JMIR Research Protocols
Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
JMIR Research Protocols (ISSN 1929-0748) publishes 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 new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2016: 5.175)
JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions
JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central
Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort
JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal
JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols
JMIR Res Protoc 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)
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Latest Submissions Open for Peer-Review:View All Open Peer Review Articles
Patient and Provider Engagement and Empowerment through Technology (P2E2T2) to Improve Health in Diabetes: A Randomized Controlled Trial Protocol Using mHealth Technology and Nurse Health Coaching
Date Submitted: Oct 16, 2017
Open Peer Review Period: Oct 17, 2017 - Oct 31, 2017
Background: Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological tr...
Background: Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. Objective: The objective of this clinical trial is to evaluate the impact of a mobile health enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. Methods: A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the Electronic Health Record to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at three and nine months. Primary and secondary outcomes include diabetes self-efficacy, HgbA1C, and quality of life measures. Results: Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. Conclusions: This protocol details a patient-centered intervention using nurse health coaching, mobile health technologies, and integration of patient-generated data into the electronic health record. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity, by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback loop by bringing patient generated data into the electronic health record. Clinical Trial: ClinicalTrials.gov NCT 02672176
An integrated approach to fight parasitic worm infections and diarrhoea: a cluster randomised trial study protocol
Date Submitted: Oct 12, 2017
Open Peer Review Period: Oct 14, 2017 - Oct 28, 2017
Background: The global strategy to control helminthiases emphasises preventive chemotherapy. However, in the absence of access to clean water, improved sanitation and adequate hygiene, re-infection af...
Background: The global strategy to control helminthiases emphasises preventive chemotherapy. However, in the absence of access to clean water, improved sanitation and adequate hygiene, re-infection after treatment can occur rapidly. Hence, integrated approaches are necessary to sustain preventive chemotherapy and make progress towards interruption of helminthiases transmission. Objective: The aim of the current study is to assess and quantify the effect of an integrated control package that consists of preventive chemotherapy, community-led total sanitation (CLTS) and health education, on soil-transmitted helminthiasis, schistosomiasis, intestinal protozoa infection and diarrhoea in rural Côte d’Ivoire. Methods: In a first step, a community health education programme will be developed that includes an animated cartoon for hygiene and health targeting school-aged children, coupled with a community health education theatre for the entire community. In a second step, a cluster randomised trial will be implemented in 56 communities of south-central Côte d’Ivoire with four intervention arms: (i) preventive chemotherapy; (ii) preventive chemotherapy plus CLTS; (iii) preventive chemotherapy plus health education; and (iv) all three interventions combined. In a third step, a baseline parasitological, anthropometric and hygiene-related knowledge, attitudes, practices and beliefs (KAPB) survey will be conducted. These surveys will be repeated 18 and 39 months after the baseline cross-sectional survey to determine the effect of different interventions on helminth and intestinal protozoa infection, nutritional indicators and KAPB. Monitoring of diarrhoea will be done over a 24-month period at 2-week intervals, starting right after the baseline survey. Results: This study will allow determining the effect of an integrated, community-based approach on infection patterns of intestinal parasites and diarrhoeal incidence, anthropometric measures and hygiene-related KAPB. Conclusions: The acceptability of an integrated control package in the community will be evaluated, including strengths and limitations. Clinical Trial: ISRCTN53102033 (assigned: 26 March 2014).
Type 1 Doing Well: Randomized Pilot Study Protocol for a Strengths-Based Behavioral Intervention for Parents of Adolescents with Type 1 Diabetes Using an mHealth App
Date Submitted: Oct 13, 2017
Open Peer Review Period: Oct 14, 2017 - Oct 28, 2017
Background: Supportive parent involvement for adolescents’ type 1 diabetes self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative...
Background: Supportive parent involvement for adolescents’ type 1 diabetes self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. Objective: This protocol describes the development of a new, strengths-based behavioral intervention for parents of adolescents with type 1 diabetes delivered via mobile-friendly web app called Type 1 Doing Well. Methods: Ten adolescent-parent dyads and five diabetes care providers participated in a series of qualitative interviews to inform the design of the app. The 3-month pilot intervention will involve n=82 parents receiving daily prompts to use the app, in which they will mark the diabetes-related strength behaviors (i.e., positive attitudes or behaviors related to living with or managing type 1 diabetes) their teen engaged in that day. Parents will also receive training on how to observe diabetes strengths and how to offer teen-friendly praise via the app. Each week, the app will generate a summary of the teen’s most frequent strengths from the previous week based on parent reports, and parents will be encouraged to praise their teen either in person or from a library of reinforcing text messages. Results: The major outcomes of this pilot study will include intervention feasibility and satisfaction data. Clinical and behavioral outcomes will include glycemic control, regimen adherence, family relationships and conflict, diabetes burden, and health-related quality of life. Conclusions: This strengths-based, mHealth intervention aims to help parents increase their awareness of and efforts to support their adolescents’ engagement in positive diabetes-related behaviors. If efficacious, this intervention has the potential to reduce the risk of family conflict, enhance collaborative family teamwork, and ultimately improve diabetes outcomes. Clinical Trial: NCT02877680
Cultural and contextual adaptation of an eHealth intervention: Adaptation framework and protocol for Horyzons-Canada
Date Submitted: Oct 12, 2017
Open Peer Review Period: Oct 14, 2017 - Oct 28, 2017
Background: eHealth interventions have the potential to address challenges related to access, service engagement, and continuity of care in the delivery of mental health services. However, the initial...
Background: eHealth interventions have the potential to address challenges related to access, service engagement, and continuity of care in the delivery of mental health services. However, the initial development and evaluation of such interventions can require substantive amounts of financial and human resource investments to bring them to scale. Therefore, it may be warranted to increase policy, services, and research attention on eHealth platforms that have the potential to be adapted for use across settings. Yet, limited attention has been placed on the methods and processes for adapting eHealth interventions to improve their applicability across cultural, geographical, and contextual boundaries. Objective: In this paper, we describe an adaptation framework and protocol to adapt an eHealth intervention designed to promote recovery and prevent relapses in youth receiving specialized services for first-episode psychosis. The online platform, called Horyzons, was originally developed and tested in Australia and is being prepared for a wider evaluation in Canada. Methods: Service users and service providers from two specialized early intervention programs for first-episode psychosis located in different provinces will explore a beta-version of the eHealth intervention through focus group discussions and extended personal explorations to identify the need for, and content of contextual and cultural adaptations. An iterative consultation process will then take place with service providers and users to develop and assess platform adaptations in preparation for a pilot study with a live version of the platform. Results: Data collection has been completed August 2017 and analysis is in process. Conclusions: This protocol contributes to an important gap in the literature pertaining to the specific principles, methods and steps involved in conducting a systematic reflection and change process in scaling up the evaluation of eHealth interventions across a diverse range of healthcare settings. Clinical Trial: N/A
DIABEO-telemedicine versus usual follow-up in the treatment of diabetic patients poorly controlled with a basal-bolus insulin regimen: the TELESAGE randomized, open label trial
Date Submitted: Oct 10, 2017
Open Peer Review Period: Oct 13, 2017 - Oct 27, 2017
Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal....
Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a software application uploaded onto smartphones (with an Internet connection) for calculation of bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO is associated with a significant improvement of glycemic control in poorly controlled diabetes type 1 (DT1) patients, particularly when combined with physicians’ teleconsultations. Here, we present the protocol of a new study (TELESAGE) conducted in a larger population of poorly controlled diabetic patients. Methods: TELESAGE is a multicentre, double-randomized, open-label, three parallel-arms study, conducted in approximately 100 centers in France. The study compares a control group (arm 1: usual follow-up) versus two DIABEO-telemedicine systems: one with physician-telemedicine (arm 2) and the other with nursing tele-monitoring and teleconsultations by diabetologist’s task delegation (arm 3). A first randomization step will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE is to demonstrate the superiority of a 12-month follow-up by the DIABEO-telemedicine system versus usual follow-up, with respect to improvement of HbA1c levels in approximately 696 DT1 or DT2 patients poorly controlled by a basal-bolus insulin regimen. Here, we present the baseline the protocol of the TELESAGE study. Discussion: The TELESAGE study is expected to confirm the previous results of TELEDIAB 1 study in a larger sample of diabetic patients. It is also expected to evaluate a nurse tele-monitoring system. If this is the case, the DIABEO-telemedicine service will clearly demonstrate its utility to become an integral part of the ambulatory care of an intensive insulin regimen treated patient. The study was registered by the French ANSM (Agence Nationale de Sécurité du Médicament; National Agency for Drug Safety) under Trial ID number: 2012-A00072-41.
Evaluating the CARE4Carer blended care intervention for partners of patients with acquired brain injury: protocol for a randomized controlled trial
Date Submitted: Oct 8, 2017
Open Peer Review Period: Oct 9, 2017 - Oct 23, 2017
Background: Support programs for partners of patients with acquired brain injury are necessary, since these partners experience several unfavorable consequences of caregiving, such as a high burden, e...
Background: Support programs for partners of patients with acquired brain injury are necessary, since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psycho-education, skill building, problem solving and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. Objective: This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. Methods: A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. Results: The effect of the intervention on the primary and secondary outcome measures will be determined. Additional economic and process evaluations will be conducted. Conclusions: The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. Clinical Trial: Dutch Trial Register NTR6197, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197