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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 2016: 5.175).
While the original focus was on eHealth studies, JMIR Res Protoc now publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions.
JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central.
Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort.
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: A growing body of evidence supports the use of lifestyle interventions for preventing or delaying the onset of Alzheimer’s disease (AD) and other forms of dementia in at-risk individuals...
Background: A growing body of evidence supports the use of lifestyle interventions for preventing or delaying the onset of Alzheimer’s disease (AD) and other forms of dementia in at-risk individuals. The development of virtually delivered programs would increase the scalability and reach of these interventions, but requires validation to ensure similar efficacy to brick and mortar options. Objective: The objectives of this study are to examine the impact of a remotely delivered lifestyle intervention on (1) cognitive function, (2) depression and anxiety, and (3) various lifestyle behaviors, including diet, exercise, and sleep. Supplemental analyses will explore participants’ engagement patterns with the program, as well as the relationships between program engagement and outcomes. Here we report the study design and data analysis plan, as well as the baseline participant characteristics of the sample for the virtual cognitive health (VC Health) study. Methods: Older adults (age 60-75) with subjective memory decline as measured by the Subjective Cognitive Decline (SCD-9) questionnaire, and who reported feeling worried about their memory decline, were eligible to participate in this single-arm pre-post study. All participants enrolled in the year-long virtual intervention, which consists of health coach-guided lifestyle change for improving diet, exercise, sleep, stress, and cognition. All components of this study were conducted virtually, including the collection of data and the administration of the intervention. Participants were assessed at baseline, 12 weeks, 24 weeks, and 52 weeks with online surveys and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test. Intention-to-treat analysis will be conducted on all outcomes. Results: A total of 85 participants enrolled in the intervention and 82 are included in the study sample (3 participants withdrew). The study cohort is 74% female, 88% Caucasian, 78% overweight or obese, and 67% have at least a college degree. The average baseline RBANS score was 95.9±11.1, which is within age-adjusted norms. The average SCD-9 score was 6.0±2.0, indicating minor subjective cognitive impairment at the beginning of the study. Average baseline Generalized Anxiety Disorder (GAD-7) scores were 6.2±4.5 and Patient Health Questionnaire (PHQ-9) scores were 8.5±4.9, indicating mild levels of anxiety and depression at baseline. Conclusions: Virtually delivered lifestyle interventions represent a scalable solution for the prevention or delay of AD. The results of this study will provide the first evidence for the efficacy of a fully remote intervention and lay the groundwork for future investigations. Clinical Trial: NCT02969460
Background: Prevention of childhood obesity is a key approach to the primary prevention of non-communicable diseases. Several models, based on population health approach and aligned with ecological mo...
Background: Prevention of childhood obesity is a key approach to the primary prevention of non-communicable diseases. Several models, based on population health approach and aligned with ecological models, are used to design childhood obesity prevention programs around the world. Objective: The purpose of this study is to determine the efficacy of “Iran Healthy Start (IHS)/Aghazi Salem, Koodake Irani” -the customized Iranian version of Canadian Healthy Start/Deport Santé health promotion program- which is now being developed in Mashhad University of Medical Sciences (Mashhad, Iran), and focuses on improving physical activity and healthy eating among preschool children. Methods: The intervention will be evaluated by a pilot randomized controlled design. The components of intervention are including customized Decoda online resources for children, implementation guide for educators and managers, training and monitoring, communication and knowledge exchange, building partnership and parent engagement. Outcomes include changes in anthropometry, physical activity level, nutritional risk status and dietary intake and quality of life. Results: Double burden of malnutrition in early years children is a major health concern in developing countries. This justifies the need for health promotion programs that specifically designed to target both over- and under-nutrition prevention. Conclusions: If the efficacy approved, Iran Healthy Start has the potential of a comprehensive health promotion program for young children whose life style behaviors can be improved toward a healthy future life in a nutrition transition setting. Clinical Trial: The study is registered in the Iranian Registry for Clinical Trials (IRCT) (ID: IRCT2016041927475N1-11/12/2016) and is accessible through the WHO database of clinical trial registries.
Background: Despite the evidence of the adverse consequences of immobility during hospitalization, patients spend most of the time in bed. While physical activity is a modifiable factor which can prev...
Background: Despite the evidence of the adverse consequences of immobility during hospitalization, patients spend most of the time in bed. While physical activity is a modifiable factor which can prevent in-hospital functional decline, bed rest is deep rooted in the hospital culture. To attack this, a multidimensional approach is needed. Therefore, Hospital in Motion, a multidimensional implementation project, was designed to improve physical behaviour during hospitalization. Methods: The Hospital in Motion study will be implemented within two specialism (cardiology and oncology) in a Dutch University Medical Centre. Per ward, multidisciplinary teams are composed and follow a step-by-step multidimensional implementation approach which includes the development and implementation of tailored action plans with multiple interventions to stimulate physical activity in daily care. The aim of this study is to investigate the effectiveness of Hospital in Motion on physical behaviour, measured with the behavioural mapping method, one year after start of the project. A pre-post observational study is used to evaluate the effectiveness, including 80 patients per time point per specialism. In addition, the process evaluation will be measured per ward, with a caregivers survey, patient statements and semi-structured interviews with patients and caregivers. Conclusion: This study will provide information about both the effectiveness of the Hospital in Motion project on physical behaviour as in the procedures of an implementation process aimed to incorporate physical activity in usual care. These insights will be useful for others interested in changing physical behaviour during hospitalization.
Background: Sleep disturbance in adolescents is common with up to one third reporting significant symptoms of insomnia. Research with adults has demonstrated that online cognitive behavioural therapy...
Background: Sleep disturbance in adolescents is common with up to one third reporting significant symptoms of insomnia. Research with adults has demonstrated that online cognitive behavioural therapy for insomnia (CBTi) can improve both sleep and mental health. However, research with adolescents is lacking and we know little about whether CBTi would have similar effects with this younger population. Objective: This study aims to assess the feasibility of adding supported online CBT for insomnia to the usual care of young people aged 14-17 years attending specialist child and adolescent mental health services. Methods: This is an open trial where we will recruit young people (n=50) aged 14-17 attending specialist child and adolescent mental health services (CAMHS) with symptoms of insomnia. In addition to their usual care, young people will be provided with Sleepio, a 6 session, online CBTi self-help programme for insomnia. Sleepio teaches a range of techniques including sleep hygiene, relaxation training, stimulus control, sleep restriction and cognitive techniques which participants will be helped to apply through brief weekly telephone support calls. Questionnaires and interviews will be completed at baseline and post-intervention (8 weeks) and will assess sleep, symptoms of depression and anxiety and acceptability of Sleepio and telephone support. Results: Recruitment started in May 2018 and will continue until the end of September 2018. Conclusions: This study will provide preliminary evidence about whether supported online CBTi is acceptable to young people with mental health problems and the post-intervention effects on sleep and symptoms of anxiety and depression. This information will determine whether a randomised trial to determine the effectiveness of Sleepio should be undertaken. Clinical Trial: N/A
Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE...
Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy, primarily because this outcome poses many methodological challenges. The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) was formed in 2016 as an international collaboration with the Centers for Disease Control and Prevention, Abt Associates, and study sites in Australia, Canada, Israel, and the United States. The primary goal of this collaboration is to estimate IVE in preventing acute respiratory or febrile illness (ARFI) hospitalizations associated with laboratory-confirmed influenza virus infection during pregnancy. Secondary aims include: 1) estimating the incidence of influenza-associated ARFI hospitalization during pregnancy; 2) comparing the characteristics of ARFI-hospitalized pregnant women who were tested for influenza to those who were not tested; 3) describing the severity of influenza and non-influenza ARFI hospitalization during pregnancy; 4) describing the clinical course of respiratory syncytial virus (RSV)-associated hospitalization during pregnancy; 5) describing influenza vaccination coverage in pregnant women; and 6) comparing birth outcomes among women with laboratory-confirmed influenza-associated hospitalization vs. other non-influenza ARFI hospitalizations. For an initial assessment of IVE, sites identified a retrospective cohort of pregnant women aged 18 through 50 years whose pregnancies overlapped with local influenza seasons from 2010 through 2016. Pregnancies were defined as those that ended in a live birth or stillbirth of at least 20 weeks gestation. The analytic sample for the primary IVE analysis was restricted to pregnant women who were hospitalized for ARFI during site-specific influenza seasons and clinically tested for influenza virus infection using real-time reverse transcription polymerase chain reaction. In addition to addressing the primary question about the effectiveness of influenza vaccination, PREVENT data will address other important knowledge gaps including understanding the incidence, clinical course, and severity of influenza-related hospitalizations during pregnancy. The data infrastructure and international parternships created for these analyses may be useful and informative for future influenza studies.
Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary pr...
Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease (CVD) are lacking. Objective: The 3R (Ready to Reduce Risk) Study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. This protocol paper details the design and rationale for the study. Methods: An open, pragmatic, randomised controlled trial with 12 months follow-up. Participants were recruited from primary care and randomised on a 1:1 basis, stratified by sex and age, to either a control group (‘usual’ GP care) or an intervention group involving two group, facilitated education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognised behavioural change techniques. The primary outcome was medication adherence to statins. The primary measure is an objective, novel, urine-based biochemical measure of medication adherence. The Morisky 8-item Scale was also used to assess medication adherence. Secondary outcomes include changes in total cholesterol, blood pressure, high-density lipoprotein, TC:HDL ratio, body mass index , waist-to-hip ratio, waist circumference, smoking behaviour, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs and overall CVD risk score. Process outcomes relating to acceptability and feasibility of the 3R Intervention have also been considered. Results: 212 participants were recruited between May 2015 and March 2017. The 12 month follow-up data collection clinics were completed in April 2018 and data analysis will commence once all study data has be collected and verified. Conclusions: This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of CVD. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures Clinical Trial: ISRCTN16863160