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JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed-indexed journal, publishing peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

JMIR Res Protoc is a journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (JMIR Impact Factor 2016: 5.175).

While the original focus was on eHealth studies, JMIR Res Protoc now publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions.

JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central.

Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort.

JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal.

JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols.

JMIR Res Protoc provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced.

JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods.

Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine.

Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!

 
 

Recent Articles:

  • The DIABEO app (montage). Source: Sanofi / Smartmockups.com; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/4/e66/; License: Creative Commons Attribution (CC-BY).

    DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial

    Abstract:

    Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Objective: Here, we present the protocol for a new study (Suivi A Grande Echelle d’une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. Methods: TELESAGE is a multicenter, double-randomized, open-label, three parallel–arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist’s task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. Results: The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. Conclusions: The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. Trial Registration: ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd)

  • Woman receiving contraceptive counseling. Source: Shutterstock; Copyright: Rocketclips, Inc; URL: https://www.shutterstock.com/image-photo/asian-physician-explaining-new-prescription-black-221885875?src=VR8kpRdOh-evz_ZLQiZpYg-1-7; License: Licensed by the authors.

    A Web-Based Decision Tool to Improve Contraceptive Counseling for Women With Chronic Medical Conditions: Protocol For a Mixed Methods Implementation Study

    Abstract:

    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)

  • Source: CDC Public Health Image Library; Copyright: Amanda Mills; URL: https://phil.cdc.gov/Details.aspx?pid=13979; License: Public Domain (CC0).

    An Exercise Intervention to Unravel the Mechanisms Underlying Insulin Resistance in a Cohort of Black South African Women: Protocol for a Randomized...

    Abstract:

    Background: The pathogenesis of type 2 diabetes (T2D) in black African women is complex and differs from that in their white counterparts. However, earlier studies have been cross-sectional and provide little insight into the causal pathways. Exercise training is consistently used as a model to examine the mechanisms underlying insulin resistance and risk for T2D. Objective: The objective of the study was to examine the mechanisms underlying the changes in insulin sensitivity and secretion in response to a 12-week exercise intervention in obese black South African (SA) women. Methods: A total of 45 obese (body mass index, BMI: 30-40 kg/m2) black SA women were randomized into a control (n=22) or experimental (exercise; n=23) group. The exercise group completed 12 weeks of supervised combined aerobic and resistance training (40-60 min, 4 days/week), while the control group maintained their typical physical activity patterns, and both groups were requested not to change their dietary patterns. Before and following the 12-week intervention period, insulin sensitivity and secretion (frequently sampled intravenous glucose tolerance test) and its primary and secondary determinants were measured. Dietary intake, sleep quality and quantity, physical activity, and sedentary behaviors were measured every 4 weeks. Results: The final sample included 20 exercise and 15 control participants. Baseline sociodemographics, cardiorespiratory fitness, anthropometry, cardiometabolic risk factors, physical activity, and diet did not differ between the groups (P>.05). Conclusions: The study describes a research protocol for an exercise intervention to understand the mechanisms underlying insulin sensitivity and secretion in obese black SA women and aims to identify causal pathways underlying the high prevalence of insulin resistance and risk for T2D in black SA women, targeting specific areas for therapeutic intervention. Trial Registration: Pan African Clinical Trial Registry PACTR201711002789113; http://www.pactr.org/ATMWeb/ appmanager/atm/atmregistry?_nfpb=true&_pageLabel=portals_app_atmregistry_portal_page_13 (Archived by WebCite at http://www.webcitation.org/6xLEFqKr0)

  • Using a mobile phone to collect patient data. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/4/e102/; License: Creative Commons Attribution (CC-BY).

    Capturing Ultraviolet Radiation Exposure and Physical Activity: Feasibility Study and Comparison Between Self-Reports, Mobile Apps, Dosimeters, and...

    Abstract:

    Background: Skin cancer is the most prevalent cancer in Australia. Skin cancer prevention programs aim to reduce sun exposure and increase sun protection behaviors. Effectiveness is usually assessed through self-report. Objective: It was the aim of this study to test the acceptance and validity of a newly developed ultraviolet radiation (UVR) exposure app, designed to reduce the data collection burden to research participants. Physical activity data was collected because a strong focus on sun avoidance may result in unhealthy reductions in physical activity. This paper provides lessons learned from collecting data from participants using paper diaries, a mobile app, dosimeters, and accelerometers for measuring end-points of UVR exposure and physical activity. Methods: Two participant groups were recruited through social and traditional media campaigns 1) Group A—UVR Diaries and 2) Group B—Physical Activity. In Group A, nineteen participants wore an UVR dosimeter wristwatch (University of Canterbury, New Zealand) when outside for 7 days. They also recorded their sun exposure and physical activity levels using both 1) the UVR diary app and 2) a paper UVR diary. In Group B, 55 participants wore an accelerometer (Actigraph, Pensacola, FL, USA) for 14 days and completed the UVR diary app. Data from the UVR diary app were compared with UVR dosimeter wristwatch, accelerometer, and paper UVR diary data. Cohen kappa coefficient score was used to determine if there was agreement between categorical variables for different UVR data collection methods and Spearman rank correlation coefficient was used to determine agreement between continuous accelerometer data and app-collected self-report physical activity. Results: The mean age of participants in Groups A (n=19) and B (n=55) was 29.3 and 25.4 years, and 63% (12/19) and 75% (41/55) were females, respectively. Self-reported sun exposure data in the UVR app correlated highly with UVR dosimetry (κ=0.83, 95% CI 0.64-1.00, P<.001). Correlation between self-reported UVR app and accelerometer-collected moderate to vigorous physical activity data was low (ρ=0.23, P=.10), while agreement for low-intensity physical activity was significantly different (ρ=-0.49, P<.001). Seventy-nine percent of participants preferred the app over the paper diary for daily self-report of UVR exposure and physical activity. Conclusions: This feasibility study highlights self-report using an UVR app can reliably collect personal UVR exposure, but further improvements are required before the app can also be used to collect physical activity data.

  • Source: Getty Images; Copyright: Getty Images; URL: https://www.gettyimages.com/license/478186083; License: Licensed by the authors.

    Comparison of Online Survey Recruitment Platforms for Hard-to-Reach Pregnant Smoking Populations: Feasibility Study

    Abstract:

    Background: Recruiting hard-to-reach populations for health research is challenging. Web-based platforms offer one way to recruit specific samples for research purposes, but little is known about the feasibility of online recruitment and the representativeness and comparability of samples recruited through different Web-based platforms. Objective: The objectives of this study were to determine the feasibility of recruiting a hard-to-reach population (pregnant smokers) using 4 different Web-based platforms and to compare participants recruited through each platform. Methods: A screener and survey were distributed online through Qualtrics Panel, Soapbox Sample, Reddit, and Amazon Mechanical Turk (mTurk). Descriptive statistics were used to summarize results of each recruitment platform, including eligibility yield, quality yield, income, race, age, and gestational age. Results: Of the 3847 participants screened for eligibility across all 4 Web-based platforms, 535 were eligible and 308 completed the survey. Amazon mTurk yielded the fewest completed responses (n=9), 100% (9/9) of which passed several quality metrics verifying pregnancy and smoking status. Qualtrics Panel yielded 14 completed responses, 86% (12/14) of which passed the quality screening. Soapbox Sample produced 107 completed surveys, 67% (72/107) of which were found to be quality responses. Advertising through Reddit produced the highest completion rate (n=178), but only 29.2% (52/178) of those surveys passed the quality metrics. We found significant differences in eligibility yield, quality yield, age, number of previous pregnancies, age of smoking initiation, current smokers, race, education, and income (P<.001). Conclusions: Although each platform successfully recruited pregnant smokers, results varied in quality, cost, and percentage of complete responses. Moving forward, investigators should pay careful attention to the percentage yield and cost of online recruitment platforms to maximize internal and external validity.

  • ACPTalk logo. Source: Image created by 360 South; Copyright: The Authors; URL: www.acptalk.com.au; License: Creative Commons Attribution (CC-BY).

    A Website Supporting Sensitive Religious and Cultural Advance Care Planning (ACPTalk): Formative and Summative Evaluation

    Abstract:

    Background: Advance care planning (ACP) promotes conversations about future health care needs, enacted if a person is incapable of making decisions at end-of-life that may be communicated through written documentation such as advance care directives. To meet the needs of multicultural and multifaith populations in Australia, an advance care planning website, ACPTalk, was funded to support health professionals in conducting conversations within diverse religious and cultural populations. ACPTalk aimed to provide religion-specific advance care planning content and complement existing resources. Objective: The purpose of this paper was to utilize the context, input, process, and product (CIPP) framework to conduct a formative and summative evaluation of ACPTalk. Methods: The CIPP framework was used, which revolves around 4 aspects of evaluation: context, input, process, and product. Context: health professionals’ solutions for the website were determined through thematic analysis of exploratory key stakeholder interviews. Included religions were determined through an environmental scan, Australian population statistics, and documentary analysis of project steering committee meeting minutes. Input: Project implementation and challenges were examined through documentary analysis of project protocols and meeting minutes. Process: To ensure religion-specific content was accurate and appropriate, a website prototype was built with content review and functionality testing by representatives from religious and cultural organizations and other interested health care organizations who completed a Web-based survey. Product: Website analytics were used to report utilization, and stakeholder perceptions were captured through interviews and a website survey. Results: Context: A total of 16 key stakeholder health professional (7 general practitioners, 2 primary health nurses, and 7 palliative care nurses) interviews were analyzed. Website solutions included religious and cultural information, communication ideas, legal information, downloadable content, and Web-based accessibility. Christian and non-Christian faiths were to be included in the religion-specific content. Input: Difficulties gaining consensus on religion-specific content were overcome by further state and national religious organizations providing feedback. Process: A total of 37 content reviewers included representatives of religious and cultural organizations (n=29), health care (n=5), and community organizations (n=3). The majority strongly agree or agree that the content used appropriate language and tone (92%, 34/37), would support health professionals (89%, 33/37), and was accurate (83%, 24/29). Product: Resource usage within the first 9 months was 12,957 page views in 4260 sessions; majority were (83.45%, 3555/4260) from Australia. A total of 107 Australian-based users completed the website survey; most felt information was accurate (77.6%, 83/107), easy to understand (82.2%, 88/107), useful (86.0%, 92/107), and appropriate (86.0%, 92/107). A total of 20 nurses (general practice n=10, palliative care n=8, and both disciplines n=2) participated in stakeholder interviews. Qualitative findings indicated overall positivity in relation to accessibility, functionality, usefulness, design, and increased knowledge of advance care planning. Recommended improvements included shortened content, a comparable website for patients and families, and multilingual translations. Conclusions: The CIPP framework was effectively applied to evaluate the development and end product of an advance care planning website.Although overall findings were positive, further advance care planning website development should consider the recommendations derived from this study.

  • Clinical practice guidelines in print form versus mobile apps. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/4/e105/; License: Creative Commons Attribution (CC-BY).

    Comparing a Mobile Decision Support System Versus the Use of Printed Materials for the Implementation of an Evidence-Based Recommendation: Protocol for a...

    Abstract:

    Background: The distribution of printed materials is the most frequently used strategy to disseminate and implement clinical practice guidelines, although several studies have shown that the effectiveness of this approach is modest at best. Nevertheless, there is insufficient evidence to support the use of other strategies. Recent research has shown that the use of computerized decision support presents a promising approach to address some aspects of this problem. Objective: The aim of this study is to provide qualitative evidence on the potential effect of mobile decision support systems to facilitate the implementation of evidence-based recommendations included in clinical practice guidelines. Methods: We will conduct a qualitative study with two arms to compare the experience of primary care physicians while they try to implement an evidence-based recommendation in their clinical practice. In the first arm, we will provide participants with a printout of the guideline article containing the recommendation, while in the second arm, we will provide participants with a mobile app developed after formalizing the recommendation text into a clinical algorithm. Data will be collected using semistructured and open interviews to explore aspects of behavioral change and technology acceptance involved in the implementation process. The analysis will be comprised of two phases. During the first phase, we will conduct a template analysis to identify barriers and facilitators in each scenario. Then, during the second phase, we will contrast the findings from each arm to propose hypotheses about the potential impact of the system. Results: We have formalized the narrative in the recommendation into a clinical algorithm and have developed a mobile app. Data collection is expected to occur during 2018, with the first phase of analysis running in parallel. The second phase is scheduled to conclude in July 2019. Conclusions: Our study will further the understanding of the role of mobile decision support systems in the implementation of clinical practice guidelines. Furthermore, we will provide qualitative evidence to aid decisions made by low- and middle-income countries’ ministries of health about investments in these technologies.

  • Ms Seblewongel Goa, a health extension worker in Wormuma Health Post, in Southern Nations, Nationalities, and Peoples' Region in Ethiopia. Source: Image created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/4/e99/; License: Creative Commons Attribution (CC-BY).

    Universal Versus Conditional Third Day Follow-Up Visit for Children With Nonsevere Unclassified Fever at the Community Level in Ethiopia: Protocol for a...

    Abstract:

    Background: Under the World Health Organization’s integrated community case management strategy, febrile children seen by community health workers (on day 1) without a diagnosable illness and without danger signs are advised to return on day 3, regardless of symptom resolution. This advice might be unnecessary and place additional time and cost burdens on caregivers and community health workers. However, the safety of not following up with respect to children with unclassified fever is unknown. Objective: The objective of this study is to establish the safety of conditional follow-up of nonsevere unclassified fever, that is, nonsevere illness with fever, no malaria, pneumonia, diarrhea, or danger signs, compared with universal follow-up on day 3, through a 2-arm cluster randomized controlled noninferiority trial. Methods: The study is being conducted in 3 districts in southwest Ethiopia. A total of 25 health facilities are randomized to one of the 2 intervention arms; all 144 health posts and 284 community health workers are included. All enrolled children are followed-up after 1 week (on day 8) for re-assessment. If still sick on day 8, additional follow-up takes place after 2 weeks (day 15) and 1 month (day 29). To demonstrate that there is no significant increase in the percentage of children deteriorating clinically, the sample size needed for a noninferiority margin of 4%, a power of 80%, an alpha of 5%, and a design effect of 3 is 4284 children with unclassified fever. Main outcome is treatment failure on day 8, defined as death, hospitalization, one or more danger signs, or persistent fever. Results: The project was funded in 2015 and enrollment was completed 2016. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. Conclusions: This study addresses the question as to whether there is any benefit in recommending universal follow-up among children seen for nonsevere unclassified fever, or whether parents can be counseled to return in the event of persistent fever, using a cluster randomized controlled trial design embedded in a national program. Outcomes will be relevant for policy makers and are important for the evaluation of current and future World Health Organization guidelines for the management of children with fever. Trial Registration: ClinicalTrials.gov NCT02926625; https://clinicaltrials.gov/ct2/show/NCT02926625 (Archived by WebCite at http://www.webcitation.org/6xrQWn50t)

  • Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/4/e95; License: Creative Commons Attribution (CC-BY).

    Recruitment of Participants and Delivery of Online Mental Health Resources for Depressed Individuals Using Tumblr: Pilot Randomized Control Trial

    Abstract:

    Background: Adolescents and young adults frequently post depression symptom references on social media; previous studies show positive associations between depression posts and self-reported depression symptoms. Depression is common among young people and this population often experiences many barriers to mental health care. Thus, social media may be a new resource to identify, recruit, and intervene with young people at risk for depression. Objective: The purpose of this pilot study was to test a social media intervention on Tumblr. We used social media to identify and recruit participants and to deliver the intervention of online depression resources. Methods: This randomized pilot intervention identified Tumblr users age 15-23 who posted about depression using the search term “#depress”. Eligible participants were recruited via Tumblr messages; consented participants completed depression surveys and were then randomized to an intervention of online mental health resources delivered via a Tumblr message, while control participants did not receive resources. Postintervention online surveys assessed resource access and usefulness and control groups were asked whether they would have liked to receive resources. Analyses included t tests. Results: A total of 25 participants met eligibility criteria. The mean age of the participants was 17.5 (SD 1.9) and 65% were female with average score on the Patient Health Questionnaire-9 of 17.5 (SD 5.9). Among the 11 intervention participants, 36% (4/11) reported accessing intervention resources and 64% (7/11) felt the intervention was acceptable. Among the 14 control participants, only 29% (4/14) of reported that receiving resources online would be acceptable (P=.02). Participants suggested anonymity and ease of use as important characteristics in an online depression resource. Conclusions: The intervention was appropriately targeted to young people at risk for depression, and recruitment via Tumblr was feasible. Most participants in the intervention group felt the social media approach was acceptable, and about a third utilized the online resources. Participants who had not experienced the intervention were less likely to find it acceptable. Future studies should explore this approach in larger samples. Social media may be an appropriate platform for online depression interventions for young people.

  • App homepage (montage). Source: The Authors / Pexels; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/3/e84/; License: Creative Commons Attribution (CC-BY).

    A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial

    Abstract:

    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)

  • Person engaging with REACH text messages. Source: Image created by the Authors; Copyright: Lyndsay A Nelson; URL: http://www.researchprotocols.org/2018/4/e92/; License: Creative Commons Attribution (CC-BY).

    Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial

    Abstract:

    Background: Nonadherence to self-care is common among patients with type 2 diabetes (T2D) and often leads to severe complications. Moreover, patients with T2D who have low socioeconomic status and are racial/ethnic minorities disproportionately experience barriers to adherence and poor outcomes. Basic phone technology (text messages and phone calls) provides a practical medium for delivering content to address patients’ barriers to adherence; however, trials are needed to explore long-term and sustainable effects of mobile phone interventions among diverse patients. Objective: The aim of this study is to evaluate the effects of mobile phone–based diabetes support interventions on self-care and hemoglobin A1c (HbA1c) among adults with T2D using a 3-arm, 15-month randomized controlled trial with a Type 1 hybrid effectiveness-implementation approach. The intervention arms are (1) Rapid Encouragement/Education And Communications for Health (REACH) and (2) REACH + Family-focused Add-on for Motivating Self-care (FAMS). Methods: We recruited primary care patients with T2D (N=512) from Federally Qualified Health Centers and an academic medical center, prioritizing recruitment of publicly insured and minority patients from the latter. Eligible patients were prescribed daily diabetes medication and owned a cell phone with text messaging capability. We excluded patients whose most recent HbA1c result within 12 months was <6.8% to support detection of intervention effects on HbA1c. Participants were randomly assigned to REACH only, REACH + FAMS, or the control condition. REACH provides text messages tailored to address patient-specific barriers to medication adherence based on the Information-Motivation-Behavioral skills model, whereas FAMS provides monthly phone coaching with related text message content focused on family and friend barriers to diet and exercise adherence. We collect HbA1c and self-reported survey data at baseline and at 3, 6, and 12 months, and again at 15 months to assess sustained changes. We will use generalized estimating equation models to test the effects of REACH (either intervention arm) on HbA1c relative to the control group, the potential additive effects of FAMS, and effects of either intervention on adherence to self-care behaviors and diabetes self-efficacy. Results: The trial is ongoing; recruitment closed December 2017. We plan to perform analyses on 6-month outcomes for FAMS in July 2018, and project to have 15-month data for REACH analyses in April 2019. Conclusions: Our study will be one of the first to evaluate a long-term, theory-based text messaging intervention to promote self-care adherence among racially/ethnically and socioeconomically diverse adults with T2D. Moreover, our study will assess the feasibility of a family-focused intervention delivered via mobile phones and compare the effects of text messaging alone versus text messaging plus phone coaching. Findings will advance our understanding of how interventions delivered by phone can benefit diverse patients with chronic conditions. Trial Registration: ClinicalTrials.gov NCT02409329; https://clinicaltrials.gov/ct2/show/NCT02409329 (Archived by WebCite at http://www.webcitation.org/6yHkg9SSl); NCT02481596; https://clinicaltrials.gov/ct2/show/NCT02481596 (Archived by WebCite at http://www.webcitation.org/6yHkj9XD4)

  • A text message to minimize no show at pediatric outpatient clinics in Pakistan. Source: Wikimedia Commons; Copyright: Biswarup Ganguly; URL: https://commons.wikimedia.org/wiki/File:Kid_Touching_Smartphone_-_Dum_Dum_-_Kolkata_2012-04-22_1768.JPG; License: Creative Commons Attribution (CC-BY).

    Evaluating the Effectiveness of Text Messaging and Phone Call Reminders to Minimize No Show at Pediatric Outpatient Clinics in Pakistan: Protocol for a...

    Abstract:

    Background: Missing health care appointments without canceling in advance results in a no show, a vacant appointment slot that cannot be offered to others. No show can be reduced by reminding patients about their appointment in advance. In this regard, mobile health (mHealth) strategy is to use text messaging (short message service, SMS), which is available on all cellular phones, including cheap low-end handsets. Nonattendance for appointments in health care results in wasted resources and disturbs the planned work schedules. Objectives: The purpose of this study is to evaluate the efficacy of the current text messaging (SMS) and call-based reminder system and further explore how to improve the attendance at the pediatric outpatient clinics. The primary objectives are to (1) determine the efficacy of the current clinic appointment reminder service at pediatric outpatient clinics at Aga Khan University Hospital, (2) assess the mobile phone access and usage among caregivers visiting pediatrics consultant clinics, and (3) explore the perception and barriers of parents regarding the current clinic appointment reminder service at the pediatric outpatient clinics at Aga Khan University Hospital. Methods: The study uses a mixed-method design that consists of 3 components: (1) retrospective study (component A) which aims to determine the efficacy of text messaging (SMS) and phone call–based reminder service on patient’s clinic attendance during January to June 2017 (N=58,517); (2) quantitative (component B) in which a baseline survey will be conducted to assess the mobile phone access and usage among parents/caregivers of children visiting pediatrics consultant clinics (n=300); and (3) qualitative (component C) includes in-depth interviews and focus group discussion with parents/caregivers of children visiting the pediatric consultancy clinic and with health care providers and administrative staff. Main constructs will be to explore perceptions and barriers related to existing clinic appointment reminder service. Ethics approval has been obtained from the Ethical Review Committee, Aga Khan University, Pakistan (4770-Ped-ERC-17). Results: Results will be disseminated to pediatric quality public health and mHealth communities through scientific meetings and through publications, nationally and internationally. Conclusions: This study will provide insight regarding efficacy of using mHealth-based reminder services for patient’s appointments in low- and middle-income countries setup. The finding of this study will be used to recommend further enhanced mHealth-based solutions to improve patient appointments and decrease no show.

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  • Using an mHealth App to Transition Care of Type-1 Diabetes from Parents to Teens: Protocol for a Pilot Study

    Date Submitted: Apr 17, 2018

    Open Peer Review Period: Apr 19, 2018 - May 3, 2018

    Background: Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people with T1D are diagnosed at a young age and parents have to take on the responsibility of T1D man...

    Background: Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people with T1D are diagnosed at a young age and parents have to take on the responsibility of T1D management. Eventually, the child must begin to transition to self-management. Adolescents often struggle to take on responsibility for all the necessary tasks to successfully self-manage their T1D. In fact, approximately three-quarters of adolescents are not achieving ADA HbA1c targets. This lack of adherence can lead to negative health outcomes, such as the development of diabetic ketoacidosis, increased infections, and hospitalizations. Objective: The goals of this interdisciplinary proposal are: (1) to develop a unique and theory-driven technology using a mobile phone application (app) to promote self-management behaviors for adolescents aged 10 to 15 years with T1D and their parents; and (2) to explore the feasibility and impact of the self-management mobile app. Methods: This study has two phases: app development and pilot testing. In the app development phase, the app will be conceptualized and a prototype will be tested. In phase two, the mobile app will undergo pilot testing to determine its feasibility and impact on diabetes self-management. Results: The pilot test was launched in September 2017. Data collection is underway and results are forthcoming. Conclusions: Adolescents with type 1 diabetes and their parents often struggle during the transition from parent care to adolescent self-management. This transition to young adulthood is challenging for all families, but families facing the added complexity of diabetes management often find this time especially challenging. The proposed intervention aims to shift diabetes management responsibility to the adolescent and increase their independence, while encouraging parents to remain engaged and supportive of their adolescent in an effort to ease some difficulties of this challenging time. Clinical Trial: ClinicalTrials.gov Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens Identifier: NCT03436628 https://clinicaltrials.gov/ct2/show/NCT03436628

  • Protocol for the development and pilot evaluation of a smartphone-delivered peer physical activity counselling program for individuals with spinal cord injury.

    Date Submitted: Apr 17, 2018

    Open Peer Review Period: Apr 19, 2018 - May 3, 2018

    Background: Leisure-time physical activity (LTPA) is a critical component of a healthy lifestyle for individuals with spinal cord injury (SCI). However, most individuals are not sufficiently active to...

    Background: Leisure-time physical activity (LTPA) is a critical component of a healthy lifestyle for individuals with spinal cord injury (SCI). However, most individuals are not sufficiently active to accrue health benefits. The Active Living Lifestyles program for individuals with SCI who use manual wheelchairs (ALLWheel) targets important psychological factors that are associated with LTPA uptake and adherence, while overcoming some barriers associated with participation restrictions. Objective: To describe the protocol for the development and evaluation of the ALLWheel program for individuals with SCI who use manual wheelchairs. Methods: Complete the first three stages of the Medical Research Council Framework for developing and evaluating complex interventions (i.e., pre-clinical, modeling, exploratory). The pre-clinical phase will consist of scoping and systematic reviews and review of theory. The intervention will be modelled by expert opinions and consensus through focus groups and Delphi surveys with individuals with SCI, clinicians, and community partners. Finally, the feasibility and potential influence of the ALLWheel program on LTPA and psychological outcomes will be evaluated. Results: This project is funded by the Craig H Neilsen Foundation, the Fonds de Recherche du Québec – Santé, and the Canadian Disability Participation Project and is currently underway. Conclusions: Using peer trainers and smartphone technology may help to cultivate autonomy-supportive environments that also enhance self-efficacy. Following a framework for developing and evaluating a novel intervention, which includes input from stakeholder input at all stages, will ensure the final product (i.e., a replicable intervention) is desirable for knowledge users and ready for evaluation in a RCT. If effective, the ALLWheel program has the potential to reach a large number of individuals with SCI to promote LTPA uptake and adherence. Clinical Trial: N/A

  • Community-Based, Point-of-Care Sexually Transmitted Infection Screening Among High-Risk Adolescents in Los Angeles and New Orleans: Study Protocol, Adolescent Medicine Trials Network

    Date Submitted: Apr 17, 2018

    Open Peer Review Period: Apr 18, 2018 - May 2, 2018

    Background: Sexually transmitted infection (STI) rates are increasing in the United States, with approximately half of new infections occurring among adolescents age 15-24 years. Gay, bisexual, and tr...

    Background: Sexually transmitted infection (STI) rates are increasing in the United States, with approximately half of new infections occurring among adolescents age 15-24 years. Gay, bisexual, and transgender youth (GBTY), homeless youth, and youth with histories of drug use, mental health disorders, and incarceration are all at uniquely high risk for STIs. However, these adolescents often lack access to sexual health services. In this study, we are using point-of-care STI tests in community-based settings to screen for and treat STIs in adolescents. Methods: We are recruiting 1500 HIV-uninfected youth and 220 HIV-infected youth from homeless shelters, GBTY organizations, and community health centers in Los Angeles, California and New Orleans, Louisiana. Study participants receive STI screening every 4 months for 24 months. STI screening includes rapid HIV, syphilis, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Hepatitis C Virus testing. Trained paraprofessionals conduct all STI testing. When a participant screens positive for an STI, they are either linked to a partner medical clinic or provided with same-day antibiotic therapy and expedited partner therapy. We monitor STI prevalence among study participants, as well as point-of-care test performance, linkage-to-care, and treatment outcomes. Discussion: As STI rates continue to rise, it is important to improve access to screening and treatment services, particularly for high-risk adolescents. In this study, we aim to evaluate the use of point-of-care STI diagnostic tests in community-based organizations. We hope to determine the prevalence of STIs among those adolescents and evaluate the effectiveness of community-based STI screening programs.

  • A Randomized Controlled Trial to Evaluate a Stepped Care Intervention to Suppress Viral Load Among Youth Living with HIV

    Date Submitted: Apr 16, 2018

    Open Peer Review Period: Apr 18, 2018 - May 2, 2018

    Background: Among youth living with HIV (YLH) aged 12-24 years old linked to health care, only 30% to 40% are virally suppressed. YLH must achieve viral suppression, in order to reduce the probability...

    Background: Among youth living with HIV (YLH) aged 12-24 years old linked to health care, only 30% to 40% are virally suppressed. YLH must achieve viral suppression, in order to reduce the probability of infecting others, as well as increasing the length and quality of their own life. Objective: We are conducting a randomized controlled trial to evaluate the efficacy of an Enhanced Standard Care condition (n = 110) compared to a Stepped Care Intervention condition (n = 110) to increase viral suppression among YLH. Methods: YLH (N = 220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community based organizations in Los Angeles, CA and New Orleans, LA, USA. YLH will be randomly assigned to one of two study conditions: 1) Enhanced Standard Care: which includes standard clinical care plus an Automated Messaging and Monitoring Intervention (AMMI); or, 2) a Stepped Care: which includes three levels of intervention (1-AMMI; 2- Peer Support via social media plus AMMI; or a 3-Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at four-month intervals for 24 months. For the Stepped Care intervention group, those who do not achieve viral suppression at any four-month assessment will “step” up to the next level of intervention. Secondary outcomes will be sexually transmitted infections (STIs), serious substance abuse, retention in care, and antiretroviral therapy (ART) adherence. Results: N/A Conclusions: This is the first known application of a stepped care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost effective method of helping YLH achieve viral suppression and improve their quality of life. Clinical Trial: www.clinicaltrials.gov registration # NCT03109431 registered April 12, 2017

  • The effectiveness of a co-designed, culturally-tailored mHealth tool to support healthy lifestyles in Māori and Pasifika communities in New Zealand: Study protocol of a cluster-randomised controlled trial

    Date Submitted: Apr 15, 2018

    Open Peer Review Period: Apr 17, 2018 - May 1, 2018

    Background: New Zealand urgently needs scalable, effective healthy lifestyle support programmes tailored to the needs and lived contexts of Māori and Pasifika communities. Objective: The primary obje...

    Background: New Zealand urgently needs scalable, effective healthy lifestyle support programmes 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@ smartphone app and website) on key risk factors and behaviours associated with an increased risk of non-communicable disease (diet, physical activity, smoking and alcohol consumption) compared to a control condition. Methods: A 12-week, community-based, two-arm, cluster randomised controlled trial will be conducted across New Zealand January to December 2018. Participants (target n=1280; 64 clusters [32 Māori, 32 Pasifika]; 32 clusters per arm [16 Māori, 16 Pasifika]; 20 participants per cluster) will be individuals aged 18 years and older 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 smartphone, tablet or laptop/computer and to the internet. Clusters are identified by Community Coordinators and will be randomly assigned (1:1 ratio) to one of two groups: 1) the full OL@-OR@ app, or 2) a control version of the app (data collection only plus a once-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 4- and 12-weeks post randomisation. The primary outcome is adherence to healthy lifestyle behaviours measured using a self-reported composite health behaviour score at 12 weeks, that assesses smoking behaviour, 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 OL@-OR@ tool. Results: The trial started recruitment on 22/01/2018 and is currently ongoing. Recruitment is expected to take six months (protocol version 3, 11/04/2018. Trial findings are expected to be available December 2018 Conclusions: Currently there are no scalable, evidence-based tools to support Māori or Pasifika who want to improve their eating habits, lose weight, or be more active. This wait-list controlled, cluster randomised trial will assess the effectiveness of a co-designed, culturally tailored mHealth tool to support healthy lifestyles. Clinical Trial: Australia New Zealand Clinical Trials Register ACTRN12617001484336. Registered on 20/10/2017; http://www.ANZCTR.org.au/ACTRN12617001484336.aspx.

  • A Tale of Two Cities: Development of an electronic data collection system to support a large-scale HIV behavioral intervention trial

    Date Submitted: Apr 13, 2018

    Open Peer Review Period: Apr 14, 2018 - Apr 28, 2018

    Background: Advancing technology has increased functionality and permitted more complex study designs for behavioral interventions. Investigators need to keep pace with these technological advances in...

    Background: Advancing technology has increased functionality and permitted more complex study designs for behavioral interventions. Investigators need to keep pace with these technological advances in order for Electronic Data Capture (EDC) systems to be appropriately executed and utilized at full capacity in research settings. Mobile technology allows EDC systems to collect near real-time data from study participants; deliver intervention directly to participants’ personal mobile devices; monitor staff activity; and facilitate near real-time decision making during study implementation. Objective: This paper presents the infrastructure of an EDC system that was designed to support a multi-site HIV bio-behavioral intervention trial in Los Angeles and New Orleans (ATN CARES). We provide an overview of how multiple EDC functions can be integrated into a single EDC system to support large-scale intervention trials. Methods: The CARES EDC system is designed to monitor and document multiple study functions, i.e. screening, recruitment, retention, intervention delivery, and outcome assessment. SMS messaging and nearly all data collection are supported by the EDC system. The system functions on mobile phone, tablet, and web-browsers. Results: ATN CARES is enrolling study participants and collecting baseline and follow-up data through the EDC system. In addition to data collection, the EDC system is being used to generate multiple reports that inform recruitment planning, budgeting, intervention quality and field staff supervision. The EDC system is supporting both incoming and outgoing text messages and offers a high level of data security. Intervention design details are also influenced by EDC system platform capabilities and constraints. Challenges of using the EDC systems are addressed through programming updates and training on how to improve data quality. Conclusions: There are three key considerations in the development of an EDC system for an intervention trial. First, it needs to be decided if the flexibility provided by the development of a study-specific in-house EDC system is needed relative to the utilization of an existing commercial platform that requires less in-house programming expertise. Second, a single EDC system may not provide all functionality. ATN CARES is using a main EDC system for data collection, SMS interventions and case management and a separate online platform to support an online peer-support intervention. Decisions need to be made about the functionality that is crucial for the EDC system to handle and what functionality can be handled by other systems. Third, data security is a priority but needs to be balanced with the need for flexible intervention delivery. For example, ATN CARES is delivering SMS text messages to study participants’ mobile phones. EDC data security protocols should be developed with guidance from security experts and from formative consulting with the target study population as to their perceptions and needs.

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