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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:

  • Source: Pixabay; Copyright: zuzyusa; URL:; License: Public Domain (CC0).

    Examining the Effects of Mindful Eating Training on Adherence to a Carbohydrate-Restricted Diet in Patients With Type 2 Diabetes (the DELISH Study): Protocol...


    Background: Diet patterns have a profound influence on glycemic control for individuals with type 2 diabetes mellitus (T2DM), and craving-related eating is an important obstacle to dietary adherence. A growing body of research suggests that carbohydrate-restricted (CR) diets can improve glycemic control and reduce medication dependence in T2DM. However, limited data speak to the effects of long-term adherence to CR diets. Mindful eating training has been shown to reduce craving-related eating in overweight populations but has yet to be examined as a behavioral support for dietary adherence in T2DM. This trial examines behavioral mechanisms, particularly craving-related eating, through which mindful eating training might improve adherence to CR dietary recommendations in T2DM. This will clarify the importance of focusing on craving-related eating in the optimization of dietary adherence interventions. Objective: The aim of this trial is to determine whether providing training in mindful eating increases adherence to a CR dietary recommendation in T2DM. Methods: We are randomizing 60 participants to receive a CR diet with or without mindful eating training (12-week group intervention) and are following participants for 12 weeks after intervention completion. We hypothesize that participants who receive mindful eating training (relative to those who do not) will demonstrate greater adherence to the CR diet. Results: Our primary outcome is change in craving-related eating, as assessed using an ecological momentary assessment mobile phone–based platform. Secondary behavioral pathway outcomes include changes in stress-related eating, impulsivity, glycemic control, weight change, dietary adherence, and resumption of dietary adherence after dietary nonadherence. Conclusions: This theory-driven trial will shed light on the impact of mindfulness training on mechanisms that may impact dietary adherence in T2DM. Trial Registration: NCT03207711; (Archived by WebCite at  International Registered Report Identifier (IRRID): DERR1-10.2196/11002

  • Source: The Authors / Placeit; Copyright: JMIR Publications; URL:; License: Creative Commons Attribution (CC-BY).

    Pilot Testing the Feasibility of a Game Intervention Aimed at Improving Help Seeking and Coping Among Sexual and Gender Minority Youth: Protocol for a...


    Background: Sexual and gender minority youth (SGMY; eg, lesbian, gay, bisexual, and transgender youth) experience myriad substance use and mental health disparities compared with their cisgender (nontransgender) heterosexual peers. Despite much research showing these disparities are driven by experiences of bullying and cyberbullying victimization, few interventions have aimed to improve the health of bullied SGMY. One possible way to improve the health of bullied SGMY is via a Web-accessible game intervention. Nevertheless, little research has examined the feasibility of using a Web-accessible game intervention with SGMY. Objective: This study aimed to describe the protocol for a randomized controlled trial (RCT) pilot, testing the feasibility and limited efficacy of a game-based intervention for increasing help-seeking–related knowledge, intentions, self-efficacy, behaviors, productive coping skills use, and coping flexibility and reducing health risk factors and behaviors among SGMY. Methods: We enrolled 240 SGMY aged 14 to 18 years residing in the United States into a 2-arm prospective RCT. The intervention is a theory-based, community-informed, computer-based, role playing game with 3 primary components: encouraging help-seeking behaviors, encouraging use of productive coping, and raising awareness of Web-based resources. SGMY randomized to both the intervention and control conditions will receive a list of SGMY-inclusive resources, covering a variety of health-related topics. Control condition participants received only the list of resources. Notably, all study procedures are conducted via the internet. We conveniently sampled SGMY using Web-based advertisements. Study assessments occur at enrollment, 1 month after enrollment, and 2 months after enrollment. The primary outcomes of this feasibility study include implementation procedures, game demand, and game acceptability. Secondary outcomes include help-seeking intentions, self-efficacy, and behaviors; productive coping strategies and coping flexibility; and knowledge and use of Web-based resources. Tertiary outcomes include bullying and cyberbullying victimization, loneliness, mental health issues, substance use, and internalized sexual and gender minority stigma. Results: From April to July 2018, 240 participants were enrolled and randomized. Half of the enrolled participants (n=120) were randomized into the intervention condition and half (n=120) into the control condition. At baseline, 52.1% (125/240) of the participants identified as gay or lesbian, 26.7% (64/240) as bisexual, 24.2% (58/240) as queer, and 11.7% (28/240) as another nonheterosexual identity. Nearly half (113/240) of participants were a gender minority: 36.7% (88/240) were cisgender boys, and 16.3% (39/240) were cisgender girls. There were no differences in demographic characteristics between intervention and control condition participants. Conclusions: Web-accessible game interventions overcome common impediments of face-to-face interventions and present a unique opportunity to reach SGMY and improve their health. This trial will provide data on feasibility and limited efficacy that can inform future Web-based studies and a larger RCT aimed at improving health equity for SGMY. Trial Registration: NCT03501264; (Archived by WebCite at International Registered Report Identifier (IRRID): DERR1-10.2196/12164

  • Source: Image created by the Authors; Copyright: The Authors; URL:; License: Public Domain (CC0).

    Discussing Weight Management With Type 2 Diabetes Patients in Primary Care Using the Small Talk Big Difference Intervention: Protocol for a Randomized...


    Background: Guidelines for the management of type 2 diabetes universally recommend that adults with type 2 diabetes and obesity be offered individualized interventions to encourage weight loss. Yet despite the existing recommendations, provision of weight management services is currently patchy around the United Kingdom and where services are available, high attrition rates are often reported. In addition, individuals often fail to take up services, that is, after discussion with a general practitioner or practice nurse, individuals are referred to the service but do not attend for an appointment. Qualitative research has identified that the initial discussion raising the issue of weight, motivating the patient, and referring to services is crucial to a successful outcome from weight management. Objective: Our aim was to evaluate the effectiveness of an Internet-based training program and practice implementation toolkit with or without face-to-face training for primary care staff. The primary outcome is the change in referral rate of patients with type 2 diabetes to National Health Service adult weight management programs, 3 months pre- and postintervention. Methods: We used the Behavior Change Wheel to develop an intervention for staff in primary care consisting of a 1-hour Internet-based eLearning package covering the links between obesity, type 2 diabetes, and the benefits of weight management, the treatment of diabetes in patients with obesity, specific training in raising the issue of weight, local services and referral pathways, overview of weight management components/ evidence base, and the role of the referrer. The package also includes a patient pamphlet, a discussion tool, a practice implementation checklist, and an optional 2.5-hour face-to-face training session. We have randomly assigned 100 practices in a 1:1 ratio to either have immediate access to all the resources or have access delayed for 4 months. An intention-to-treat statistical analysis will be performed. Results: Recruitment to the study is now complete. We will finalize follow-up in 2018 and publish in early 2019. Conclusions: This protocol describes the development and randomized evaluation of the effectiveness of an intervention to improve referral and uptake rates of weight management programs for adults with type 2 diabetes. At a time when many new dietary and pharmacological weight management interventions are showing large clinical benefits for people with type 2 diabetes, it is vital that primary care practitioners are willing, skilled, and able to discuss weight and make appropriate referrals to services. Trial Registration: NCT03360058; (Archived by WebCite at International Registered Report Identifier (IRRID): RR1-10.2196/12162

  • Source: The US National Archives; Copyright: Department of Defense; URL:; License: Public Domain (CC0).

    Determining Best Practices for Management of Bacteriuria in Spinal Cord Injury: Protocol for a Mixed-Methods Study


    Background: Bacteriuria, either asymptomatic (ASB) or symptomatic, urinary tract infection (UTI), is common in persons with spinal cord injury (SCI). Current Veterans Health Administration (VHA) guidelines recommend a screening urinalysis and urine culture for every veteran with SCI during annual evaluation, even when asymptomatic, which is contrary to other national guidelines. Our preliminary data suggest that a positive urine culture (even without signs or symptoms of infection) drives antibiotic use. Objective: Through a series of innovative studies utilizing mixed methods, administrative databases, and focus groups, we will gain further knowledge about the attitudes driving current urine testing practices during the annual exam, as well as quantitative data on the clinical outcomes of these practices. Methods: Aim 1 will identify patient, provider, and facility factors driving bacteriuria testing and subsequent antibiotic use after the SCI annual evaluation through qualitative interviews and quantitative surveys. Aim 2 will use national VHA databases to identify the predictors of urine testing and subsequent antibiotic use during the annual examination and compare the clinical outcomes of those who received antibiotics with those who did not. Aim 3 will use the information gathered from the previous 2 aims to develop the Test Smart, Treat Smart intervention, a combination of patient and provider education and resources that will help stakeholders have informed conversations about urine testing and antibiotic use; feasibility will be tested at a single site. Results: This protocol received institutional review board and VHA Research and Development approval in July 2017, and Veterans Affairs Health Services Research and Development funding started on November 2017. As of submission of this manuscript, 10/15 (67%) of the target goal of provider interviews were complete, and 77/100 (77%) of the goal of surveys. With regard to patients, 5/15 (33%) of the target goal of interviews were complete, and 20/100 (20%) of the target goal of surveys had been completed. Preliminary analyses are ongoing; the study team plans to present these results in April 2019. Database analyses for aim 2 will begin in January 2019. Conclusions: The negative consequences of antibiotic overuse and antibiotic resistance are well-documented and have national and even global implications. This study will develop an intervention aimed to educate stakeholders on evidence-based management of ASB and UTI and guide antibiotic stewardship in this high-risk population. The next step will be to refine the intervention and test its feasibility and effectiveness at multiple sites as well as reform policy for management of this common but burdensome condition. International Registered Report Identifier (IRRID): DERR1-10.2196/12272

  • Source: Freepik; Copyright: mindandi; URL:; License: Licensed by JMIR.

    Transforming Mental Health Delivery Through Behavioral Economics and Implementation Science: Protocol for Three Exploratory Projects


    Background: Efficacious psychiatric treatments are not consistently deployed in community practice, and clinical outcomes are attenuated compared with those achieved in clinical trials. A major focus for mental health services research is to develop effective and cost-effective strategies that increase the use of evidence-based assessment, prevention, and treatment approaches in community settings. Objective: The goal of this program of research is to apply insights from behavioral economics and participatory design to advance the science and practice of implementing evidence-based practice (EBP) for individuals with psychiatric disorders across the life span. Methods: Project 1 (Assisting Depressed Adults in Primary care Treatment [ADAPT]) is patient-focused and leverages decision-making heuristics to compare ways to incentivize adherence to antidepressant medications in the first 6 weeks of treatment among adults newly diagnosed with depression. Project 2 (App for Strengthening Services In Specialized Therapeutic Support [ASSISTS]) is provider-focused and utilizes normative pressure and social status to increase data collection among community mental health workers treating children with autism. Project 3 (Motivating Outpatient Therapists to Implement: Valuing a Team Effort [MOTIVATE]) explores how participatory design can be used to design organizational-level implementation strategies to increase clinician use of EBPs. The projects are supported by a Methods Core that provides expertise in implementation science, behavioral economics, participatory design, measurement, and associated statistical approaches. Results: Enrollment for project ADAPT started in 2018; results are expected in 2020. Enrollment for project ASSISTS will begin in 2019; results are expected in 2021. Enrollment for project MOTIVATE started in 2018; results are expected in 2019. Data collection had begun for ADAPT and MOTIVATE when this protocol was submitted. Conclusions: This research will advance the science of implementation through efforts to improve implementation strategy design, measurement, and statistical methods. First, we will test and refine approaches to collaboratively design implementation strategies with stakeholders (eg, discrete choice experiments and innovation tournaments). Second, we will refine the measurement of mechanisms related to heuristics used in decision making. Third, we will develop new ways to test mechanisms in multilevel implementation trials. This trifecta, coupled with findings from our 3 exploratory projects, will lead to improvements in our knowledge of what causes successful implementation, what variables moderate and mediate the effects of those causal factors, and how best to leverage this knowledge to increase the quality of care for people with psychiatric disorders. Trial Registration: NCT03441399; (Archived by WebCite at International Registered Report Identifier (IRRID): DERR1-10.2196/12121

  • Source: Flickr; Copyright: Juan Salmoral; URL:; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized...


    Background: Smoking cessation treatment programs have been widely available for patients with nicotine dependence. Despite intensive programs, the continuous abstinence rate (CAR) from weeks 9-12 is still about 50%. Recently, a smartphone app emerged as a novel tool for therapeutic interventions, including nicotine dependence. In this study, we developed “CureApp Smoking Cessation” (CASC), which consists of a smartphone app for patients and a Web-based patient management software for doctors with a mobile carbon monoxide (CO) checking device to improve the efficacy of the smoking cessation treatment. Objective: This study aims to evaluate whether the CASC app is effective for individuals with nicotine dependence in addition to standard smoking cessation programs. Methods: This will be a randomized, sham-controlled, open-label, multicenter trial. We will recruit participants with nicotine dependence, but are otherwise healthy adults. We will randomize and allocate participants 1:1 to the CASC treatment group or a control app group. Both groups will receive a 12-week standard smoking cessation program with pharmacotherapy and counseling. In addition, participants in the treatment group will have the CASC app installed on their smartphone, which will provide video tutorials, advice from an artificial intelligence nurse, a digital diary, and measure daily exhaled CO concentration. In contrast, the control group will have the control app installed on their smartphone, where all the functions that can potentially effect smoking cessation are removed. The primary outcome will be the biochemically validated CAR from weeks 9-24. The success of smoking cessation will be defined as self-reported continuous abstinence from weeks 9-24 and exhaled CO concentration ≤10 ppm both at weeks 12 and 24. The main secondary outcomes will be the CAR from weeks 9-12, weeks 9-52, and 7-day point prevalence abstinence at weeks 4, 8, 12, 24, and 52. Results: We will recruit 580 participants with nicotine dependence from October 2017 to September 2018 or until the recruitment process is complete. The final 52-week follow-up will be completed in October 2019. We expect all trial results to be available by the end of 2019. The trial is funded by CureApp, Inc. Conclusions: This is the first randomized controlled trial to evaluate the efficacy of CASC. We expect that CASC, in addition to standard smoking cessation programs, has a significantly higher CAR during weeks 9-24 than the control app. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000031589; International Registered Report Identifier (IRRID): DERR1-10.2196/12252

  • Source: Flickr; Copyright: EdTech Stanford University School of Medicine; URL:; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Blockchain Implementation in Health Care: Protocol for a Systematic Review


    Background: A blockchain is a digitized, decentralized, distributed public ledger that acts as a shared and synchronized database that records cryptocurrency transactions. Despite the shift toward digital platforms enabled by electronic medical records, demonstrating a will to reform the health care sector, health systems face issues including security, interoperability, data fragmentation, timely access to patient data, and silos. The application of health care blockchains could enable data interoperability, enhancement of precision medicine, and reduction in prescription frauds through implementing novel methods in access and patient consent. Objective: To summarize the evidence on the strategies and frameworks utilized to implement blockchains for patient data in health care to ensure privacy and improve interoperability and scalability. It is anticipated this review will assist in the development of recommendations that will assist key stakeholders in health care blockchain implementation, and we predict that the evidence generated will challenge the health care status quo, moving away from more traditional approaches and facilitating decision making of patients, health care providers, and researchers. Methods: A systematic search of MEDLINE/PubMed, Embase, Scopus, ProQuest Technology Collection and Engineering Index will be conducted. Two experienced independent reviewers will conduct titles and abstract screening followed by full-text reading to determine study eligibility. Data will then be extracted onto data extraction forms before using the Cochrane Collaboration Risk of Bias Tool to appraise the quality of included randomized studies and the Risk of Bias in nonrandomized studies of Interventions to assess the quality of nonrandomized studies. Data will then be analyzed and synthesized. Results: Database searches will be initiated in September 2018. We expect to complete the review in January 2019. Conclusions: This review will summarize the strategies and frameworks used to implement blockchains in health care to increase data privacy, interoperability, and scalability. This review will also help clarify if the strategies and frameworks required for the operationalization of blockchains in health care ensure the privacy of patient data while enabling efficiency, interoperability, and scalability.

  • Source: Flickr; Copyright: World Bank Photo Collection; URL:; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Digital Technology in Somatic and Gene Therapy Trials of Pediatric Patients With Ocular Diseases: Protocol for a Scoping Review


    Background: Pharmacogenomics suggests that diseases with similar symptomatic presentations often have varying genetic causes, affecting an individual patient’s response to a specific therapeutic strategy. Gene therapies and somatic cell therapies offer unique therapeutic pathways for ocular diseases and often depend on increased understanding of the genotype-phenotype relationship in disease presentation and progression. While demand for personalized medicine is increasing and the required molecular tools are available, its adoption within pediatric ophthalmology remains to be maximized in the postgenomic era. Objective: The objective of our study was to address the individual hurdles encountered in the field of genomic-related clinical trials and facilitate the uptake of personalized medicine, we propose to conduct a review that will examine and identify the digital technologies used to facilitate data analysis in somatic and gene therapy trials in pediatric patients with ocular diseases. Methods: This paper aims to present an outline for Healthcare Information Technology and Information and Communication Technology resources used in somatic and gene therapy clinical trials in children with ocular diseases. This review will enable authors to identify challenges and provide recommendations, facilitating the uptake of genetic and somatic therapies as therapeutic tools in pediatric ophthalmology. The review will also determine whether conducting a systematic review will be beneficial. Results: Database searches will be initiated in September 2018. We expect to complete the review in December 2019. Conclusions: Based on review findings, the authors will summarize methods used for facilitating IT integration in personalized medicine. Additionally, it will identify further research gaps and determine whether conducting further reviews will be beneficial. International Registered Report Identifier (IRRID): PRR1-10.2196/10705

  • Source: CANuVENT; Copyright: CANuVENT; URL:; License: Licensed by the authors.

    Development of a Web-Based Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals Living in the Community: Protocol for a Pilot...


    Background: Across Europe, Canada, Australia, and the United States, the prevalence of home mechanical ventilation (HMV) prevalence is 6.6-12.9 per 100,000. At-home ventilator-assisted individuals (VAIs) are often vulnerable and highly comorbid, requiring complex care. In Canada, most VAI care is provided by family, leading to poor health-related quality of life and increased caregiver burden. No supportive interventions or peer support programs are tailored to VAI caregivers. Owing to the financial, geographic, and time limitations, Web-based support delivery may especially meet VAI family caregiver needs. We have developed a peer mentor training and Web-based peer support program for VAI caregivers including information-sharing, peer-to-peer communication, and peer mentorship. Objective: Study Stage 1 aims to (1) evaluate the face and content validity of the peer mentor training program and (2) investigate participant satisfaction. Study Stage 2 aims to evaluate (1) the feasibility of participant recruitment and Web-based program delivery; (2) acceptability, usability, and satisfactoriness; (3) experiences of caregivers and peer mentors with the Web-based peer support program; and (4) effect of the Web-based peer support program on caregiver health outcomes. Methods: Study Stage 1: We will train 7 caregivers to act as peer mentors for the Web-based peer support program trial; they will complete questionnaires rating the utility of individual training sessions and the training program overall. Study Stage 2: We will recruit 30 caregiver peers for a pilot randomized controlled trial of the 12-week Web-based peer support program using a waitlist control; the program includes private chat, a public discussion forum, and weekly moderated chats. Caregiver peers will be randomized to the intervention or waitlist control group using a 1:1 ratio using Both groups will complete pre- and postintervention health outcome questionnaires (ie, caregiving impact, mastery, coping, personal gain, positive affect, and depression). Caregiver peers in the intervention arm will only complete a program evaluation and will be invited to participate in an interview to provide insight into their experience. Peer mentors will be invited to participate in a Web-based focus group to provide insight into their experience as mentors. We will judge the feasibility per the number of recruitment and program delivery goals met, use analysis of covariance to compare health outcomes between intervention and control groups, and analyze qualitative data thematically. Results: Peer mentor training was completed with 5 caregivers in July 2018. To date, 2 caregivers have beta-tested the website, and the Web-based peer support program trial will commence in September 2018. Results are expected by early 2019. Conclusions: This study will result in the production and initial evaluation of a rigorously developed, evidence- and stakeholder-informed Web-based peer training and peer support program for caregivers of VAIs residing at home. International Registered Report Identifier (IRRID): PRR1-10.2196/11827

  • Source: The Authors; Copyright: The Authors; URL:; License: Public Domain (CC0).

    The Safety, Tolerability, and Effects on the Systemic Inflammatory Response and Renal Function of the Human Chorionic Gonadotropin Hormone-Derivative EA-230...


    Background: The cardiac surgery–induced systemic inflammatory response may induce postoperative hemodynamic instability and impairment of renal function. EA-230, a linear tetrapeptide (A-Q-G-V), is derived from the beta chain of the human chorionic gonadotropin pregnancy hormone. It has shown immunomodulatory and renoprotective effects in several animal models of systemic inflammation. In phase 1 and phase 2a studies, these immunomodulatory effects were confirmed during human experimental endotoxemia, and EA-230 was found to have an excellent safety profile. Objective: The objective of this first in-patient study is to test the safety and tolerability as well as the immunomodulatory and renoprotective effects of EA-230 in a proof-of-principle design in patients with systemic inflammation following on-pump cardiac surgery. Methods: We describe a prospective, randomized, double-blind, placebo-controlled study in which 180 elective patients undergoing on-pump coronary artery bypass grafting, with or without concomitant valve surgery, are enrolled. Patients will be randomized in a 1:1 ratio and will receive either EA-230 (90 mg/kg/hour) or a placebo. These will be infused at the start of the surgical procedure until the end of the use of the cardiopulmonary bypass. The primary focus of this first-in-patient study will be on safety and tolerability of EA-230. The primary efficacy end point is the modulation of the inflammatory response by EA-230 quantified as the change in interleukin-6 plasma concentrations after surgery. The key secondary end point is the effect of EA-230 on renal function. The study will be conducted in 2 parts to enable an interim safety analysis by an independent data monitoring committee at a sample size of 60. An adaptive design is used to reassess statistical power halfway through the study. Results: This study has been approved by the independent competent authority and ethics committee and will be conducted in accordance with the ethical principles of the Declaration of Helsinki, guidelines of Good Clinical Practice, and European Directive 2001/20/CE regarding the conduct of clinical trials. Results of this study will be submitted for publication in a peer-reviewed scientific journal. Enrollment of this study commenced in July 2016, and results are expected at the end of 2018. Conclusions: This adaptive phase 2 clinical study is designed to test the safety and tolerability of EA-230 in patients undergoing cardiac surgery. In addition, efficacy end points focused on the effect of the systemic inflammatory response and renal function are investigated. Trial Registration: NCT03145220; (Archived by WebCite at International Registered Report Identifier (IRRID): DERR1-10.2196/11441

  • Source: Pixabay; Copyright: misign; URL:; License: Licensed by JMIR.

    Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP): Protocol for a Feasibility and Exploratory Efficacy Study in Men on Androgen...


    Background: Androgen deprivation therapy (ADT) for prostate cancer is associated with adverse cardiometabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction, and stroke. This reduces quality of life and potentially increases mortality. Several large clinical trials have demonstrated improvements in cardiometabolic risk with comprehensive multimodality lifestyle modification. However, there is a lack of data for such interventions in men on ADT for prostate cancer, and existing studies have used non-standardized interventions or lacked data on metabolic risk factors. Objective: The Comprehensive Lifestyle Improvement Project for Prostate Cancer (CLIPP) is designed to address these gaps by using an intervention modeled on the Diabetes Prevention Program, a standardized multicomponent intervention with demonstrated effectiveness in reducing cardiometabolic risk factors that has been successfully adapted for multiple disease types including breast cancer. Methods: A single-arm unblinded clinical trial will be conducted to determine the feasibility of conducting a 24-week comprehensive lifestyle modification intervention that targets weight loss and increased physical activity modeled on the Diabetes Prevention Program in 30 men on ADT for prostate cancer. Secondary aims are to determine the effect of the intervention on cardiometabolic markers and quality of life. The tertiary aim is to determine the effect of the intervention on markers of inflammation and angiogenesis, important mechanisms for prostate cancer progression. Participants will be recruited from the University of Arizona Cancer Center and the surrounding community. The intervention will be delivered weekly in person and over the phone for 16 weeks. For Weeks 16-24, participants receive weekly phone calls from the study health coach to motivate them to continue their lifestyle modification. Questionnaire and biological data are collected at baseline, 12 weeks, and 24 weeks. Body composition using dual-energy x-ray absorptiometry scans will be performed at baseline and end of study. Results: Based on a sample size of 30, the two-sided 95% confidence interval will not be wider than 0.373 standard deviations for the adherence rate and will not be wider than 0.374 for the retention rate. In addition, the study will have a power of 80% to detect a change of 0.47 standard deviations from baseline for each of the markers investigated in the secondary and tertiary aims assuming a within-subject correlation of 0.20 at a significance level of 5%. The recruitment period is from October 2018 to April 2019. Conclusions: The aim of CLIPP is to determine the feasibility of conducting a Diabetes Prevention Program–style comprehensive lifestyle modification intervention in men with ADT for prostate cancer and its effects on cardiometabolic adverse effects, quality of life, as well as markers of inflammation and angiogenesis. Results will inform the development of future clinical trials in this population. International Registered Report Identifier (IRRID): DERR1-10.2196/12579

  • Source: Pexels; Copyright: ELEVATE; URL:; License: Licensed by JMIR.

    Rationale and Design of a Remote Web-Based Daily Diary Study Examining Sexual Minority Stress, Relationship Factors, and Alcohol Use in Same-Sex Female...


    Background: The Healthy People 2020 initiative aims to reduce health disparities, including alcohol use, among sexual minority women (SMW; eg, lesbian, bisexual, queer, and pansexual). Compared with heterosexual women, SMW engage in more hazardous drinking and report more alcohol-related problems. Sexual minority stress (ie, the unique experiences associated with stigmatization and marginalization) has been associated with alcohol use among SMW. Among heterosexuals, relationship factors (eg, partner violence and drinking apart vs together) have also been associated with alcohol use. Negative affect has also been identified as a contributor to alcohol use. To date, most studies examining alcohol use among SMW have used cross-sectional or longitudinal designs. Objective: Project Relate was designed to increase our understanding of alcohol use among young SMW who are at risk for alcohol problems. The primary objectives of this study are to identify daily factors, as well as potential person-level risk and protective factors, which may contribute to alcohol use in SMW. Secondary objectives include examining other physical and mental concerns in this sample (eg, other substance use, eating, physical activity, and stress). Methods: Both partners of a female same-sex couple (aged 18-35 years; n=150 couples) are being enrolled in the study following preliminary screening by a market research firm that specializes in recruiting sexual minority individuals. Web-based surveys are being used to collect information about the primary constructs of interest (daily experiences of alcohol use, sexual minority stress, relationship interactions, and mood) as well as secondary measures of other physical and mental health constructs. Data are collected entirely remotely from women across the United States. Each member of eligible couples completes a baseline survey and then 14 days of daily surveys each morning. Data will be analyzed using multilevel structural equation modeling. Results: To date, 208 women (ie, 104 couples) were successfully screened and enrolled into the study. In total, 164 women have completed the 14-day daily protocol. Compliance with completing the daily diaries has been excellent, with participants on average completing 92% of the daily diaries. Data collection will be completed in fall 2018, with results published as early as 2019 or 2020. Conclusions: Project Relate is designed to increase our understanding of between- and within-person processes underlying hazardous drinking in understudied, at-risk SMW. The study includes a remote daily diary methodology to provide insight into variables that may be associated with daily hazardous alcohol use. Before the development of programs that address hazardous alcohol use among young SMW, there is a need for better understanding of individual and dyadic variables that contribute to risk in this population. The unique challenges of recruiting and enrolling SMW from across the United States in a daily diary study are discussed. International Registered Report Identifier (IRRID): DERR1-10.2196/11718

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    Open Peer Review Period: Feb 19, 2019 - Mar 5, 2019

    Background: Population aging has major social and economic consequences. Although many older people can support themselves and continue to make important contributions to society, the burden of diseas...

    Background: Population aging has major social and economic consequences. Although many older people can support themselves and continue to make important contributions to society, the burden of disease and disability increases with age. One condition that affects older people is dementia. Even in the early stages it can be burdensome for those affected as well as their relatives. Technology to support the day-to-day living activities at home for people with cognitive impairments have been developed during the last years. Most products focus on single problem solution and few are integrated into a single product. The impact of these devices is seldom studied in other ways than through feasibility studies. Randomized controlled studies (RCT) investigating the effect or effectiveness of these products are sparse. Objective: We aim to test the influence on Quality of Life (QoL) of persons with mild cognitive impairment (PwMCI) and carers who use a digital platform (SMART4MD). Also studied are influence on medication adherence, cognitive impairment, functional decline, service utilization and economic analysis. Methods: A pragmatic, multicenter RCT following the CONSORT guidelines is performed in Spain, Sweden and Belgium: Consorci Sanitari de Terrassa (Catalonia, Spain), Servicio Andaluz de Salud (Andalusia, Spain), Blekinge Institute of Technology (Sweden) and University Colleges Leuven-Limburg (Belgium). 1200 dyads is the target for recruitment: an intervention group and a control group whom are in usual care. Intervention group participants will be provided with a data-enabled computer tablet with the SMART4MD application (a general e-health application adapted specifically for mild cognitive impairment). Its core functionalities, intended to be used daily at home, are based on reminders, cognitive supporting activities and sharing health information. Results: Inclusion of participants started in December 2017 and recruitment is expected to end in February 2019. Three follow-up visits at 6, 12 and 18 months after the baseline visit. Conclusions: The benefits of this RCT will be at several levels including in-depth knowledge of the possibilities of introducing a holistic multilayered ICT solution for this particular group. SMART4MD has been developed in a process involving the structured participation of PwMCI, their informal carers, and clinicians. The adoption of SMART4MD faces the challenge of this age group’s relative unfamiliarity with digital devices and services. However, this challenge can also be an opportunity for developing a digital device tailored to a group at risk of digital exclusion. This research responds to the wider call for the development of digital devices which are accessible and affordable to older people, rather than a source of anxiety. Since effect and effectiveness studies of e-health related products are demanded, results and experiences from this full scale RCT can hopefully serve as a model for further studies in this field. Clinical Trial: Identifier: NCT03325699.

  • Analysing healthcare impact: monitoring immobilised elderly patients using SIRUPP, an online system for pressure ulcer information and registration used by healthcare professionals in Granada (Spain).

    Date Submitted: Feb 15, 2019

    Open Peer Review Period: Feb 19, 2019 - Mar 5, 2019

    Background: Pressure ulcers (PUs) represent a major challenge to patient safety in healthcare contexts, presenting high incidence and increased financial costs in medical treatment. Moreover, they are...

    Background: Pressure ulcers (PUs) represent a major challenge to patient safety in healthcare contexts, presenting high incidence and increased financial costs in medical treatment. Moreover, they are a significant predictor of mortality. The prevention of PUs in long-term care centres and in patients’ own homes is proposed as a priority indicator of healthcare quality. Early-stage risk assessment and database recording are both crucial aspects of prevention, classification, diagnosis and treatment. Objective: The project proposes a three-year study of immobilised patients residing in the Granada-Metropolitan Primary Healthcare District (GM-PHCD) and monitored via the Pressure Ulcer Information and Registration System (SIRUPP, Spanish initials). The project aims to: 1) estimate the incidence of PUs among immobilised elderly patients; 2) analyse the health-related quality of life of these patients, by means of the Pressure Ulcer Quality of Life instrument (PU-QoL); 3) determine the average time to complete wound healing; 4) determine rate of PU-associated mortality; and 5) assess the predictive value of the Braden and Mini Nutritional Assessment risk measurement scales. Methods: The GM-PHCD runs SIRUPP, which is linked to patients’ electronic health records. Currently, 17,104 immobilised patients are monitored under this system. Health-related quality of life will be measured by patient self-reports using the Spanish Pressure Ulcer Quality of Life questionnaire, following cross-cultural adaptation and psychometric validation with respect to the English-language version. Results: The project commenced in June 2017 and is expected to conclude in April 2020. Conclusions: This study addresses two main health outcomes: the time needed for wound healing and the mortality associated with PUs, both of which might be accounted for by variations in clinical practice; and the health-related quality of life of patients with PUs.

  • Child Immunization App (CImA) study – A research protocol for a non-blinded randomized controlled pilot trial intervention study among Syrian refugees in Zaatari camp, Jordan

    Date Submitted: Jan 30, 2019

    Open Peer Review Period: Feb 19, 2019 - Mar 5, 2019

    Child immunization is a key component of the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF)’s child survival intervention package. Yet, internationally, there are...

    Child immunization is a key component of the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF)’s child survival intervention package. Yet, internationally, there are up to 19.4 million children who are still unvaccinated, and face unnecessary deaths, especially among refugees. Growing access to smartphones, among refugees, was a leading factor to use this technology to improve vaccination rate. This study aims to determine whether a smartphone application (app) can improve the vaccination uptake among refugees and determine the app effectiveness in improving the documentation of vaccination records among parents. We developed and planned to test an app through a randomized trial that will be carried out at the Zaatari refugees camp in Jordan. The study will be open to all parents that carry Android smartphone phones, have at least one child and agree to participate in the study. The parents will be recruited to the study by trained volunteers at the seven local clinics, providing vaccinations, around the Zaatari camp. Inclusion criteria will be: having at least one child age 0-5 years of age, being a local resident of the camp and having an Android smartphone that can allow CImA app installation. The intervention includes an app that will allow storing Jordanian vaccination records, per child, on the parents’ smartphones in Arabic and in English languages (in an interchangeable fashion). Every record will have a set of automated reminders prior the appointment of each child. The app will summarize immunization records in form of “due”, “taken” or “overdue” appointments, labeled in orange, green and red respectively. Baseline will include the collection of our primary and secondary outcomes that are needed for the pre- and post-data measurements. This includes social demographic data, any prior vaccine history and eHealth literacy. Participants, in both study arms, will be monitored for their follow-up visits to the clinic for the vaccination doses. For the study outcome measures, we will measure any differences in the uptake of vaccinations. The secondary outcome is to analyze the effect of the CImA app on visits for the follow-up doses. Due to the limited evidence of effective interventions for childhood vaccination among refugees, research in this area is in great need. The project will have a significant impact on the health of refugees and the public health system. In Jordan, and the Middle East, the vaccination level is low. Given the influx of refugees from the area it is crucial to ensure a high vaccination level for the refugees, especially for children, to avoid VPDs.

  • Social Support and Common Dyadic Coping in Couple’s Dyadic Management of Type II Diabetes: Study Protocol for an Ambulatory Assessment Application

    Date Submitted: Feb 12, 2019

    Open Peer Review Period: Feb 15, 2019 - Mar 1, 2019

    Diabetes mellitus Type II (T2DM) is a common chronic disease. To manage blood glucose levels patients need to follow medical recommendations for healthy eating, physical activity, and medication adher...

    Diabetes mellitus Type II (T2DM) is a common chronic disease. To manage blood glucose levels patients need to follow medical recommendations for healthy eating, physical activity, and medication adherence in their everyday life. Illness management is mainly shared with partners and involves social support and common dyadic coping (CDC). Social support and CDC have been identified as having implications for people’s health behavior and well-being. Visible support, however, may also be negatively related to people’s well-being. Thus, the concept of invisible support was introduced. It is unknown which of these concepts (visible support, invisible support, CDC) displays the most beneficial associations with health behavior and well-being when considered together in the context of illness management in couple’s everyday life. Therefore, a novel ambulatory assessment application for the open source behavioral intervention platform MobileCoach (AAMC) was developed. It utilizes objective sensor data in combination with self-reports in couple’s everyday life. This study protocol describes the design of the Dyadic Management of Diabetes (DyMand) study, funded by the Swiss National Science Foundation (CR12I1_166348/1). The study was approved by the cantonal ethics committee of the Canton of Zurich, Switzerland (Req-2017_00430). This study follows an intensive longitudinal design with two phases of data collection. The first phase is a naturalistic observation phase of couple’s conversations in combination with an experience sampling phase in daily life of N = 180 T2DM patients and their romantic partners using sensor data from smartwatches, mobile phones and accelerometers for seven consecutive days. The second phase is an observational study in the lab where couples discuss topics related to their diabetes management. The second phase complements the naturalistic observation and experience sampling phase by focusing on the assessment of a full discussion about diabetes-related concerns. Participants are romantic heterosexual couples with one partner having the diagnosis of T2DM. For further research and practice, it is crucial to identify the impact of social support and CDC on couple’s dyadic illness management of T2DM and on their well-being in daily life. Using AAMC will make a key contribution with regard to objective operationalisations of visible and invisible support, CDC, physical activity and well-being. Findings will provide a sound basis for theory- and evidence-based development of dyadic interventions to change health behavior in the context of couple’s dyadic illness management. Challenges of this multimodal sensor approach and feasibility aspects are discussed.

  • Together 5000 (T5K): An online, PrEP-era cohort of vulnerable, HIV-negative gay and bisexual men and transmen and transwomen who have sex with men in the United States and Puerto Rico

    Date Submitted: Feb 14, 2019

    Open Peer Review Period: Feb 15, 2019 - Feb 22, 2019

    Background: Gay, bisexual, and other men who have sex with men (GBM) continue to bear the burden of the HIV epidemic in the U.S., and are among the only populations to see increased incidence in recen...

    Background: Gay, bisexual, and other men who have sex with men (GBM) continue to bear the burden of the HIV epidemic in the U.S., and are among the only populations to see increased incidence in recent years. Objective: To recruit a racially and geographically diverse sample of HIV-negative men who have sex with men (MSM) who are not on PrEP to inform the design, implementation, scale-up, and evaluation of HIV prevention programs. Methods: We used established Internet-based strategies to enroll a large, racially diverse, national sample of HIV-negative GBM aged 16 to 49 at high risk of HIV acquisition via sexual networking apps. Study participants will be contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, HIV diagnosis, and PrEP use (attempts to access, PrEP initiation, PrEP discontinuation). Using serologic data and self-reported HIV testing history, we reconstructed a cohort of men who could all be classified as HIV-negative as of 12 months prior to cohort enrollment to estimate HIV incidence. Results: The study sample included 8,777 participants from all 50 U.S. states, Puerto Rico and Guam; 50.9% (n=4,468) were persons of color, and 25.3% (n=2,221) were young individuals aged 16-24 years. Per eligibility criteria, all T5K participants have sex with 2+ male partners in the 90 days prior to enrollment, being HIV-negative, and not taking PrEP. Additionally, 79.4% reported 2+ insertive condomless anal sex acts (CAS); 60.4% reported 1+ receptive CAS acts in the prior 90 days Participants will complete annual self-administered at-home HIV testing as well as annual at-home online surveys beginning 12 months after the baseline survey. Incidence rate estimates in the 6- and 12-month periods leading up to enrollment were 2.15 (95% CI 1.63-2.81) and 2.41 (95% CI 2.02-2.90) per 100 person-years, respectively. Conclusions: A large, national and racially diverse cohort of HIV-negative GBM at high risk for HIV seroconversion has successfully been recruited online into a longitudinal follow-up. This cohort of GBM at high risk for HIV acquisition can provide important insights related to the real world uptake, impact, and equity of HIV prevention interventions in the U.S. Clinical Trial: n/a

  • The effectiveness of educational mobile messages for assisting the prevention of early childhood caries: a randomized controlled trial protocol

    Date Submitted: Feb 7, 2019

    Open Peer Review Period: Feb 11, 2019 - Feb 25, 2019

    This study aims to evaluate the effectiveness of messages sent via cellphones as an adjuvant method for the prevention of early childhood caries (ECC). A single-blinded, randomized and parallel-group...

    This study aims to evaluate the effectiveness of messages sent via cellphones as an adjuvant method for the prevention of early childhood caries (ECC). A single-blinded, randomized and parallel-group clinical trial will be conducted with dyads of parents/caregivers and children aged between 36 and 60 months, recruited in kindergartens and schools of Bauru-SP. The sample will be randomly assigned to two distinct groups, test and control, according to health literacy levels of parents, and age, gender and oral health status of children. Each 2 weeks, only participants allocated in test group will receive messages via WhatsAppTM containing preventive and education-related ECC information. The dyads will return to dentist each 3 months during a year, in order to the assessment of primary outcomes (sugar consumption, and ICDAS, visible plaque and community periodontal indices), and to receive dental care measures. Secondary outcomes (electronic health literacy and general perceived self-efficacy) will be determined only at baseline and after 12-month follow-up. The quality of randomization will be evaluated throughout the study, comparing test and control groups systematically by Student's t tests for continuous variables and Chi-square for categorical variables. Listwise deletion method will be applied in cases of drop-out, if the missing values satisfy the criteria of missing completely at random (MCAR); otherwise, multiple imputation data strategy will be conducted. The Kolmogorov-Smirnov and Levene tests will be used to determine the normality and homogeneity of data, respectively, which will indicate further statistical analyses for elucidating significant differences between groups (P<0.05). Student's t test or Mann-Whitney U test will be employed for parametric or nonparametric analyses, respectively. The present results will contribute to understand the importance of educational mobile messages towards the adoption of healthy behaviors, and consequently, the prevention of ECC in a given population.