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Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
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"!
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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).
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.
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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
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)
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
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