih.gov/pubmed/27339303 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e125 %T Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial %A Hirshfield,Sabina %A Downing Jr,Martin J %A Parsons,Jeffrey T %A Grov,Christian %A Gordon,Rachel J %A Houang,Steven T %A Scheinmann,Roberta %A Sullivan,Patrick S %A Yoon,Irene S %A Anderson,Ian %A Chiasson,Mary Ann %+ Public Health Solutions, Research and Evaluation, 40 Worth Street, 5th Floor, New York, NY, 10013, United States, 1 6466196676, SHirshfield@healthsolutions.org %K eHealth interventions %K GBMSM %K HIV prevention %K HIV disclosure %K randomized controlled trial %K videos %D 2016 %7 17.06.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. Objective: To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Methods: Sex Positive![+] is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Results: Participant recruitment began in June 2015 and ended in December 2015. Conclusions: This protocol describes the underlying theoretical framework and measures, study design, recruitment challenges, and antifraud measures for an online, video-based randomized controlled trial that has the potential to decrease HIV transmission risk behaviors among HIV-positive GBMSM who struggle with ART adherence. The Sex Positive![+] intervention allows for participation through multiple Internet-based mediums and has the potential to reach and engage a broader population of HIV-positive GBMSM who are virally unsuppressed. ClinicalTrial: ClinicalTrials.gov NCT02023580; https://clinicaltrials.gov/ct2/show/NCT02023580 (Archived by WebCite at http://www.webcitation.org/6iHzA8wRG) %M 27315764 %R 10.2196/resprot.5554 %U http://www.researchprotocols.org/2016/2/e125/ %U https://doi.org/10.2196/resprot.5554 %U http://www.ncbi.nlm.nih.gov/pubmed/27315764 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e127 %T Using Behavioral Intervention Technologies to Help Low-Income and Latino Smokers Quit: Protocol of a Randomized Controlled Trial %A Muñoz,Ricardo F %A Bunge,Eduardo L %A Barrera,Alinne Z %A Wickham,Robert E %A Lee,Jessica %+ Palo Alto University, 1791 Arastradero, Palo Alto, CA,, United States, 1 800 818 6136, rmunoz@paloaltou.edu %K smoking cessation %K Web app %K human-centered design %K recruitment %K dissemination %D 2016 %7 14.06.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: The Institute for International Internet Interventions for Health at Palo Alto University proposes to develop digital tools specifically to help low-income English- and Spanish-speaking smokers to quit. Individuals from lower-income countries and those with lower social status quit at lower rates than those from high-income countries and those with higher social status. Objective: We plan to launch a project designed to test whether a mobile-based digital intervention designed with systematic input from low-income English- and Spanish-speaking smokers from a public-sector health care system can significantly improve its acceptability, utilization, and effectiveness. Methods: Using human-centered development methods, we will involve low-income patients in the design of a Web app/text messaging tool. We will also use their input to improve our recruitment and dissemination strategies. We will iteratively develop versions of the digital interventions informed by our human-centered approach. The project involves three specific aims: (1) human-centered development of an English/Spanish smoking cessation web app, (2) improvement of dissemination strategies, and (3) evaluation of resulting smoking cessation web app. We will develop iterative versions of a digital smoking cessation tool that is highly responsive to the needs and preferences of the users. Input from participants will identify effective ways of reaching and encouraging low-income English- and Spanish-speaking smokers to use the digital smoking cessation interventions to be developed. This information will support ongoing dissemination and implementation efforts beyond the grant period. We will evaluate the effectiveness of the successive versions of the resulting stop smoking Web app by an online randomized controlled trial. Increased effectiveness will be defined as increased utilization of the Web app and higher abstinence rates than those obtained by a baseline usual care Web app. Results: Recruitment will begin January 2016, the study is intended to be completed by summer 2018, and the results should be available by fall 2019. Conclusions: This study will provide useful knowledge in developing, testing, and disseminating mobile-based interventions for low-income smokers. ClinicalTrial: ClinicalTrials.gov NCT02666482; https://clinicaltrials.gov/ct2/show/NCT02666482 (Archived by WebCite at http://www.webcitation.org/6gtcwaT28) %M 27302623 %R 10.2196/resprot.5355 %U http://www.researchprotocols.org/2016/3/e189/ %U https://doi.org/10.2196/resprot.5355 %U http://www.ncbi.nlm.nih.gov/pubmed/27302623 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e103 %T An Internet-Based Intervention to Promote Alcohol-Related Attitudinal and Behavioral Change Among Adolescents: Protocol of a Cluster Randomized Controlled Trial %A Ip,Patrick %A Chan,Ko-Ling %A Chow,Chun-Bong %A Lam,Tai-Hing %A Ho,Sai-Yin %A Wong,Wilfred Hing-Sang %A Wong,Margaret Fung-Yee %+ The University of Hong Kong, Department of Paediatrics and Adolescent Medicine, 1/F, New Clinical Building, Queen Mary Hospital, Pokfulam, Hong Kong,, China (Hong Kong), 852 28198501, patricip@hku.hk %K Internet viral marketing %K attitude change %K behavioural change %K underage drinking %K risk behaviour %K Internet intervention %D 2016 %7 01.06.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Underage drinking is a prevalent risk behavior and common public health problem. Research shows that alcohol abuse not only affects the quality of life of drinkers themselves. The problems resulting from underage drinking pose substantial costs to society as well. The proposed study will address underage drinking with the use of an Internet campaign, which is a cost-effective way of tackling the problem. Objective: The aims of this study are to test the effectiveness of an online quiz competition in changing adolescents’ alcohol-related attitudes and behavior and to explore the feasibility of using Internet viral marketing to reach a significant number of adolescents. Methods: The study will constitute a cluster randomized controlled trial for 20 secondary schools (6720 Grade 7-9 students). Schools will be randomized to intervention or control arm with equal likelihood. Students in intervention schools will be invited to take part in the Internet campaign, whereas those in control schools will receive relevant promotional leaflets. Results: Alcohol-related attitude and behavior will be the primary outcome measures. The results of the proposed study will provide evidence on the efficacy of an Internet intervention in modifying adolescents’ attitudes and behavior and guide further investigation into the prevention of and intervention in such risk behaviors as underage drinking. The project was funded July 2015, enrollment started September 2015, and results are expected July 2017. Conclusions: With the Internet increasingly being recognized as a practical and cost-effective platform for health information delivery, the proposed Internet-based intervention is expected to be more effective in altering adolescents’ alcohol-related attitudes and behaviors than traditional health promotion. ClinicalTrial: ClinicalTrials.gov NCT02450344; https://clinicaltrials.gov/ct2/show/NCT02450344 (Archived by WebCite at http://www.webcitation.org/6heB2zMBD) %M 27252072 %R 10.2196/resprot.5001 %U http://www.researchprotocols.org/2016/2/e103/ %U https://doi.org/10.2196/resprot.5001 %U http://www.ncbi.nlm.nih.gov/pubmed/27252072 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e59 %T Testing Activity Monitors’ Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients %A Lewis,Zakkoyya H %A Ottenbacher,Kenneth J %A Fisher,Steve R %A Jennings,Kristofer %A Brown,Arleen F %A Swartz,Maria C %A Lyons,Elizabeth J %+ University of Texas Medical Branch, Division of Rehabilitation Sciences, 301 University Blvd, School of Health Professions Bldg room 2.252B, Galveston, TX, 77555, United States, 1 409 772 2576, zalewisp@utmb.edu %K physical activity %K cardiovascular disease %K prevention %K activity monitors %K technology %K primary care %K 5 A counseling %K intervention %D 2016 %7 29.04.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cardiovascular disease is the leading cause of mortality in the United States. Maintaining healthy levels of physical activity is critical to cardiovascular health, but many older adults are inactive. There is a growing body of evidence linking low motivation and inactivity. Standard behavioral counseling techniques used within the primary care setting strive to increase motivation, but often do not emphasize the key component of self-control. The addition of electronic activity monitors (EAMs) to counseling protocols may provide more effective behavior change and increase overall motivation for exercise through interactive self-monitoring, feedback, and social support from other users. Objective: The objective of the study is to conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (n=40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Methods: Throughout the intervention, we will test its feasibility and acceptability, the change in primary outcomes (cardiovascular risk and physical activity), and the change in secondary outcomes (adherence, weight and body composition, health status, motivation, physical function, psychological feelings, and self-regulation). Upon completion of the intervention, we will also conduct focus groups with the participants and with primary care stakeholders. Results: The study started recruitment in October 2015 and is scheduled to be completed by October 2016. Conclusions: This project will lay the groundwork and establish the infrastructure for intervention refinement and ultimately translation within the primary care setting in order to prevent cardiovascular disease on a population level. Trial Registration: ClinicalTrails.gov NCT02554435; https://clinicaltrials.gov/ct2/show/NCT02554435 (Archived by WebCite at http://www.webcitation/6fUlW5tdT) %M 27129602 %R 10.2196/resprot.5454 %U http://www.researchprotocols.org/2016/2/e59/ %U https://doi.org/10.2196/resprot.5454 %U http://www.ncbi.nlm.nih.gov/pubmed/27129602 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e53 %T Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: Protocol for a Randomized Study Funded by the US Department of Veterans Affairs Health Services Research and Development Program %A Piette,John D %A Krein,Sarah L %A Striplin,Dana %A Marinec,Nicolle %A Kerns,Robert D %A Farris,Karen B %A Singh,Satinder %A An,Lawrence %A Heapy,Alicia A %+ Center for Managing Chronic Disease, Department of Health Behavior and Health Education, University of Michigan School of Public Health, 1415 Washington Heights, Ann Arbor, MI, 48109, United States, 1 734 763 1457, jpiette@umich.edu %K Medical Informatics %K mhealth %K artificial intelligence %K comparative effectiveness %D 2016 %7 07.04.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cognitive behavioral therapy (CBT) is one of the most effective treatments for chronic low back pain. However, only half of Department of Veterans Affairs (VA) patients have access to trained CBT therapists, and program expansion is costly. CBT typically consists of 10 weekly hour-long sessions. However, some patients improve after the first few sessions while others need more extensive contact. Objective: We are applying principles from “reinforcement learning” (a field of artificial intelligence or AI) to develop an evidence-based, personalized CBT pain management service that automatically adapts to each patient’s unique and changing needs (AI-CBT). AI-CBT uses feedback from patients about their progress in pain-related functioning measured daily via pedometer step counts to automatically personalize the intensity and type of patient support. The specific aims of the study are to (1) demonstrate that AI-CBT has pain-related outcomes equivalent to standard telephone CBT, (2) document that AI-CBT achieves these outcomes with more efficient use of clinician resources, and (3) demonstrate the intervention’s impact on proximal outcomes associated with treatment response, including program engagement, pain management skill acquisition, and patients’ likelihood of dropout. Methods: In total, 320 patients with chronic low back pain will be recruited from 2 VA healthcare systems and randomized to a standard 10 sessions of telephone CBT versus AI-CBT. All patients will begin with weekly hour-long telephone counseling, but for patients in the AI-CBT group, those who demonstrate a significant treatment response will be stepped down through less resource-intensive alternatives including: (1) 15-minute contacts with a therapist, and (2) CBT clinician feedback provided via interactive voice response calls (IVR). The AI engine will learn what works best in terms of patients’ personally tailored treatment plans based on daily feedback via IVR about their pedometer-measured step counts, CBT skill practice, and physical functioning. Outcomes will be measured at 3 and 6 months post recruitment and will include pain-related interference, treatment satisfaction, and treatment dropout. Our primary hypothesis is that AI-CBT will result in pain-related functional outcomes that are at least as good as the standard approach, and that by scaling back the intensity of contact that is not associated with additional gains in pain control, the AI-CBT approach will be significantly less costly in terms of therapy time. Results: The trial is currently in the start-up phase. Patient enrollment will begin in the fall of 2016 and results of the trial will be available in the winter of 2019. Conclusions: This study will evaluate an intervention that increases patients’ access to effective CBT pain management services while allowing health systems to maximize program expansion given constrained resources. %M 27056770 %R 10.2196/resprot.4995 %U http://www.researchprotocols.org/2016/2/e53/ %U https://doi.org/10.2196/resprot.4995 %U http://www.ncbi.nlm.nih.gov/pubmed/27056770 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e39 %T Development, Validation, and Evaluation of Web-Based Iranian Diabetic Personal Health Record: Rationale for and Protocol of a Randomized Controlled Trial %A Azizi,Amirabbas %A Aboutorabi,Robab %A Mazloum-Khorasani,Zahra %A Afzal-Aghaea,Monavar %A Tara,Mahmood %+ Faculty of Medicine, Department of Medical Informatics, Mashhad University of Medical Sciences, Pardis Daneshgah, Park Square, Mashhad, 917-7948-564, Islamic Republic Of Iran, 98 5138002429, taram@mums.ac.ir %K diabetes mellitus %K type 2 %K personal health record %K web-based %K Iran %D 2016 %7 10.03.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetes is one of the four main types of noncommunicable or chronic diseases. Iran is among the countries with the highest incidence of diabetic patients. A study demonstrated that the collection of diabetic data is neither organized nor standardized. There is currently no instance of electronic personal health records particularly used for diabetic patients in Iran, hence the need for one, which will be useful for self-care of diabetic patients. Objective: The objective of the study is to examine the impact of a Web-based diabetic personal health record (DPHR) on the self-care status of diabetic patients as compared with the control group. Methods: This study is a randomized control trial, which involves a systematic review of literature of the preferred data elements regarding a DPHR, and reevaluating the results with the opinions of local endocrinologists. Inclusion criteria were as follows: type 2 diabetic patients between 20-70 of age who live in the Mashhad City and having the disease for at least one year. The sample size is 72 people that were randomly assigned to the control and intervention groups. The participants in the intervention group were allowed access to the Web-based DPHR system, while those in the control group will continue to receive the usual care for 4 months. The study primary outcome measures include self-care status of participants and planned visit adherence. Results: At the moment, there is an ongoing recruitment of participants, and preliminary results will be published in early 2016. Conclusions: We expect the final DPHR model, developed and tested during this study, to help diabetic patients to actively participate in their care management process, and also to empower the physician in providing more quality informed decisions regarding their patients. Trial Registration: irct.ir IRCT2013082914522N1; http://www.irct.ir/searchresult.php?id=14522&number=1 (Archived by WebCite at http://www.webcitation.org/6cC4PCcau). %M 26964572 %R 10.2196/resprot.5201 %U http://www.researchprotocols.org/2016/1/e39/ %U https://doi.org/10.2196/resprot.5201 %U http://www.ncbi.nlm.nih.gov/pubmed/26964572 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e7 %T A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Randomized Clinical Trial Rationale and Protocol %A Fu,Mei Rosemary %A Axelrod,Deborah %A Guth,Amber %A Scagliola,Joan %A Rampertaap,Kavita %A El-Shammaa,Nardin %A Fletcher,Jason %A Zhang,Yan %A Qiu,Jeanna M %A Schnabel,Freya %A Hiotis,Karen %A Wang,Yao %A D'Eramo Melkus,Gail %+ College of Nursing, New York University, 433 First Avenue, 4th Fl, Rm 424, New York, NY, 10010, United States, 1 212 998 5314, mf67@nyu.edu %K pain %K ache %K soreness %K tenderness %K symptoms %K lymphedema %K breast cancer %K health behavior %K mHealth %D 2016 %7 21.01.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Despite current advances in cancer treatment, many breast cancer survivors still face long-term post-operative challenges as a result of suffering from daily pain and other distressing symptoms related to lymphedema, ie, abnormal accumulation of lymph fluid in the ipsilateral upper limb or body. Grounded in research-driven behavioral strategies, The-Optimal-Lymph-Flow is a unique Web- and mobile-based system focusing on self-care strategies to empower, rather than inhibit, how breast cancer survivors manage daily pain and symptoms. It features a set of safe, feasible, and easily-integrated-into-daily-routine exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal body mass index (BMI). Objective: To conduct a randomized clinical trial (RCT) to evaluate the efficacy of the Web- and mobile-based The-Optimal-Lymph-Flow system for managing chronic pain and symptoms related to lymphedema. The primary outcome includes pain reduction, and the secondary outcomes focus on symptom relief, limb volume difference by infra-red perometer, BMI, and quality of life (QOL) related to pain. We hypothesize that participants in the intervention group will have improved pain and symptom experiences, limb volume difference, body mass index, and QOL. Methods: A parallel RCT with a control-experimental, pre- and post-test, repeated-measures design is used in this study. A total of 120 patients will be randomized according to the occurrence of pain. Participants will be recruited face-to-face at the point of care during clinical visits. Participants in the intervention group will receive the Web- and mobile-based The-Optimal-Lymph-Flow intervention and will have access to and learn about the program during the first in-person research visit. Participants in the control group will receive the Web- and mobile-based Arm Precaution program and will have access to and learn about the program during the first in-person research visit. Participants will be encouraged to enhance their learning by accessing the program and following the daily exercises during the study period. Participants will have monthly online self-report of pain and symptoms at 4 and 8 weeks post-intervention. During the two in-person research visits prior to and 12 weeks post-intervention, participants will be measured for limb volume difference, BMI, and complete self-report of pain, symptoms, self-care behaviors, and QOL. Results: This trial is currently open for recruitment. The anticipated completion date for the study is July 2017. The primary endpoint for the study is absence or reduction of pain reported by the participants at week 12 post-intervention. Conclusions: The-Optimal-Lymph-Flow is a unique Web- and mobile-based self-care and patient-reported outcome system designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Patients learn self-care strategies from a Web- and mobile-based program and track their symptoms. The RCT will directly benefit all women treated for breast cancer who suffer from or at risk for pain and symptoms related to lymph fluid accumulation. Trial Registration: Clinicaltrials.gov NCT02462226; https://clinicaltrials.gov/ct2/show/NCT02462226 (Archived by WebCite at http://www.webcitation.org/6du4IupG5) %M 26795447 %R 10.2196/resprot.5104 %U http://www.researchprotocols.org/2017/1/e7/ %U https://doi.org/10.2196/resprot.5104 %U http://www.ncbi.nlm.nih.gov/pubmed/26795447 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e139 %T Mobile Phone Apps for University Students With Hazardous Alcohol Use: Study Protocol for Two Consecutive Randomized Controlled Trials %A Berman,Anne H %A Gajecki,Mikael %A Fredriksson,Morgan %A Sinadinovic,Kristina %A Andersson,Claes %+ Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Norra Stationsgatan 69, plan 7, Stockholm, 11364, Sweden, 46 704245360, anne.h.berman@ki.se %K randomized controlled trial, universities, alcohol abuse, prevention, mobile phone, eHealth, mHealth %D 2015 %7 22.12.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: About 50% of university students overconsume alcohol, and drinking habits in later adulthood are to some extent established during higher educational studies. Several studies have demonstrated that Internet-based interventions have positive effects on drinking habits among university students. Our recent study evaluated two mobile phone apps targeting drinking choices at party occasions via personalized feedback on estimated blood alcohol concentration (eBAC) for students with hazardous drinking. No changes in drinking parameters were found over a seven-week period apart from an increase in number of drinking occasions among men for one of the apps tested. Up to 30% of the study participants drank at potentially harmful levels: higher than the national recommended number of standard drinks per week (a maximum of 9 for women and 14 for men) in Sweden. Objective: (1) To evaluate improved versions of the two mobile phone apps tested in our prior trial, in a new, 3-armed randomized controlled trial among university students with at least hazardous drinking habits according to the Alcohol Use Disorders Identifications Test (AUDIT; Study 1). (2) After 6 weeks, to target study participants showing alcohol consumption higher than the national recommended levels for standard drinks per week by offering them participation in a second, 2-armed randomized trial evaluating an additional mobile phone app with skill enhancement tasks (Study 2). (3) To follow participants at 6, 12 and 18 weeks after recruitment to Study 1 and at 6 and 12 weeks after recruitment to Study 2. Methods: Two randomized controlled trials are conducted. Study 1: Students are recruited at four Swedish universities, via direct e-mail and advertisements on Facebook and student union web sites. Those who provide informed consent, have a mobile phone, and show at least hazardous alcohol consumption according to the AUDIT (≥6 for women; ≥8 points for men) are randomized into three groups. Group 1 has access to the Swedish government alcohol monopoly’s app, Promillekoll, offering real-time estimated eBAC calculation; Group 2 has access to a Web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants are controls. Follow-up is conducted at 6, 12 and 18 weeks. Study 2. Participants who at the first 6-week follow-up show drinking levels higher than 9 (W) or 14 (M) standard drinks (12 g alcohol) per week, are offered participation in Study 2. Those who consent are randomized to either access to a skills training app, TeleCoach or to a wait-list control group. Results: Latent Markov models for Study 1 and mixed models analyses for Study 2 will be performed. Study 2 data will be analyzed for publication during the spring of 2016; Study 1 data will be analyzed for publication during the fall of 2016. Conclusions: If mobile phone interventions for reducing hazardous alcohol use are found to be effective, the prospects for positively influencing substance use-related health among university students can considerably improve. Trial Registration: ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/NCT02064998 (Archived by WebCite at http://www.webcitation.org/6dy0AlVRP) %M 26693967 %R 10.2196/resprot.4894 %U http://www.researchprotocols.org/2015/4/e139/ %U https://doi.org/10.2196/resprot.4894 %U http://www.ncbi.nlm.nih.gov/pubmed/26693967 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e125 %T Effectiveness of a Mobile Phone App for Adults That Uses Physical Activity as a Tool to Manage Cigarette Craving After Smoking Cessation: A Study Protocol for a Randomized Controlled Trial %A Hassandra,Mary %A Lintunen,Taru %A Kettunen,Tarja %A Vanhala,Mauno %A Toivonen,Hanna-Mari %A Kinnunen,Kimmo %A Heikkinen,Risto %+ Department of Sport Sciences, University of Jyväskylä, PO Box 35, Jyväskylä, 40014, Finland, 358 408053979, maria.m.chasandra@jyu.fi %K behavior change %K mHealth app %K physical activity %K randomized controlled trial %K relapse prevention %K smoking %D 2015 %7 22.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Results from studies on the effects of exercise on smoking-related variables have provided strong evidence that physical activity acutely reduces cigarette cravings. Mobile technology may provide some valuable tools to move from explanatory randomized controlled trials to pragmatic randomized controlled trials by testing the acute effectiveness of exercise on quitters under real-life conditions. An mHealth app was developed to be used as a support tool for quitters to manage their cigarette cravings. Objective: The primary aim of this paper is to present the protocol of a study examining the effectiveness of the Physical over smoking app (Ph.o.S) by comparing the point prevalence abstinence rate of a group of users to a comparator group during a 6-month follow-up period. Methods: After initial Web-based screening, eligible participants are recruited to attend a smoking cessation program for 3 weeks to set a quit smoking date. Fifty participants who succeed in quitting will be randomly allocated to the comparator and experimental groups. Both groups will separately have 1 more counseling session on how to manage cravings. In this fourth session, the only difference in treatment between the groups is that the experimental group will have an extra 10-15 minutes of guidance on how to use the fully automated Ph.o.S app to manage cravings during the follow-up period. Data will be collected at baseline, as well as before and after the quit day, and follow-up Web-based measures will be collected for a period of 6 months. The primary efficacy outcome is the 7-day point prevalence abstinence rate, and secondary efficacy outcomes are number of relapses and cravings, self-efficacy of being aware of craving experience, self-efficacy in managing cravings, and power of control in managing cravings. Results: Recruitment for this project commenced in December 2014, and proceeded until May 2015. Follow-up data collection has commenced and will be completed by the end of December 2015. Conclusions: If the Ph.o.S app is shown to be effective, the study will provide evidence for the use of the app as a support tool for people who are trying to manage cravings during smoking cessation programs. It is anticipated that the results of the study will provide knowledge of how physical activity affects cigarette craving in real-life situations and inform the development and delivery of relapse prevention in smoking cessation treatment. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN55259451; http://www.controlled-trials.com/ISRCTN55259451 (Archived by WebCite at http://www.webcitation.org/6cKF2mzEI) %M 26494256 %R 10.2196/resprot.4600 %U http://www.researchprotocols.org/2015/4/e125/ %U https://doi.org/10.2196/resprot.4600 %U http://www.ncbi.nlm.nih.gov/pubmed/26494256 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e118 %T Games and Telerehabilitation for Balance Impairments and Gaze Dysfunction: Protocol of a Randomized Controlled Trial %A Szturm,Tony %A Hochman,Jordan %A Wu,Christine %A Lisa,Lix %A Reimer,Karen %A Wonneck,Beth %A Giacobbo,Andrea %+ College of Rehabilitation Sciences, Department of Physical Therapy, University of Manitoba, R106, 771 McDermot Avenue,, Winnipeg, MB, R3E 0T6, Canada, 1 (204) 789 3897, tony.szturm@umanitoba.ca %K balance-exercises %K gaze-exercises %K home therapy %K telerehabilitation %K therapeutic-gaming %K vestibular rehabilitation %D 2015 %7 21.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Digital media and gaming have received considerable interest from researchers and clinicians as a model for learning a broad range of complex tasks and facilitating the transfer of skills to daily life. These emerging rehabilitation technologies have the potential to improve clinical outcomes and patient participation because they are engaging, motivating, and accessible. Our research goal is to develop preventative and therapeutic point-of-care eHealth applications that will lead to equivalent or better long-term health outcomes and health care costs than existing programs. We have produced a novel computer-aided tele-rehabilitation platform that combines computer game-based exercises with tele-monitoring. Objective: Compare the therapeutic effectiveness of an in-home, game-based rehabilitation program (GRP) to standard care delivered in an outpatient physical therapy clinic on measures of balance, gaze control, dizziness, and health-related quality of life. Methods: A randomized, controlled, single-blind pilot trial will be conducted. Fifty-six participants with a diagnosis of peripheral vestibular disorder will be randomly assigned to either usual physical therapy (comparator group) or to a game-based intervention (experimental group). Measures to be assessed will include gaze control, dynamic balance, and self-reported measures of dizziness. Results: The project was funded and enrollment was started in August 2014. To date, 36 participants have been enrolled. There have been 6 drop-outs. It is expected that the study will be completed January 2016 and the first results are expected to be submitted for publication in Spring of 2016. Conclusions: A successful application of this rehabilitation program would help streamline rehabilitation services, leverage therapist time spent with clients, and permit regular practice times at the client’s convenience. Trial Registration: Clinicaltrials.gov: NCT02134444; https://clinicaltrials.gov/ct2/show/NCT02134444 (Archived by WebCite at http://www.webcitation.org/6cE18bqqY) %M 26490109 %R 10.2196/resprot.4743 %U http://www.researchprotocols.org/2015/4/e118/ %U https://doi.org/10.2196/resprot.4743 %U http://www.ncbi.nlm.nih.gov/pubmed/26490109 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e112 %T Guided Internet-Based Parent Training for Challenging Behavior in Children With Fetal Alcohol Spectrum Disorder (Strongest Families FASD): Study Protocol for a Randomized Controlled Trial %A Turner,Karen %A Reynolds,James N %A McGrath,Patrick %A Lingley-Pottie,Patricia %A Huguet,Anna %A Hewitt,Amy %A Green,Courtney %A Wozney,Lori %A Mushquash,Christopher %A Muhajarine,Nazeem %A Sourander,Andre %A Caughey,Heather %A Roane,Jessica %+ IWK Health Centre, 5850/5980 University Avenue, Halifax, NS, B3K 6R8, Canada, 1 902 470 7552, karen.turner@iwk.nshealth.ca %K fetal alcohol spectrum disorder %K neurobehavioral disorder %K prenatal alcohol exposure %K disruptive behavior %K children %K Strongest Families %K parenting %K randomized controlled trial %K eHealth %K Web-based intervention %D 2015 %7 13.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Fetal alcohol spectrum disorder (FASD) is a term used to encompass the full range of neurobehavioral and cognitive dysfunction that may occur as a consequence of prenatal alcohol exposure. There is relatively little research on intervention strategies that specifically target the behavioral problems of children with FASD. Availability and access to services are barriers to timely and effective care for families. The Strongest Families FASD intervention was recently adapted from the Strongest Families “Parenting the Active Child” program to include FASD-specific content delivered via an Internet-based application in conjunction with 11 telephone coaching sessions. Objective: Our objectives are to (1) evaluate the effectiveness of Strongest Families FASD in reducing externalizing problems (primary outcome), internalizing problems, and parent distress (secondary outcomes) in children aged between 4 and 12 years diagnosed with FASD when compared to a control group with access to a static resource Web page; (2) evaluate the effectiveness of Strongest Families FASD in improving social competence (secondary outcome) in school-aged children aged between 6 and 12 diagnosed with FASD when compared with an online psychoeducation control; and (3) explore parental satisfaction with the Strongest Families FASD online parenting program. Methods: Parents and caregivers (N=200) of children diagnosed with FASD who have significant behavioral challenges, ages 4-12, are being recruited into a 2-arm randomized trial. The trial is designed to evaluate the effectiveness of the Web-based Strongest Families FASD parenting intervention on child behavior and caregiver distress, compared to a control group receiving access to a static resource Web page (ie, a list of FASD-specific websites, readings, videos, and organizations). Results: The primary outcome will be externalizing problems measured by the Child Behavior Checklist (CBCL). Secondary outcomes include (1) internalizing problems and (2) social competence, both measured by the CBCL; and (3) parental distress measured by the Depression Anxiety Stress Scale-21. The Client Satisfaction Questionnaire-8 (CSQ-8) and the Satisfaction Survey are completed by the intervention group at the end of session 11. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials (CONSORT) Statement. Conclusions: It is hypothesized that the Strongest Families FASD intervention group will improve child behavior and parental distress. Caregiver satisfaction is anticipated to be positive. Advancing evidence on the effectiveness and acceptance of distance services can inform policy and adoption of eHealth programs. ClinicalTrial: ClinicalTrials.gov NCT02210455; https://clinicaltrials.gov/ct2/show/NCT02210455 (Archived by WebCite at http://www.webcitation.org/6bbW5BSsT) %M 26462968 %R 10.2196/resprot.4723 %U http://www.researchprotocols.org/2015/4/e112/ %U https://doi.org/10.2196/resprot.4723 %U http://www.ncbi.nlm.nih.gov/pubmed/26462968 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e65 %T The Effect of Mobile App Home Monitoring on Number of In-Person Visits Following Ambulatory Surgery: Protocol for a Randomized Controlled Trial %A Armstrong,Kathleen A %A Coyte,Peter C %A Bhatia,R Sacha %A Semple,John L %+ Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Toronto, 149 College Street, 5th Floor, Room 508, Toronto, ON, M5T 1P5, Canada, 1 416 978 8534, k.armstrong@mail.utoronto.ca %K mobile apps %K randomized controlled trial, cost-effectiveness %K ambulatory surgical procedures %K ambulatory monitoring %K technology assessment %D 2015 %7 03.06.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Women’s College Hospital, Toronto, Canada, offers specialized ambulatory surgical procedures. Patients often travel great distances to undergo surgery. Most patients receiving ambulatory surgery have a low rate of postoperative events necessitating clinic visits. However, regular follow-up is still considered important in the early postoperative phase. Increasingly, telemedicine is used to overcome the distance patients must travel to receive specialized care. Telemedicine data suggest that mobile monitoring and follow-up care is valued by patients and can reduce costs to society. Women’s College Hospital has used a mobile app (QoC Health Inc) to complement in-person postoperative follow-up care for breast reconstruction patients. Preliminary studies suggest that mobile app follow-up care is feasible, can avert in-person follow-up care, and is cost-effective from a societal and health care system perspective. Objective: We hope to expand the use of mobile app follow-up care through its formal assessment in a randomized controlled trial. In postoperative ambulatory surgery patients at Women’s College Hospital (WCH), can we avert in-person follow-up care through the use of mobile app follow-up care compared to conventional, in-person follow-up care in the first 30 days after surgery. Methods: This will be a pragmatic, single-center, open, controlled, 2-arm parallel-group superiority randomized trial comparing mobile app and in-person follow-up care over the first month following surgery. The patient population will comprise all postoperative ambulatory surgery patients at WCH undergoing breast reconstruction. The intervention consists of a postoperative mobile app follow-up care using the quality of recovery-9 (QoR9) and a pain visual analog scale (VAS), surgery-specific questions, and surgical site photos submitted daily for the first 2 weeks and weekly for the following 2 weeks. The primary outcome is the total number of physician visits related to the surgery over the first 30-days postoperative. The secondary outcomes include (1) the total number of phone calls and emails to a health care professional related to surgery, (2) complication rate, (3) societal and health care system costs, and (4) patient satisfaction over the first 30 days postoperative. Permutated-block randomization will be conducted by blocks of 4-6 using the program ralloc in Stata. This is an open study due to the nature of the intervention. Results: A sample of 72 (36 patients per group) will provide an E-test for count data with a power of 95% (P=.05) to detect a difference of 1 visit between groups, assuming a 10% drop out rate. Count variables will be analyzed using Poisson regression. Categorical variables will be tested using a chi-square test. Cost-effectiveness will be analyzed using net benefit regression. Outcomes will be assessed over the first 30 days following surgery. Conclusions: We hope to show that the use of a mobile app in follow-up care minimizes the need for in-person visits for postoperative patients. Trial Registration: Clinicaltrials.gov NCT02318953; https://clinicaltrials.gov/ct2/show/NCT02318953 (Archived by WebCite at http://www.webcitation.org/6Yifzdjph). %M 26040252 %R 10.2196/resprot.4352 %U http://www.researchprotocols.org/2015/2/e65/ %U https://doi.org/10.2196/resprot.4352 %U http://www.ncbi.nlm.nih.gov/pubmed/26040252 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e55 %T Supportive Text Messages to Reduce Mood Symptoms and Problem Drinking in Patients With Primary Depression or Alcohol Use Disorder: Protocol for an Implementation Research Study %A Agyapong,Vincent Israel Opoku %A Mrklas,Kelly %A Suen,Victoria Yung Mei %A Rose,Marianne Sarah %A Jahn,Megan %A Gladue,Irene %A Kozak,Jody %A Leslie,Maureen %A Dursun,Serdar %A Ohinmaa,Arto %A Greenshaw,Andrew %+ Faculty of Health Sciences, Department of Psychiatry, University of Alberta, 1E1 Walter Mackenzie Health Sciences Centre (WMC), 8440 112 St NW, Edmonton, AB, T6G 2B7, Canada, 1 780 215 7771, agyapong@ualberta.ca %K depression %K alcohol use disorder %K supportive text messages %K intervention %D 2015 %7 15.05.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Depression and Alcohol Use Disorders (AUDs) are two leading causes of disability worldwide and are associated with significant treatment challenges requiring new, innovative, cost-effective and technologically-based therapies including the use of supportive text messages. Objective: To determine the feasibility and effectiveness of supportive text messages in long-term follow-up to reduce mood symptoms and problem drinking in patients with Depression or AUD respectively and to explore the usefulness of self-reports of health services utilization as an outcomes measure. Methods: This will be a longitudinal, prospective, parallel-design, two-arm, placebo-controlled single-rater-blinded randomized clinical trial with a recruitment period of 6 months and an observation period of 12 months for each participant, with two strata based on primary diagnosis of Major Depressive Disorder or AUD. The sample size will be 120, with about 60 patients randomized from each primary diagnostic grouping. Patients in all intervention groups will receive twice-daily supportive SMS text messages for 3 months and then daily supportive text messages for the next three months. Patients will also receive a phone call every two weeks from the research assistant assigning treatment allocation to confirm that they are still receiving the text messages and to thank them for taking part in the study. Patients in the control group will receive no text messages but will also receive a phone call from the same research assistant every two weeks to thank them for taking part in the study. Results: The study starts in April 2015 and ends in September 2016. It is envisaged that both qualitative and quantitative primary and secondary outcomes, including patient perceptions of the intervention, will shed light on the feasibility of using automated supportive text message interventions in long term for patients with Depression and AUD. This will inform a full-scale clinical trial. Conclusions: The paradigm for behavior change using text messages as a patient-direct intervention is consistent with a cognitive behavior therapy approach and addictions counselling principles. Given the automaticity of the messages, we anticipate that if the intervention proves successful, it will represent a low cost strategy that will be readily available and can bring relief to patients in hard-to-reach areas with limited access to psychological therapies. Trial Registration: ClinicalTrials.gov: NCT02327858; https://clinicaltrials.gov/ct2/show/NCT02327858 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02327858). %M 25979786 %R 10.2196/resprot.4371 %U http://www.researchprotocols.org/2015/2/e55/ %U https://doi.org/10.2196/resprot.4371 %U http://www.ncbi.nlm.nih.gov/pubmed/25979786 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e48 %T Development of an Online Well-Being Intervention for Young People: An Evaluation Protocol %A Antezana,Gaston %A Bidargaddi,Niranjan %A Blake,Victoria %A Schrader,Geoffrey %A Kaambwa,Billingsley %A Quinn,Stephen %A Orlowski,Simone %A Winsall,Megan %A Battersby,Malcolm %+ Flinders Human Behaviour & Health Research Unit (FHBHRU), Department of Psychiatry, School of Medicine, Flinders University, Room 4T303, Margaret Tobin Centre - FMC, Sturt Road, Bedford Park, South Australia, Adelaide, 5042, Australia, 61 (8) 84042 613, gaston.antezana@flinders.edu.au %K well-being %K mental health %K young people %K online intervention %K apps %K engagement %D 2015 %7 30.04.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Research has shown that improving well-being using positive mental health interventions can be useful for predicting and preventing mental illness. Implementing online interventions may be an effective way to reach young people, given their familiarity with technology. Objective: This study will assess the effectiveness of a website called the “Online Wellbeing Centre (OWC),” designed for the support and improvement of mental health and well-being in young Australians aged between 16 and 25 years. As the active component of the study, the OWC will introduce a self-guided app recommendation service called “The Toolbox: The best apps for your brain and body” developed by ReachOut.com. The Toolbox is a responsive website that serves as a personalized, ongoing recommendation service for technology-based tools and apps to improve well-being. It allows users to personalize their experience according to their individual needs. Methods: This study will be a two-arm, randomized controlled trial following a wait-list control design. The primary outcome will be changes in psychological well-being measured by the Mental Health Continuum Short Form. The secondary outcomes will be drawn from a subsample of participants and will include depression scores measured by the Center for Epidemiologic Studies Depression Scale, and quality of life measured by the Assessment of Quality of Life-four dimensions (AQOL-4D) index. Cost-effectiveness analysis will be conducted based on a primary outcome of cost per unique visit to the OWC. Utility-based outcomes will also be incorporated into the analysis allowing a secondary outcome to be cost per quality-adjusted life year gained (based on the AQOL-4D values). Resource use associated with both the intervention and control groups will be collected using a customized questionnaire. Online- and community-based recruitment strategies will be implemented, and the effectiveness of each approach will be analyzed. Participants will be recruited from the general Australian population and randomized online. The trial will last for 4 weeks. Results: Small but clinically significant increases in well-being symptoms are expected to be detected in the intervention group compared with the control group. Conclusions: If this intervention proves to be effective, it will have an impact on the future design and implementation of online-based well-being interventions as a valid and cost-effective way to support mental health clinical treatment. Findings regarding recruitment effectiveness will also contribute to developing better ways to engage this population in research. ClinicalTrial: This study is registered in the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000710628. %M 25929201 %R 10.2196/resprot.4098 %U http://www.researchprotocols.org/2015/2/e48/ %U https://doi.org/10.2196/resprot.4098 %U http://www.ncbi.nlm.nih.gov/pubmed/25929201 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e35 %T Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study %A Avis,Jillian LS %A Cave,Andrew L %A Donaldson,Stephanie %A Ellendt,Carol %A Holt,Nicholas L %A Jelinski,Susan %A Martz,Patricia %A Maximova,Katerina %A Padwal,Raj %A Wild,T Cameron %A Ball,Geoff DC %+ Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, 11405 - 87 Avenue NW, Edmonton, AB, T6G1C9, Canada, 1 780 492 8727, gdball@ualberta.ca %K body weight %K Canada %K child %K childhood obesity %K Internet %K parents %K prevention %K primary health care %D 2015 %7 25.03.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Parents play a central role in preventing childhood obesity. There is a need for innovative, scalable, and evidence-based interventions designed to enhance parents’ motivation to support and sustain healthy lifestyle behaviors in their children, which can facilitate obesity prevention. Objective: (1) Develop an online screening, brief intervention, and referral to treatment (SBIRT) eHealth tool to enhance parents’ concern for, and motivation to, support children’s healthy lifestyle behaviors, (2) refine the SBIRT eHealth tool by assessing end-user acceptability, satisfaction, and usability through focus groups, and (3) determine feasibility and preliminary effectiveness of the refined SBIRT eHealth tool through a randomized controlled trial. Methods: This is a three-phase, multi-method study that includes SBIRT eHealth tool development (Phase I), refinement (Phase II), and testing (Phase III). Phase I: Theoretical underpinnings of the SBIRT tool, entitled the Resource Information Program for Parents on Lifestyle and Education (RIPPLE), will be informed by concepts applied within existing interventions, and content will be based on literature regarding healthy lifestyle behaviors in children. The SBIRT platform will be developed in partnership between our research team and a third-party intervention development company. Phase II: Focus groups with parents, as well as health care professionals, researchers, and trainees in pediatrics (n=30), will explore intervention-related perceptions and preferences. Qualitative data from the focus groups will inform refinements to the aesthetics, content, structure, and function of the SBIRT. Phase III: Parents (n=200) of children—boys and girls, 5 to 17 years old—will be recruited from a primary care pediatric clinic while they await their children’s clinical appointment. Parents will be randomly assigned to one of five groups—four intervention groups and one control group—as they complete the SBIRT. The randomization function is built into the tool. Parents will complete the eHealth SBIRT using a tablet that will be connected to the Internet. Subsequently, parents will be contacted via email at 1-month follow-up to assess (1) change in concern for, and motivation to, support children’s dietary and physical activity behaviors (primary outcome), and (2) use of online resources and referrals to health services for obesity prevention (secondary outcome). Results: This research was successfully funded and received ethics approval. Development of the SBIRT started in summer 2012, and we expect all study-related activities to be completed by fall 2016. Conclusions: The proposed research is timely and applies a novel, technology-based application designed to enhance parents concern for, and motivation to, support children’s healthy lifestyle behaviors and encourage use of online resources and community services for childhood obesity prevention. Overall, this research builds on a foundation of evidence supporting the application of SBIRTs to encourage or “nudge” individuals to make healthy lifestyle choices. Findings from Phase III of this project will directly inform a cluster randomized controlled trial to study the effectiveness of our intervention across multiple primary care-based settings. Trial Registration: ClinicalTrials.gov NCT02330588; http://clinicaltrials.gov/ct2/show/NCT02330588 (Archived by WebCite at http://www.webcitation.org/6WyUOeRlr). %M 25831265 %R 10.2196/resprot.4147 %U http://www.researchprotocols.org/2015/1/e35/ %U https://doi.org/10.2196/resprot.4147 %U http://www.ncbi.nlm.nih.gov/pubmed/25831265 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e23 %T Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial %A Atreja,Ashish %A Khan,Sameer %A Rogers,Jason D %A Otobo,Emamuzo %A Patel,Nishant P %A Ullman,Thomas %A Colombel,Jean Fred %A Moore,Shirley %A Sands,Bruce E %A , %+ Sinai AppLab, Division of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai, Mailbox 1469, 1468 Madison Avenue, New York, NY, 10029, United States, 1 212 241 5090, ashish.atreja@mssm.edu %K medical informatics %K patient reported outcome %K mHealth %K engagement %D 2015 %7 18.02.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Inflammatory bowel disease (IBD) is a chronic condition of the bowel that affects over 1 million people in the United States. The recurring nature of disease makes IBD patients ideal candidates for patient-engaged care that is centered on enhanced self-management and improved doctor-patient communication. In IBD, optimal approaches to management vary for patients with different phenotypes and extent of disease and past surgical history. Hence, a single quality metric cannot define a heterogeneous disease such as IBD, unlike hypertension and diabetes. A more comprehensive assessment may be provided by complementing traditional quality metrics with measures of the patient’s quality of life (QOL) through an application like HealthPROMISE. Objective: The objective of this pragmatic randomized controlled trial is to determine the impact of the HealthPROMISE app in improving outcomes (quality of care [QOC], QOL, patient adherence, disease control, and resource utilization) as compared to a patient education app. Our hypothesis is that a patient-centric self-monitoring and collaborative decision support platform will lead to sustainable improvement in overall QOL for IBD patients. Methods: Participants will be recruited during face-to-face visits and randomized to either an interventional (ie, HealthPROMISE) or control (ie, education app). Patients in the HealthPROMISE arm will be able to update their information and receive disease summary, quality metrics, and a graph showing the trend of QOL (SIBDQ) scores and resource utilization over time. Providers will use the data for collaborative decision making and quality improvement interventions at the point of care. Patients in the control arm will enter data at baseline, during office visits, and at the end of the study but will not receive any decision support (trend of QOL, alert, or dashboard views). Results: Enrollment in the trial will be starting in first quarter of 2015. It is intended that up to 300 patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints. Conclusions: HealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not. Trial Registration: ClinicalTrials.gov NCT02322307; https://clinicaltrials.gov/ct2/show/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr). %M 25693610 %R 10.2196/resprot.4042 %U http://www.researchprotocols.org/2015/1/e23/ %U https://doi.org/10.2196/resprot.4042 %U http://www.ncbi.nlm.nih.gov/pubmed/25693610 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e19 %T Internet-Based Implementation of Non-Pharmacological Interventions of the "People Getting a Grip on Arthritis" Educational Program: An International Online Knowledge Translation Randomized Controlled Trial Design Protocol %A Brosseau,Lucie %A Wells,George %A Brooks-Lineker,Sydney %A Bennell,Kim %A Sherrington,Cathie %A Briggs,Andrew %A Sturnieks,Daina %A King,Judy %A Thomas,Roanne %A Egan,Mary %A Loew,Laurianne %A De Angelis,Gino %A Casimiro,Lynn %A Toupin April,Karine %A Cavallo,Sabrina %A Bell,Mary %A Ahmed,Rukhsana %A Coyle,Doug %A Poitras,Stéphane %A Smith,Christine %A Pugh,Arlanna %A Rahman,Prinon %+ School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Roger Guindon Hall, 451 Smyth Road, Ottawa, ON, K1H 8M5, Canada, 1 613 562 5800 ext 8015, Lucie.Brosseau@uottawa.ca %K rheumatoid arthritis %K technology %K knowledge translation %K clinical trial %K social media %D 2015 %7 03.02.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Rheumatoid arthritis (RA) affects 2.1% of the Australian population (1.5% males; 2.6% females), with the highest prevalence from ages 55 to over 75 years (4.4-6.1%). In Canada, RA affects approximately 0.9% of adults, and within 30 years that is expected to increase to 1.3%. With an aging population and a greater number of individuals with modifiable risk factors for chronic diseases, such as arthritis, there is an urgent need for co-care management of arthritic conditions. The increasing trend and present shifts in the health services and policy sectors suggest that digital information delivery is becoming more prominent. Therefore, it is necessary to further investigate the use of online resources for RA information delivery. Objective: The objective is to examine the effect of implementing an online program provided to patients with RA, the People Getting a Grip on Arthritis for RA (PGrip-RA) program, using information communication technologies (ie, Facebook and emails) in combination with arthritis health care professional support and electronic educational pamphlets. We believe this can serve as a useful and economical method of knowledge translation (KT). Methods: This KT randomized controlled trial will use a prospective randomized open-label blinded-endpoint design to compare four different intervention approaches of the PGrip-RA program to a control group receiving general electronic educational pamphlets self-management in RA via email. Depending on group allocation, links to the Arthritis Society PGrip-RA material will be provided either through Facebook or by email. One group will receive feedback online from trained health care professionals. The intervention period is 6 weeks. Participants will have access to the Internet-based material after the completion of the baseline questionnaires until the final follow-up questionnaire at 6 months. We will invite 396 patients from Canadian and Australian Arthritis Consumers’ Associations to participate using online recruitment. Results: This study will build on a pilot study using Facebook, which revealed promising effects of knowledge acquisition/integration of the evidence-based self-management PGrip educational program. Conclusions: The use of online techniques to disseminate knowledge provides an opportunity to reduce health care costs by facilitating self-management of people with arthritis. Study design strengths include the incorporation of randomization and allocation concealment to ensure internal validity. To avoid intergroup contamination, the Facebook group page security settings will be set to “closed”, thus allowing only invited participants to access it. Study limitations include the lack of participant blinding due to the characteristics of this KT randomized controlled trial and a potential bias of recruiting patients only online, though this was proven effective in the previous pilot study. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12614000397617; http://www.anzctr.org.au/TrialSearch.aspx (Archived by WebCite at http://www.webcitation.org/6PrP0kQf8). %M 25648515 %R 10.2196/resprot.3572 %U http://www.researchprotocols.org/2015/1/e19/ %U https://doi.org/10.2196/resprot.3572 %U http://www.ncbi.nlm.nih.gov/pubmed/25648515 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e3 %T A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol %A Block,Gladys %A Azar,Kristen MJ %A Block,Torin J %A Romanelli,Robert J %A Carpenter,Heather %A Hopkins,Donald %A Palaniappan,Latha %A Block,Clifford H %+ NutritionQuest, Inc., 15 Shattuck Square, Suite 288, Berkeley, CA, 94704, United States, 1 510 704 8514, gblock@berkeley.edu %K prediabetes %K insulin resistance %K diabetes %K prevention %K obesity %K physical activity %K internet %K world wide web %K blood glucose %K metabolic syndrome %D 2015 %7 21.01.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective: Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods: Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results: A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions: The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. Trial Registration: ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo). %M 25608692 %R 10.2196/resprot.4046 %U http://www.researchprotocols.org/2015/1/e3/ %U https://doi.org/10.2196/resprot.4046 %U http://www.ncbi.nlm.nih.gov/pubmed/25608692 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e1 %T Text Messaging to Improve Hypertension Medication Adherence in African Americans: BPMED Intervention Development and Study Protocol %A Buis,Lorraine R %A Artinian,Nancy T %A Schwiebert,Loren %A Yarandi,Hossein %A Levy,Phillip D %+ University of Michigan, Department of Family Medicine, 1018 Fuller St., Ann Arbor, MI, 48104, United States, 1 734 998 7120, buisl@umich.edu %K mobile phone %K text messaging %K hypertension %K blood pressure %K African Americans %K medication adherence %K mobile health %D 2015 %7 02.01.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension (HTN) is a major public health concern in the United States, with almost 78 million Americans age 20 years and over suffering from the condition. Moreover, HTN is a key risk factor for health disease and stroke. African Americans disproportionately shoulder the burdens of HTN, with greater prevalence, disease severity, earlier onset, and more HTN-related complications than age-matched whites. Medication adherence for the treatment of HTN is poor, with estimates indicating that only about half of hypertensive patients are adherent to prescribed medication regimens. Although no single intervention for improving medication adherence has emerged as superior to others, text message medication reminders have the potential to help improve medication adherence in African Americans with uncontrolled HTN as mobile phone adoption is very high in this population. Objective: The purpose of this two-phased study was to develop (Phase I) and test in a randomized controlled trial (RCT) (Phase II) a text message system, BPMED, to improve the quality of medication management through increasing medication adherence in African Americans with uncontrolled HTN. Methods: In Phase I, we recruited 16 target end-users from a primary care clinic, to assist in the development of BPMED through participating in one of three focus groups. Focus groups sought to gain patient perspectives on HTN, medication adherence, mobile phone use, and the use of text messaging to support medication adherence. Potential intervention designs were presented to participants, and feedback on the designs was solicited. In Phase II, we conducted two pilot RCTs to determine the feasibility, acceptability, and preliminary efficacy of BPMED in primary care and emergency department settings. Both pilot studies recruited approximately 60 participants, who were randomized equally between usual care and the BPMED intervention. Results: Although data collection is now complete, data analysis from the two pilot RCTs is still ongoing and results are expected in 2015. Conclusions: This study was designed to determine preliminary feasibility and acceptability of our approach among African Americans with uncontrolled HTN in primary care and emergency department settings. Results from these studies are of great interest as little work has been done to document the use of text message medication reminders to improve HTN-related outcomes, particularly within underserved urban minorities. Trial Registration: Clinicaltrials.gov NCT01465217; https://clinicaltrials.gov/ct2/show/NCT01465217 (Archived by WebCite at http://www.webcitation.org/6V0tto0lZ). %M 25565680 %R 10.2196/resprot.4040 %U http://www.researchprotocols.org/2015/1/e1/ %U https://doi.org/10.2196/resprot.4040 %U http://www.ncbi.nlm.nih.gov/pubmed/25565680 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e79 %T Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Novel Mobile Phone-Based Intervention: Study Design of a Randomized Controlled Trial %A Agboola,Stephen %A Flanagan,Clare %A Searl,Meghan %A Elfiky,Aymen %A Kvedar,Joseph %A Jethwani,Kamal %+ Partners Healthcare Center for Connected Health, 25 New Chardon St., Suite 300, Boston, MA, 02114, United States, 1 617 643 0291, sagboola@partners.org %K cancer %K oral anti-cancer medication %K mobile application %K randomized controlled trial %K self-care %K mHealth %K medication adherence %D 2014 %7 23.12.2014 %9 Protocol %J JMIR Res Protoc %G English %X Background: The widespread and increasing use of oral anti-cancer medications has been ushered in by a rapidly increasing understanding of cancer pathophysiology. Furthermore, their popular ease of administration and potential cost savings has highlighted their central position in the health care system as a whole. These facts have heightened appreciation of the unique challenges associated with the use of oral anti-cancer medications; especially in the long-term use of these medications and the associated side effects that may impede optimal adherence to their use. Therefore, we developed ChemOtheRapy Assistant, CORA, a personalized mobile phone–based self-management application to help cancer patients on oral anti-cancer medications. Objective: Our objective is to evaluate the effect of CORA on adherence to oral anti-cancer medications and other clinically relevant outcomes in the management of patients with renal and prostate cancer. Methods: The study will be implemented as a 2-parallel group randomized controlled trial in 104 patients with renal or prostate cancer on oral anti-cancer medications over a 3-month study period. The intervention group will use CORA in addition to usual care for self-management while the control group will continue care as usual. Medication adherence will be measured objectively by a Medication Event Monitoring System device and is defined as the percentage of prescribed doses taken. We will also assess the effect of the intervention on cancer-related symptoms measured by the MD Anderson Symptom Inventory and unplanned hospital utilizations. Other outcomes that will be measured at study start, midpoint, and endpoint are health-related quality of life, cancer-related fatigue, and anxiety. Group differences in medication adherence will be examined by t tests or by non-parametric Mann-Whitney tests if the data are not normally distributed. Logistic regression will be used to identify potential predictors of adherence. Results: We expect to have results for this study before the end of 2016. Conclusions: This novel mobile phone–enabled, multimodal self-management and educational intervention could lead to improvements in clinical outcomes and serve as a foundation for future mHealth research in improving outcomes for patients on oral anti-cancer medications. %M 25537463 %R 10.2196/resprot.4041 %U http://www.researchprotocols.org/2014/4/e79/ %U https://doi.org/10.2196/resprot.4041 %U http://www.ncbi.nlm.nih.gov/pubmed/25537463 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e80 %T A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial %A Imam,Bita %A Miller,William C %A Finlayson,Heather C %A Eng,Janice J %A Payne,Michael WC %A Jarus,Tal %A Goldsmith,Charles H %A Mitchell,Ian M %+ Department of Occupational Science and Occupational Therapy, University of British Columbia, Koerner Pavilion, Room T314, 2211 Wesbrook Mall, Vancouver, BC, V6T 2B3, Canada, 1 604 714 4108, bill.miller@ubc.ca %K amputation %K adult %K aged %K randomized controlled trial %K telemedicine %K walking %D 2014 %7 22.12.2014 %9 Protocol %J JMIR Res Protoc %G English %X Background: The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed “Wii.n.Walk”, an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA. Objective: The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group. Methods: This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants’ homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks’ duration. The primary outcome measure will be the “Two-Minute Walk Test” to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up. Results: Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. Conclusions: Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. Trial Registration: Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP). %M 25533902 %R 10.2196/resprot.4031 %U http://www.researchprotocols.org/2014/4/e80/ %U https://doi.org/10.2196/resprot.4031 %U http://www.ncbi.nlm.nih.gov/pubmed/25533902 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e76 %T Pain Management in Cancer Patients Using a Mobile App: Study Design of a Randomized Controlled Trial %A Agboola,Stephen %A Kamdar,Mihir %A Flanagan,Clare %A Searl,Meghan %A Traeger,Lara %A Kvedar,Joseph %A Jethwani,Kamal %+ Center for Connected Health, 25 New Chardon st, Suite 300, Boston, MA, 02114, United States, 1 617 643 0291, sagboola@partners.org %K cancer pain %K mobile application %K randomized controlled trial %K self care %K palliative care %K mHealth %D 2014 %7 12.12.2014 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite the availability of effective medications and clinical guidelines for pain management, pain control is suboptimal in a sizeable proportion of patients with cancer pain. The National Comprehensive Cancer Network guidelines recommend a comprehensive and multimodal approach for management of cancer pain. We developed a mobile phone application, ePAL, based on clinical guidelines to empower patients for cancer pain management by prompting regular pain assessments and coaching for self-management. Objective: The objective of this study is to evaluate the effect of a multidimensional mobile phone-based pain management application, ePAL, on controlling cancer pain and improving quality of life in patients with cancer pain being treated at an academic palliative care clinic. Methods: The study will be implemented as a 2-arm randomized controlled trial with 110 adult patients with CP who own a mobile phone over a follow-up period of two months. Participants will be randomized to either the intervention group receiving ePAL and usual care or to a control group receiving only usual care. The brief pain inventory will be used to assess our primary outcome which is pain intensity. We will also evaluate the effect of the intervention on secondary outcomes which include the effect of the intervention on hospital utilization for pain crisis, quality of life, adherence to analgesic medications, barriers to pain control, anxiety and patient engagement. Instruments that will be used in evaluating secondary outcomes include the Brief Pain Inventory, Morisky Medication Adherence Scale, Barriers Questionnaire-II, Functional Assessment of Cancer Therapy–General, Edmonton Symptom Assessment System, Generalized Anxiety Disorder 7-item scale, and the Functional Assessment of Chronic Illness Therapy-Fatigue. The intention-to-treat approach will be used to evaluate outcomes. Our primary outcome, pain intensity, measured longitudinally over eight weeks, will be assessed by mixed model repeated analysis. Effect sizes will be calculated as mean group differences with standard deviations. Results: The study is still in progress. We hope to have results by the end of 2015. Conclusions: The multidimensional approach to pain management implemented on a mobile phone application could lead to significant improvements in patient outcomes. Trial Registration: ClinicalTrials.gov NCT02069743; https://clinicaltrials.gov/ct2/show/NCT02069743 (Archived by WebCite at http://www.webcitation.org/6Qb65XGGA). %M 25500281 %R 10.2196/resprot.3957 %U http://www.researchprotocols.org/2014/4/e76/ %U https://doi.org/10.2196/resprot.3957 %U http://www.ncbi.nlm.nih.gov/pubmed/25500281 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e62 %T Comparison of Two Theory-Based, Fully Automated Telephone Interventions Designed to Maintain Dietary Change in Healthy Adults: Study Protocol of a Three-Arm Randomized Controlled Trial %A Wright,Julie A %A Quintiliani,Lisa M %A Turner-McGrievy,Gabrielle M %A Migneault,Jeffrey P %A Heeren,Timothy %A Friedman,Robert H %+ Department of Exercise and Health Sciences, University of Massachusetts Boston, 100 Morrissey Blvd, Boston, MA, 02125, United States, 1 617 287 3808, julie.wright@umb.edu %K maintenance %K social cognitive theory %K goals %K fruit %K vegetable %K diet %K telephone %K health information systems %D 2014 %7 10.11.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. Objective: The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. Methods: The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405 participants who qualify for the trial will complete surveys administered by blinded interviewers at baseline (randomization), 6, 12, 18, and 24 months. Results: Data analysis is not yet complete, but we hypothesize that (1) TLC-GST > TLC-SCT > control at all follow-up time points for F&V consumption, and (2) intervention effects will be mediated by the theoretical constructs (eg, self-efficacy, goal pursuit, conflict, shielding, and facilitation). Conclusions: This study used a novel study design to initiate and then promote the maintenance of dietary behavior change through the use of an evidence-based fully automated telephony intervention. After the first 6 months (the acquisition phase), we will examine whether two telephony interventions built using different underlying behavioral theories were more successful than an assessment-only control group in helping participants maintain their newly acquired health behavior change. Trial Registration: Clinicaltrials.gov NCT00148525; http://clinicaltrials.gov/ct2/show/NCT00148525 (Archived by Webcite at http://www.webcitation.org/6TiRriJOs). %M 25387065 %R 10.2196/resprot.3367 %U http://www.researchprotocols.org/2014/4/e62/ %U https://doi.org/10.2196/resprot.3367 %U http://www.ncbi.nlm.nih.gov/pubmed/25387065 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 2 %P e30 %T The Cost Effectiveness of a Tailored, Web-Based Care Program to Enhance Postoperative Recovery in Gynecologic Patients in Comparison With Usual Care: Protocol of a Stepped Wedge Cluster Randomized Controlled Trial %A Bouwsma,Esther VA %A Anema,Johannes R %A Vonk Noordegraaf,Antonie %A Knol,Dirk L %A Bosmans,Judith E %A Schraffordt Koops,Steven E %A van Kesteren,Paul JM %A van Baal,W Marchien %A Lips,Jos P %A Emanuel,Mark H %A Scholten,Petrus C %A Mozes,Alexander %A Adriaanse,Albert H %A Brölmann,Hans AM %A Huirne,Judith AF %+ Department of Obstetrics and Gynecology, VU University Medical Center, De Boelelaan 1117, Amsterdam, , Netherlands, 31 20444 4827, j.huirne@vumc.nl %K gynecology %K Internet %K telemedicine %K convalescence %K return to work %K economic evaluation %D 2014 %7 18.06.2014 %9 Protocol %J JMIR Res Protoc %G English %X Background: The length of recovery after benign gynecological surgery and return to work frequently exceeds the period that is recommended or expected by specialists. A prolonged recovery is associated with a poorer quality of life. In addition, costs due to prolonged sick leave following gynecological surgery cause a significant financial burden on society. Objective: The objective of our study was to present the protocol of a stepped wedge cluster randomized controlled trial to evaluate the cost effectiveness of a new care program for patients undergoing hysterectomy and/or adnexal surgery for benign disease, compared to the usual care. Methods: The care program under study, designed to improve convalescence and to prevent delayed return to work, targets two levels. At the hospital level, guidelines will be distributed among clinical staff in order to stimulate evidence-based patient education. At the patient level, additional perioperative guidance is provided by means of an eHealth intervention, equipping patients with tailored convalescence advice, and an occupational intervention is available for those patients at risk of prolonged sick leave. Due to the stepped wedge design of the trial, the care program will be sequentially rolled out among the 9 participating hospitals, from which the patients are recruited. Eligible for this study are employed women, 18-65 years of age, who are scheduled for hysterectomy and/or laparoscopic adnexal surgery. The primary outcome is full sustainable return to work. The secondary outcomes include general recovery, quality of life, self-efficacy, coping, and pain. The data will be collected by means of self-reported electronic questionnaires before surgery and at 2, 6, 12, 26, and 52 weeks after surgery. Sick leave and cost data are measured by monthly sick leave calendars, and cost diaries during the 12 month follow-up period. The economic evaluation will be performed from the societal perspective. All statistical analyses will be conducted according to the intention-to-treat principle. Results: The enrollment of the patients started October 2011. The follow-up period will be completed in August 2014. Data cleaning or analysis has not begun as of this article’s submission. Conclusions: We hypothesize the care program to be effective by means of improving convalescence and reducing costs associated with productivity losses following gynecological surgery. The results of this study will enable health care policy makers to decide about future implementation of this care program on a broad scale. Trial Registration: Netherlands Trial Register: NTR2933; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2933 (Archived by WebCite at http://www.webcitation.org/6Q7exPG84). %M 24943277 %R 10.2196/resprot.3236 %U http://www.researchprotocols.org/2014/2/e30/ %U https://doi.org/10.2196/resprot.3236 %U http://www.ncbi.nlm.nih.gov/pubmed/24943277 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 2 %N 2 %P e55 %T Evaluating the Efficacy of a Web-Based Program (Diapason) for Informal Caregivers of Patients With Alzheimer’s Disease: Protocol for a Randomized Clinical Trial %A Cristancho-Lacroix,Victoria %A Kerhervé,Hélène %A de Rotrou,Jocelyne %A Rouquette,Alexandra %A Legouverneur,Grégory %A Rigaud,Anne-Sophie %+ Broca Hospital-APHP, Department of Gerontology, 54-56 rue Pascal, Paris, 75013, France, 33 33144083351, victoria.cristancho@gmail.com %K family caregivers %K Alzheimer's disease %K Internet %K program effectiveness %K psychoeducational program %K psychological stress %K randomized clinical trials %D 2013 %7 06.12.2013 %9 Protocol %J JMIR Res Protoc %G English %X Background: Informal caregivers (CGs) of patients with Alzheimer’s disease are at risk of suffering from psychological and physical weakening. Several psychoeducational interventions have been designed to prevent stress and burden of caregivers. In France, despite health authorities’ recommendations, to our knowledge there is no rigorously assessed Web-based psychoeducational program to date. Objective: The objective of our study was to assess the efficacy of a French Web-based psychoeducational program (called Diapason) with an unblinded randomized clinical trial. Methods: In this protocol, 80 informal caregivers of patients followed at Broca Hospital are recruited offline and randomized in the experimental condition (EC) or the control condition (CC). The volunteers in EC have to visit a closed online user group at least once a week and validate one new session of this fully automated Web program, during 12 weeks. Each week a new thematic is added to the website. The participants in the CC receive usual care, and have access to the Diapason program after their participation (6 months). Face-to-face evaluations for both groups are planned every 3 months (M0–M3 and M6). The main objective of this program is to provide CGs with information on the disease process, how to prevent psychological strain (using anticipation and relaxation techniques), and offering a virtual space (forum) to discuss with other caregivers. The primary outcome of this study is the self-perceived stress, while self-efficacy, burden, depression, and self-perceived health status are defined as secondary outcomes. Other variables that might have an impact on the program efficacy are collected. Results: This protocol was accepted for funding. The enrollment began in October 2011, and participants currently recruited will finish their evaluations in January 2014. The results are expected for June 2014. Conclusions: Findings might provide empirical evidence on: (1) the feasibility of an Internet-based program in the French context, (2) the effectiveness of a Web-based program for informal caregivers, and (3) the identification of caregivers who will benefit from this type of intervention. Trial Registration: Clinicaltrials.gov NCT01430286; http://clinicaltrials.gov/ct2/show/NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL). %M 24317497 %R 10.2196/resprot.2978 %U http://www.researchprotocols.org/2013/2/e55/ %U https://doi.org/10.2196/resprot.2978 %U http://www.ncbi.nlm.nih.gov/pubmed/24317497 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 2 %N 1 %P e17 %T Capitalizing on the Teachable Moment: Osteoarthritis Physical Activity and Exercise Net for Improving Physical Activity in Early Knee Osteoarthritis %A Li,Linda C %A Lineker,Sydney %A Cibere,Jolanda %A Crooks,Valorie A %A Jones,Catherine A %A Kopec,Jacek A %A Lear,Scott A %A Pencharz,James %A Rhodes,Ryan E %A Esdaile,John M %+ Arthritis Research Centre of Canada, 5591 No. 3 Road, Richmond, BC, V6X 2C7, Canada, 1 604 207 4020, lli@arthritisresearch.ca %K osteoarthritis physical activity %K Internet %K lifestyle intervention %K theory of planned behavior %D 2013 %7 09.05.2013 %9 Protocol %J JMIR Res Protoc %G English %X Background: Practice guidelines emphasize the use of exercise and weight reduction as the first line of management for knee osteoarthritis (OA). However, less than half of the people with mild OA participate in moderate intensity physical activity. Given that physical activities have been shown to reduce pain, improve quality of life, and have the potential to reduce the progression of joint damage, many people with OA are missing the benefits of this inexpensive intervention. Objective: The objectives of this study are (1) to develop a behavioral theory-informed Internet intervention called Osteoarthritis Physical Activity & Exercise Net (OPEN) for people with previously undiagnosed knee OA, and (2) to assess the efficacy of the OPEN website for improving physical activity participation through a proof-of-concept study. Methods: OPEN was developed based on the theory of planned behavior. Efficacy of this online intervention is being assessed by an ongoing proof-of-concept, single-blind randomized controlled trial in British Columbia, Canada. We are currently recruiting participants and plan to recruit a total of 252 sedentary people with previously undiagnosed knee OA using a set of validated criteria. Half of the participants will be randomized to use OPEN and receive an OA education pamphlet. The other half only will receive the pamphlet. Participants will complete an online questionnaire at baseline, 3 months, and 6 months about their participation in physical activities, health-related quality of life, and motivational outcomes. In addition, we will perform an aerobic fitness test in a sub-sample of participants (n=20 per study arm). In the primary analysis, we will use logistic regression to compare the proportion of participants reporting being physically active at or above the recommended level in the 2 groups, adjusting for baseline measurement, age, and sex. Results: This study evaluates a theory-informed behavioral intervention at a time when people affected with OA tend to be more motivated to adopt an active lifestyle (ie, at the early stage of OA). Our approach, which consisted of the identification of early knee OA followed immediately by an online intervention that directly targets physical inactivity, can be easily implemented across communities. Conclusions: Our online intervention directly targets physical inactivity at a time when the joint damage tends to be mild. If OPEN is found to be effective in changing long-term physical activity behaviors, it opens further opportunities to promote early diagnosis and to implement lifestyle interventions. Trial Registration: Clinicaltrial.gov: NCT01608282; http://clinicaltrials.gov/ct2/show/NCT01608282 (Archived by WebCite at http://www.webcitation.org/6G7sBBayI) %M 23659903 %R 10.2196/resprot.2553 %U http://www.researchprotocols.org/2013/1/e17/ %U https://doi.org/10.2196/resprot.2553 %U http://www.ncbi.nlm.nih.gov/pubmed/23659903