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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 2017: 4.671).

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.

JRP is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?

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:

  • selfBACK user doing the exercise program. Source: Image created by the Authors; Copyright: Kai T Dragland / NTNU; URL: http://www.researchprotocols.org/2018/7/e167/; License: Creative Commons Attribution (CC-BY).

    A Decision Support System to Enhance Self-Management of Low Back Pain: Protocol for the selfBACK Project

    Abstract:

    Background: Low back pain (LBP) is a leading cause of disability worldwide. Most patients with LBP encountered in primary care settings have nonspecific LBP, that is, pain with an unknown pathoanatomical cause. Self-management in the form of physical activity and strength and flexibility exercises along with patient education constitute the core components of the management of nonspecific LBP. However, the adherence to a self-management program is challenging for most patients, especially without feedback and reinforcement. Here we outline a protocol for the design and implementation of a decision support system (DSS), selfBACK, to be used by patients themselves to promote self-management of LBP. Objective: The main objective of the selfBACK project is to improve self-management of nonspecific LBP to prevent chronicity, recurrence and pain-related disability. This is achieved by utilizing computer technology to develop personalized self-management plans based on individual patient data. Methods: The decision support is conveyed to patients via a mobile phone app in the form of advice for self-management. Case-based reasoning (CBR), a technology that utilizes knowledge about previous cases along with data about the current patient case, is used to tailor the advice to the current patient, enabling a patient-centered intervention based on what has and has not been successful in previous patient cases. The data source for the CBR system comprises initial patient data collected by a Web-based questionnaire, weekly patient reports (eg, symptom progression), and a physical activity-detecting wristband. The effectiveness of the selfBACK DSS will be evaluated in a multinational, randomized controlled trial (RCT), targeting care-seeking patients with nonspecific LBP. A process evaluation will be carried out as an integral part of the RCT to document the implementation and patient experiences with selfBACK. Results: The selfBACK project was launched in January 2016 and will run until the end of 2020. The final version of the selfBACK DSS will be completed in 2018. The RCT will commence in February 2019 with pain-related disability at 3 months as the primary outcome. The trial results will be reported according to the CONSORT statement and the extended CONSORT-EHEALTH checklist. Exploitation of the results will be ongoing throughout the project period based on a business plan developed by the selfBACK consortium. Tailored digital support has been proposed as a promising approach to improve self-management of chronic disease. However, tailoring self-management advice according to the needs, motivation, symptoms, and progress of individual patients is a challenging task. Here we outline a protocol for the design and implementation of a stand-alone DSS based on the CBR technology with the potential to improve self-management of nonspecific LBP. Conclusions: The selfBACK project will provide learning regarding the implementation and effectiveness of an app-based DSS for patients with nonspecific LBP. Registered Report Identifier: RR1-10.2196/9379

  • Source: Dreamstime; Copyright: Iofoto; URL: https://www.dreamstime.com/stock-images-father-daughter-phone-image12543864; License: Licensed by the authors.

    The Family Check-Up Online Program for Parents of Middle School Students: Protocol for a Randomized Controlled Trial

    Abstract:

    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

  • Source: The Authors / Placeit.net; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/7/e166/; License: Creative Commons Attribution (CC-BY).

    Toward Increasing Engagement in Substance Use Data Collection: Development of the Substance Abuse Research Assistant App and Protocol for a Microrandomized...

    Abstract:

    Background: Substance use is an alarming public health issue associated with significant morbidity and mortality. Adolescents and emerging adults are at particularly high risk because substance use typically initiates and peaks during this developmental period. Mobile health apps are a promising data collection and intervention delivery tool for substance-using youth as most teens and young adults own a mobile phone. However, engagement with data collection for most mobile health applications is low, and often, large fractions of users stop providing data after a week of use. Objective: Substance Abuse Research Assistant (SARA) is a mobile application to increase or sustain engagement of substance data collection overtime. SARA provides a variety of engagement strategies to incentivize data collection: a virtual aquarium in the app grows with fish and aquatic resources; occasionally, funny or inspirational contents (eg, memes or text messages) are provided to generate positive emotions. We plan to assess the efficacy of SARA’s engagement strategies over time by conducting a micro-randomized trial, where the engagement strategies will be sequentially manipulated. Methods: We aim to recruit participants (aged 14-24 years), who report any binge drinking or marijuana use in the past month. Participants are instructed to use SARA for 1 month. During this period, participants are asked to complete one survey and two active tasks every day between 6 pm and midnight. Through the survey, we assess participants’ daily mood, stress levels, loneliness, and hopefulness, while through the active tasks, we measure reaction time and spatial memory. To incentivize and support the data collection, a variety of engagement strategies are used. First, predata collection strategies include the following: (1) at 4 pm, a push notification may be issued with an inspirational message from a contemporary celebrity; or (2) at 6 pm, a push notification may be issued reminding about data collection and incentives. Second, postdata collection strategies include various rewards such as points which can be used to grow a virtual aquarium with fishes and other treasures and modest monetary rewards (up to US $12; US $1 for each 3-day streak); also, participants may receive funny or inspirational content as memes or gifs or visualizations of prior data. During the study, the participants will be randomized every day to receive different engagement strategies. In the primary analysis, we will assess whether issuing 4 pm push-notifications or memes or gifs, respectively, increases self-reporting on the current or the following day. Results: The microrandomized trial started on August 21, 2017 and the trial ended on February 28, 2018. Seventy-three participants were recruited. Data analysis is currently underway. Conclusions: To the best of our knowledge, SARA is the first mobile phone app that systematically manipulates engagement strategies in order to identify the best sequence of strategies that keep participants engaged in data collection. Once the optimal strategies to collect data are identified, future versions of SARA will use this data to provide just-in-time adaptive interventions to reduce substance use among youth. Trial Registration: ClinicalTrials.gov NCT03255317; https://clinicaltrials.gov/show/NCT03255317 (Archived by WebCite at http://www.webcitation.org/70raGWV0e) Registered Report Identifier: RR1-10.2196/9850

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/7/e10000/; License: Creative Commons Attribution (CC-BY).

    Community Volunteer Support for Families With Young Children: Protocol for the Volunteer Family Connect Randomized Controlled Trial

    Abstract:

    Background: Use of community volunteers to support vulnerable families is a widely employed strategy with a long history. However, there has been minimal formal scientific investigation into the effectiveness of volunteer home visiting programs for families. There is also a need for research examining whether volunteer home visiting leads to improved outcomes for volunteers. Objective: The objective of this paper is to describe the research protocol for a pragmatic randomized controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home visiting program designed to support families of young children who experience social isolation or a lack of parenting confidence and skills. The project is being conducted in partnership with 3 leading not-for-profit organizations, designed to contribute to the body of evidence that informs decisions about appropriate family support services according to the level of need. It is the first study to examine outcomes for both the families and the volunteers who deliver the service. Methods: The RCT is being conducted in 7 sites across Australia. We aim to recruit 300 families to the study: 150 control (services as usual) and 150 intervention (services as usual + volunteer home visiting) families. Intervention families will receive the service for 3-12 months according to their needs, and all participants will complete 6 data collection points over 15 months. A minimum of 80 volunteers will also be recruited, along with a matched community comparison group. The volunteers will complete 3 data collection points over 12 months. Primary outcomes include community connectedness and parenting competence. Secondary outcomes include parent physical and mental health; general parent well-being; parent empowerment; the child-parent relationship; sustainability of family routines; child immunization; child nutrition or breastfeeding; number of accidental injury reports; and volunteer health, well-being, and community connectedness. Results: This effectiveness trial was funded in 2016, and we aim to complete data collection by the end of 2018. The first results are expected to be submitted early in 2019. Conclusions: There is a need to rigorously assess volunteer home visiting and whether it has a unique and important role on the service landscape, complementary to professional services. This research is the first trial of a volunteer home visiting program to be conducted in Australia and one of the largest of its kind worldwide. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12616000396426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370304 (Archived by WebCite athttp://www.webcitation.org/70q42fU7V) Registered Report Identifier: RR1-10.2196/1000

  • Hands on during workshop. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/7/e165/; License: Creative Commons Attribution (CC-BY).

    The Development of Complex Digital Health Solutions: Formative Evaluation Combining Different Methodologies

    Abstract:

    Background: The development of digital health solutions for current health care settings requires an understanding of the complexities of the health care system, organizational setting, and stakeholder groups and of the underlying interplay between stakeholders and the technology. The digital health solution was founded on the basis of an information and communication technology platform and point-of-care devices enabling home-based monitoring of disease progression and treatment outcome for patients with rheumatoid arthritis (RA). Objective: The aim of this paper is to describe and discuss the applicability of an iterative evaluation process in guiding the development of a digital health solution as a technical and organizational entity in three different health care systems. Methods: The formative evaluation comprised the methodologies of contextual understanding, participatory design, and feasibility studies and included patients, healthcare professionals, and hardware and software developers. In total, the evaluation involved 45 patients and 25 health care professionals at 3 clinical sites in Europe. Results: The formative evaluation served as ongoing and relevant input to the development process of the digital health solution. Through initial field studies key stakeholder groups were identified and knowledge obtained about the different health care systems, the professional competencies involved in routine RA treatment, the clinics’ working procedures, and the use of communication technologies. A theory-based stakeholder evaluation achieved a multifaceted picture of the ideas and assumptions held by stakeholder groups at the three clinical sites, which also represented the diversity of three different language zones and cultures. Experiences and suggestions from the patients and health care professionals were sought through participatory design processes and real-life testing and actively used for adjusting the visual, conceptual, and practical design of the solution. The learnings captured through these activities aided in forming the solution and in developing a common understanding of the overall vision and aim of this solution. During this process, the 3 participating sites learned from each other’s feed-back with the ensuing multicultural inspiration. Moreover, these efforts also enabled the consortium to identify a ‘tipping point’ during a pilot study, revealing serious challenges and a need for further development of the solution. We achieved valuable learning during the evaluation activities, and the remaining challenges have been clarified more extensively than a single-site development would have discovered. The further obstacles have been defined as has the need to resolve these before designing and conducting a real-life clinical test to assess the outcome from a digital health solution for RA treatment. Conclusions: A formative evaluation process with ongoing involvement of stakeholder groups from 3 different cultures and countries have helped to inform and influence the development of a novel digital health solution, and provided constructive input and feedback enabling the consortium to control the development process.

  • Beta version of the newly developed, culturally-tailored, interactive website for Black/African American and Hispanic/Latino men who have sex with men. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/7/e11047/; License: Creative Commons Attribution (CC-BY).

    Using eHealth to Reach Black and Hispanic Men Who Have Sex With Men Regarding Treatment as Prevention and Preexposure Prophylaxis: Protocol for a Small...

    Abstract:

    Background: Black and Hispanic men who have sex with men in the United States continue to be disproportionately affected by HIV and AIDS. Uptake of and knowledge about biobehavioral HIV prevention approaches, such as treatment as prevention and preexposure prophylaxis, are especially low in these populations. eHealth campaigns and social media messaging about treatment as prevention and preexposure prophylaxis may help to fill this gap in knowledge and lead to increased uptake of such strategies; however, no evidence exists of the effects of these targeted forms of communication on treatment as prevention and preexposure prophylaxis uptake in these populations. Objective: We describe the protocol for a 3-part study aiming to develop and evaluate an eHealth intervention with information about treatment as prevention and preexposure prophylaxis for HIV-positive and HIV-negative black and Hispanic men who have sex with men. Methods: Phases 1 and 2 will involve focus groups and cognitive interviews with members of the target populations, which we will use to create a culturally tailored, interactive website and applicable social media messaging for these men. Phase 3 will be a small randomized controlled trial of the eHealth intervention, in which participants will receive guided social media messages plus the newly developed website (active arm) or the website alone (control arm), with assessments at baseline and 6 months. Results: Participant recruitment began in August 2017 and will end in August 2020. Conclusions: Public health interventions are greatly needed to increase knowledge about and uptake of biobehavioral HIV prevention strategies such as treatment as prevention and preexposure prophylaxis among black and Hispanic men who have sex with men. eHealth communication campaigns offer a strategy for engaging these populations in health communication about biobehavioral HIV prevention. Trial Registration: ClinicalTrials.gov NCT03404531; https://www.clinicaltrials.gov/ct2/show/NCT03404531 (Archived by WebCite at http://www.webcitation.org/70myofp0R). Registered Report Identifier: RR1-10.2196/11047

  • Study logo. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/7/e10174/; License: Licensed by JMIR.

    Reducing HIV Vulnerability Through a Multilevel Life Skills Intervention for Adolescent Men (The iREACH Project): Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Few HIV interventions have demonstrated efficacy in reducing HIV risk among adolescent men who have sex with men (AMSM), and fewer still have recognized the unique needs of AMSM based on race/ethnicity or geographical setting. Recognizing that youths’ HIV vulnerability is intricately tied to their development and social context, delivering life skills training during adolescence might delay the onset or reduce the consequences of risk factors for HIV acquisition and equip AMSM with the skills to navigate HIV prevention. This protocol describes the development and testing of iREACH, an online multilevel life skills intervention for AMSM. Objective: This randomized controlled trial (RCT) aims to test the efficacy of an online-delivered life skills intervention, iREACH, on cognitive and behavioral HIV-related outcomes for AMSM. Methods: iREACH is a prospective RCT of approximately 600 cisgender adolescent males aged 13 to 18 years who report same-sex attractions. The intervention will be tested with a racial/ethnically diverse sample (≥50% racial/ethnic minority) of AMSM living in four regions in the United States: (1) Chicago to Detroit, (2) Washington, DC to Atlanta, (3) San Francisco to San Diego, and (4) Memphis to New Orleans. Results: This project is currently recruiting participants. Recruitment began in March 2018. Conclusions: iREACH represents a significant innovation in the development and testing of a tailored life skills-focused intervention for AMSM, and has the potential to fill a significant gap in HIV prevention intervention programming and research for AMSM. Registered Report Identifier: RR1-10.2196/10174

  • Source: Wikimedia Commons (Samuel Bendet); Copyright: US Air Force; URL: https://commons.wikimedia.org/wiki/File:Laparoscopic_stomach_surgery.jpg; License: Public Domain (CC0).

    Effects of Deep Versus Moderate Neuromuscular Blockade in Laparoscopic Gynecologic Surgery on Postoperative Pain and Surgical Conditions: Protocol for a...

    Abstract:

    Background: Postoperative pain, especially shoulder pain, is commonly reported after laparoscopic gynecologic procedures. Some studies suggest that a lower insufflation pressure may reduce the risk of postoperative pain; however, there is no agreement on the optimal pneumoperitoneum pressure during gynecologic laparoscopic surgery or whether lower pressure would lead to clinically significant improvements without increasing operative complications. Questions remain regarding the clinical significance of improvements, safety, and cost-effectiveness of deep neuromuscular blockade with low-pressure pneumoperitoneum. Objective: The primary objective of this study was to assess the superiority of anesthesia with deep neuromuscular blockade with pneumoperitoneum 8 mm Hg over moderate blockade with pneumoperitoneum 12 mm Hg in terms of overall pain 24 hours after surgery in adult women undergoing pelvic surgery for hysterectomy or benign adnexal diseases. Effects on the intensity and timing of postoperative pain in specific locations, surgeon satisfaction, respiratory and hemodynamic stability, operating times, and direct and indirect costs will be assessed. Methods: In this multicenter, randomized controlled trial with a superiority design, 300 patients will be randomly allocated in the ratio 1:1 to moderate neuromuscular blockade with a target insufflation pressure of 12 mm Hg or deep neuromuscular blockade with a target insufflation pressure of 8 mm Hg, with stratification by type of surgery and clinical center. The patient, the statistician, and the nurse who will assess the primary endpoint will be blinded to the allocation. Results: Recruitment to this trial is expected to open in June 2018 and is expected to close in June 2019. Conclusions: This study is designed to confirm the reported benefits of postoperative pain and provide additional data needed to address questions regarding the effects of this intervention on operating theater management and direct and indirect costs. Strengths of this protocol include the large sample size distributed among diverse institutions across the Italian territory and the collection and analysis of data on numerous secondary objectives. Limitations include the possible introduction of bias because the surgeon and anesthesiologist are not blinded to the intervention. Registered Report Identifier: RR1-10.2196/9277

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/older-couple-in-retirement-home-holding-hands_2272114.htm#term=old%20hand%20holding&page=1&position=4; License: Licensed by JMIR.

    Characteristics of Cognitive Behavioral Therapy for Older Adults Living in Residential Care: Protocol for a Systematic Review

    Abstract:

    Background: The prevalence rates of depressive and anxiety disorders are high in residential aged care settings. Older adults in such settings might be prone to these disorders because of losses associated with transitioning to residential care, uncertainty about the future, as well as a decline in personal autonomy, health, and cognition. Cognitive behavioral therapy (CBT) is efficacious in treating late-life depression and anxiety. However, there remains a dearth of studies examining CBT in residential settings compared with community settings. Typically, older adults living in residential settings have higher care needs than those living in the community. To date, no systematic reviews have been conducted on the content and the delivery characteristics of CBT for older adults living in residential aged care settings. Objective: The objective of this paper is to describe the systematic review protocol on the characteristics of CBT for depression and/or anxiety for older adults living in residential aged care settings. Methods: This protocol was developed in compliance with the recommendations of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Studies that fulfill the inclusion criteria will be identified by systematically searching relevant electronic databases, reference lists, and citation indexes. In addition, the PRISMA flowchart will be used to record the selection process. A pilot-tested data collection form will be used to extract and record data from the included studies. Two reviewers will be involved in screening the titles and abstracts of retrieved records, screening the full text of potentially relevant reports, and extracting data. Then, the delivery and content characteristics of different CBT programs of the included studies, where available, will be summarized in a table. Furthermore, the Downs and Black checklist will be used to assess the methodological quality of the included studies. Results: Systematic searches will commence in May 2018, and data extraction is expected to commence in July 2018. Data analyses and writing will happen in October 2018. Conclusions: In this section, the limitations of the systematic review will be outlined. Clinical implications for treating late-life depression and/or anxiety, and implications for residential care facilities will be discussed. Trial Registration: PROSPERO 42017080113; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=80113 (Archived by WebCite at http://www.webcitation.org/70dV4Qf54) Registered Report Identifier: RR1-10.2196/9902

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/6/e162/; License: Licensed by JMIR.

    Identifying Barriers and Facilitators of 13 mHealth Projects in North America and Africa: Protocol for a 5-Year Implementation Science Study

    Abstract:

    Background: Although many mHealth interventions have shown efficacy in research, few have been effectively implemented and sustained in real-world health system settings. Despite this programmatic gap, there is limited conclusive evidence identifying the factors that affect the implementation and successful integration of mHealth into a health system. Objective: The aim of this study is to examine the individual, organizational, and external level factors associated with the effective implementation of WelTel, an mHealth intervention designed to support outpatient medication adherence and engagement in care in Africa and North America. Methods: We will adopt the Consolidated Framework for Implementation Research (CFIR) constructs for evaluation of mHealth implementation including a scoring and monitoring system. We will apply the adapted tool to identify facilitators and barriers to implementation of the WelTel mHealth intervention in order to determine how the technology platform is perceived, diffused, adapted, and used by different mHealth project teams and health system actors in Africa and North America. We will use a mixed-methods approach to quantitatively test whether the factors identified in the CFIR framework are associated with the successful uptake of the mHealth intervention toward implementation goals. We will triangulate these data through interviews and focus group discussion with project stakeholders, exploring factors associated with successful implementation and sustainment of these interventions. Results: The development of the customized CFIR is finalized and currently is in pilot testing. The initial results of the use of the tool in those 13 implementations will be available in 2019. Continuous conference and peer- reviewed publications will be published in the coming years. Conclusions: The results of this study will provide an in-depth understanding of individual, organizational, and external level factors that influence the successful implementation of mHealth in different health systems and geographic contexts over time. Via the tool’s unique scoring system connected to qualitative descriptors, these data will inform the most critical implementation targets and contribute to the tailoring of strategies that will assist the health system in overcoming barriers to implementation, and ultimately, improve treatment adherence and engagement in care. Registered Report Identifier: RR1-10.2196/9633

  • Source: Hanscom Air Force Base (Mark Wyatt); Copyright: US Air Force; URL: http://www.hanscom.af.mil/News/Photos/igphoto/2000293073/; License: Public Domain (CC0).

    Therapeutic Management of Dyslipidemia Patients at Very High Cardiovascular Risk (CARDIO TRACK): Protocol for the Observational Registry Study

    Abstract:

    Background: Dyslipidemia is a major modifiable risk factor for atherosclerotic cardiovascular disease. Current South African guidelines recommend titrating lipid-lowering therapy (LLT) to low-density lipoprotein cholesterol (LDL-C) targets stratified by cardiovascular risk. The LDL-C goal for very high-risk patients is <1.8 mmol/L. In international studies, approximately 30% of patients do not achieve this goal despite receiving maximally tolerated statin doses. There is, however, a paucity of data on LDL-C goal achievement in very high-risk South African patients receiving maximal statin doses. Objective: The goal of the research it to assess LDL-C goal achievement in, and clinical characteristics of, very high cardiovascular risk dyslipidemic patients receiving maximal tolerated statin doses with or without ezetimibe. Methods: This is an observational, cross-sectional South African registry study that plans to include up to 30 sites and 500 study participants. Adult patients with very high cardiovascular risk status receiving stable, maximally tolerated statin doses (with or without ezetimibe) will be eligible for inclusion. Results: Funding has been awarded and enrollment began on November 15, 2017, and was completed on April 13, 2018, with 507 participants. Database lock was done on June 21, 2018. The statistical analysis has commenced and we expect the final clinical study report to be completed by October 2018. Conclusions: This study will document the adequacy of LLT in those at highest risk and will thus fill an important data gap in South Africa. This data may be useful in assessing the need for novel LLTs like proprotein convertase subtilisin/kexin 9 inhibitors that substantially lower cholesterol levels in addition to optimal statin therapy. Registered Report Identifier: RR1-10.2196/9248

  • The iShoppe virtual convenience store (montage). Source: The Authors / Placeit.net; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/7/e10468/; License: Creative Commons Attribution (CC-BY).

    Deception and Shopping Behavior Among Current Cigarette Smokers: A Web-Based, Randomized Virtual Shopping Experiment

    Abstract:

    Background: Virtual stores can be used to identify influences on consumer shopping behavior. Deception is one technique that may be used to attempt to increase the realism of virtual stores. Objective: The objective of the experiment was to test whether the purchasing behavior of participants in a virtual shopping task varied based on whether they were told that they would receive the products they selected in a virtual convenience store (a form of deception) or not. Methods: We recruited a US national sample of 402 adult current smokers by email from an online panel of survey participants. They completed a fully automated randomized virtual shopping experiment with a US $15 or US $20 budget in a Web-based virtual convenience store. We told a random half of participants that they would receive the products they chose in the virtual store or the cash equivalent (intervention condition), and the other random half simply to conduct a shopping task (control condition). We tested for differences in demographics, tobacco use behaviors, and in-store purchases (outcome variable, assessed by questionnaire) by experimental condition. Results: The characteristics of the participants (398/402, 99.0% with complete data) were comparable across conditions except that the intervention group contained slightly more female participants (103/197, 52.3%) than the control group (84/201, 41.8%; P=.04). We did not find any other significant differences in any other demographic variables or tobacco use, or in virtual store shopping behaviors, including purchasing any tobacco (P=.44); purchasing cigarettes (P=.16), e-cigarettes (P=.54), cigars (P=.98), or smokeless tobacco (P=.72); amount spent overall (P=.63) or on tobacco (P=.66); percentage of budget spent overall (P=.84) or on tobacco (P=.74); number of total items (P=.64) and tobacco items purchased (P=.54); or total time spent in the store (P=.07). Conclusions: We found that telling participants that they will receive the products they select in a virtual store did not influence their purchases. This finding suggests that deception may not affect consumer behavior and, as a result, may not be necessary in virtual shopping experiments.

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    Open Peer Review Period: Jul 17, 2018 - Jul 31, 2018

    Background: Youth account for a disproportionately high rates of new HIV infections in the United States (US). Despite intensive efforts to engage people living with HIV (PLWH) in the US, less than ha...

    Background: Youth account for a disproportionately high rates of new HIV infections in the United States (US). Despite intensive efforts to engage people living with HIV (PLWH) in the US, less than half of 13-24 years old achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV. Objective: There are three phases of this project. Phase 1 involves conducting focus groups in three cities (New York City, Chicago, and Houston) to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YouTHrive intervention among youth living with HIV (YLWH) in 6 US cities (Atlanta, New York City, Chicago, Houston, Philadelphia, and Tampa). Methods: In Phase 1, we will conduct six focus groups with approximately 8 youths (15-19 years old) and young adults (20-24 years old) each in three US cities to obtain: 1) feedback from YLWH about the “look and feel” and content of an existing adult-focused web-based ART adherence intervention; and 2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve collaboration with our technology development partner to update the existing intervention to include features and functionality recommended by YLWH in Phase 1. Phase 2 will conclude with beta testing with 12 participants to ensure that all features are working properly and function in a way that users can easily navigate. For Phase 3, we will enroll 300 YLWH in 6 US cities into a two-arm prospective randomized controlled trial (RCT). Participants randomized to the control condition will view a weekly newsletter for 20 weeks. The newsletter will be delivered via e-mail and will contain information on topics related to HIV, with the exception of ART adherence. Participants randomized to the YT intervention condition will be given access to the YT site for 20 weeks. Study assessments will occur at enrollment and 5, 8, and 11 months postenrollment. Results: Participant recruitment began in May 2017 for Phase 1 of the study. The data collection for Aim 3 is anticipated to end in April 2020. Conclusions: The efficacy trial of the YT intervention will help to fill gaps in understanding about the efficacy of mobile interventions to improve ART adherence among at-risk populations. Other important questions remain to be addressed, including how best to incorporate virtual ART interventions into clinical care and when they are most effectively delivered. Clinical Trial: ClinicalTrials.gov (NCT03149757); University of North Carolina at Chapel Hill Institutional Review Board (16-3136).

  • Using Targeted mHealth Messages to Address Hypertension and Diabetes Self-Management in Cambodia

    Date Submitted: Jul 17, 2018

    Open Peer Review Period: Jul 17, 2018 - Jul 31, 2018

    Background: Ischemic heart disease and stroke are now the two leading causes of mortality in Cambodia. While mobile health (mHealth) messaging programs have rapidly increased in low and middle income...

    Background: Ischemic heart disease and stroke are now the two leading causes of mortality in Cambodia. While mobile health (mHealth) messaging programs have rapidly increased in low and middle income countries (LMICs), adaptations for specific patient health needs is a new approach to manage chronic conditions. Objective: We are partnering with MoPoTsyo Patient Information Center in Phnom Penh to improve hypertension and diabetes self-management by implementing a combined eHealth and mHealth intervention. It is designed to enhance the communication network between providers and patients using electronic data capture (by tablet) and voice messages targeting individuals with specific health management needs. Methods: Community Peer Educators (PEs), who monitor patients’ health, have been randomized into three groups of 25 (approximately 60 patients each) to receive either (1) tablet + messages; (2) tablet only, or (3) no intervention (control). 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 completion of the intervention, clinical and process outcomes will be compared to baseline metrics between groups. Results: Results of the qualitative research were used to develop the telephone messages according to six themes: medications adherence, laboratory testing, physician visits (either annual or for alert determined at PE visit), obesity/weight gain, smoking, and general lifestyle issues (diet, exercise, salt intake, etc.). PEs were randomized in July 2017 and the intervention was implemented September 2017 through March 2018. Analyses are underway. Conclusions: This project is unique in its combining electronic data transfer which can be accessed immediately with voice messages most relevant to individual patients’ needs.

  • A phase II study evaluating the non-inferiority of a photodynamic therapy protocol involving the Flexitheralight device compared to the conventional protocol. (FLEXITHERALIGHT Study)

    Date Submitted: Jul 12, 2018

    Open Peer Review Period: Jul 13, 2018 - Jul 27, 2018

    Background: Actinic Keratosis (AK) are common pre-invasive cancerous lesions in sun-exposed skin, which negatively affect the quality of life in patients and may progress to invasive squamous cell car...

    Background: Actinic Keratosis (AK) are common pre-invasive cancerous lesions in sun-exposed skin, which negatively affect the quality of life in patients and may progress to invasive squamous cell carcinoma (SCC). Studies have shown that if untreated, AK may regress, or alternatively, may progress to SCC, with significant morbidity and possible lethal outcome. The most commonly used treatments for AK are cryotherapy, topical chemotherapy and, more recently, photodynamic therapy (PDT). This clinical study is part of a project, which aims at the creation of specific light emitting fabrics (LEF) in order to strongly improve the efficiency and reliability of PDT Objective: This study aims to compare the effectiveness and tolerability of a new PDT protocol involving the device Flexitheralight (N-PDT) versus the classical protocol involving the device Aktilite®128 (Galderma) (C-PDT) for the treatment of AK. All participants receive both protocols. The primary objective is to compare the lesion response rate at 3 months of N-PDT versus C-PDT. Secondary objectives are the evaluation of the pain and local tolerance during treatment, the clinical evolution of the subject's skin aspect, the quality of life and satisfaction of patients. Methods: The study is a split-face intra-individual comparison of two PDT protocols. The number of patients to be recruited is 42. Patients are exposed to a continuous red light spectrum with Aktilite®128 on one face, and, to a fractionated illumination with the new device Flexitheralight on the other face. Males or females over the age of 18 years with a clinical diagnosis of at least 10 previously untreated, non-pigmented, non-hyperkeratotic AK of Grade I and II of the forehead and/or scalp (according to Olsen et Al. JAAD 1991) are included in the department of dermatology of the Lille University Hospital. The patients come to the investigational center for one treatment session (Day 1) and they are followed at Day 7, Month 3 and Month 6. A second session of treatment can be performed at Day 111 in case of incomplete response at Month 3. Data are analysed using SAS software version 9.4 (SAS Institute Inc., Cary, North Carolina, USA). Continuous variables are expressed as the mean and standard deviation and categorical variables are expressed as the frequency and percentage. The Shapiro-Wilk test will be used to assess the normality of the distribution. Results: Investigations are achieved but data analysis is ongoing. The statistical results will be analyzed by the end of 2018 Conclusions: In case of non-inferior efficiency and better tolerability than C-PDT, N-PDT could become the treatment of choice for AK. Moreover, N-PDT is easy to implement in hospitals. Clinical Trial: N° ID-RCB 2013-A01096-39 Number Clinical Trial (NCT) NCT03076918 Protocol version 2.0 date 23.02.2015

  • Primary Prevention of Intimate Partner Violence among Recently-married Dyads Residing in Slums of Pune, India: Development and Rationale for a Dyadic Intervention

    Date Submitted: Jul 10, 2018

    Open Peer Review Period: Jul 12, 2018 - Jul 26, 2018

    Background: Intimate partner violence (IPV) is frequently experienced by women of low socio-economic status in India. It is a human rights violation and associated with negative effects on physical an...

    Background: Intimate partner violence (IPV) is frequently experienced by women of low socio-economic status in India. It is a human rights violation and associated with negative effects on physical and mental wellbeing, underscoring the need for effective prevention strategies. Objective: We aimed to develop a dyadic intervention for the primary prevention of IPV among newly-married couples residing in slum communities in India. Methods: The intervention was developed using a community-based, mixed-methods design, rooted in couple-interdependence theory and guided by the Intervention Mapping framework. It utilized the six critical intervention mapping steps to inform the content and delivery of the intervention: 1) a needs assessment, 2) preparation of matrices of change objectives, 3) selection of theory-based methods and practical applications, 4) production of intervention components and materials, 5) intervention adoption and implementation, and 6) evaluation planning. Results: The resulting “Ghya Bharari Ekatra” (“Take a Flight Together”) intervention is intended to be delivered in six weekly sessions by a trained pair of male and female lay community educators to groups of 3-5 newly-married couples in the community in which they reside. It uses games, discussions, self-reflections, and skill-building exercises to cover the following topics: enhancing relationship quality time, self-esteem and resilience, communication and conflict management, goal setting and implementation, sexual communication and sexual health and reproductive health knowledge, and redefining and challenging norms surrounding IPV occurrence. Ghya Bharari Ekatra was piloted between January and May 2018, and evaluation is presently underway. Conclusions: Ghya Bharari Ekatra is evidence-based, grounded in intervention-mapping, and developed and iteratively refined using a community-based participatory research approach, suggesting it has great potential to be an acceptable and effective solution to preventing IPV among newly married couples. Clinical Trial: ClinicalTrials.gov (NCT03332134) and the Clinical Trials Registry-India (CTRI/2018/01/011596)

  • Investigating Intervention Components and Exploring States of Receptivity for a Smartphone App to Promote Physical Activity: Study Protocol of the ALLY Micro-Randomized Trial

    Date Submitted: Jul 11, 2018

    Open Peer Review Period: Jul 12, 2018 - Jul 26, 2018

    Background: Smartphones enable the implementation of just-in-time adaptive interventions (JITAIs) that tailor the delivery of health interventions over time to user and time-varying context characteri...

    Background: Smartphones enable the implementation of just-in-time adaptive interventions (JITAIs) that tailor the delivery of health interventions over time to user and time-varying context characteristics. Ideally, JITAIs include effective intervention components and delivery tailoring is based on effective moderators of intervention effects. Using machine learning techniques to infer each user’s context from smartphone sensor data is a promising approach to further enhance tailoring. Objective: The primary objective is to quantify main effects, interactions and moderators of three intervention components of a smartphone-based intervention for physical activity. The secondary objective is the exploration of participants’ states of receptivity, i.e. situations in which participants are more likely to react to intervention notifications, through collection of smartphone sensor data. Methods: In 2017, we developed the Assistant to Lift your Level of activitY (Ally), a chatbot-based mHealth intervention for increasing physical activity that utilizes incentives, planning and self-monitoring prompts to help participants meet personalized step goals. We used a micro-randomized trial design to meet the study objectives. Insurees of large Swiss insurance company were invited to use the Ally app over a 12-day baseline and a six-week intervention period. Upon enrolment, participants were randomly allocated to either a financial incentive, a charity incentive or a no incentive condition. Over the course of the intervention period, participants were repeatedly randomized on a daily basis to either receive prompts that support self-monitoring or not, and on a weekly basis to receive one of two planning interventions or no planning. Participants completed a web-based questionnaire at baseline and post-intervention follow-up. Results: Data collection finished in January 2018. In total, 274 insurees enrolled in the study and installed the Ally app on their smartphones. Main reasons for declining participation were having an incompatible smartphone (20%) and collection of sensor data (19%). Step data is available for 227/274 participants (82.85%) and smartphone sensor data is available for 247/274 participants (90.15%). Conclusions: This study describes the evidence-based development of a JITAI for increasing physical activity. If components prove to be efficacious, they will be included in a revised version of the app that offers scalable promotion of physical activity at low cost. Clinical Trial: ClinicalTrials.gov NCT03384550

  • Diet-Induced Alteration of Microbiota and development of Obesity, Nonalcoholic fatty liver disease and Diabetes (DIAMOND): study protocol of a prospective study

    Date Submitted: Jul 11, 2018

    Open Peer Review Period: Jul 12, 2018 - Jul 26, 2018

    Background: Development of obesity and obesity related diseases such as type 2 diabetes mellitus and nonalcoholic fatty liver disease is associated with altered gut microbiota composition. The aim of...

    Background: Development of obesity and obesity related diseases such as type 2 diabetes mellitus and nonalcoholic fatty liver disease is associated with altered gut microbiota composition. The aim of this study is to investigate associations between dietary compounds, intestinal cell function and gut microbiota composition. We hypothesize that dietary lipid intake is associated with Paneth cell and goblet cell properties that affect gut microbiota composition. Objective: The goal of this study is to investigate associations between dietary compounds, intestinal cell function and gut microbiota composition Methods: This is a single-centre prospective study including one obese group undergoing laparoscopic roux-en-y gastric bypass and two lean control groups undergoing either laparoscopic cholecystectomy or upper gastrointestinal endoscopy (n=228). During laparoscopy, biopsies will be taken of visceral fat (omentum majus), liver, muscle tissue of the abdominal wall, and subcutaneous fat. In the obese group, a small segment of the jejunum will be collected for analysis, which will be compared with an endoscopically derived jejunal biopsy from the upper gastrointestinal endoscopy control group. Stool samples for microbiota profiling will be collected at baseline and one year after surgery. Primary outcomes are fecal microbiota composition, mucus characteristics, and Paneth cell phenotype. Secondary outcomes include body weight, diet composition, glucose tolerance and resolution of comorbidities. Results: Still undergoing recruitment Conclusions: The DIAMOND-study will improve insight into the pathophysiology of obesity and its associated metabolic disorders. Better understanding of weight loss failure and weight regain following bariatric surgery might also behold new therapeutic opportunities for obesity and obesity-related comorbidities. Clinical Trial: Nederlands Trial Register: NTR5660

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