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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: Alcohol misuse and emotional problems (i.e., depression and anxiety) are highly comorbid among Canadian young adults. However, there is a lack of integrated, accessible, and evidence-based...
Background: Alcohol misuse and emotional problems (i.e., depression and anxiety) are highly comorbid among Canadian young adults. However, there is a lack of integrated, accessible, and evidence-based treatment options for these young adults. Objective: The main goal of this study is to develop and test the efficacy of an integrated, online self-help program designed to target both alcohol misuse and emotional problems. Methods: A two-arm randomized controlled trial (RCT) design will be used to compare the efficacy of the online integrated treatment to a psychoeducational control group. A target sample of 214 participants will be recruited and randomly assigned to either condition. The integrated treatment will last 8-weeks and participants will work through 12 modules. Modules will incorporate content based on principles of Cognitive Behavioural Therapy (CBT) and Motivational Interviewing (MI). Participants in the control group will receive links to psychoeducational resources and will have access to the full treatment after follow-up. The primary outcome will be the number of Canadian standard drinks consumed in the week leading up the assessment. Secondary outcomes of interest include symptoms of depression, anxiety, alcohol-related problems, quality of life, and use of other drugs. Assessments will be completed at three time points: at baseline, at the end of treatment (i.e., 8-weeks), and at follow-up (i.e., 24-weeks). Upon completion, data will be analyzed using Generalized Linear Mixed Models (GLMM). Results: Data collection will begin in June 2018 and will continue until January 2020. Final study results will be submitted for publication by July 2020. Conclusions: Currently, there are no integrated treatments designed to target alcohol misuse and the range of emotional problems experienced in young adults. This research stands to provide an effective, accessible (i.e., online), and feasible option to treat the many struggling young adults in this country. Clinical Trial: Clinicaltrials.gov ID – NCT03406039
Background: Fatigue and sleep problems are common after traumatic brain injury (TBI) and are experienced as highly distressing symptoms, playing a significant role in the recovery trajectory and can d...
Background: Fatigue and sleep problems are common after traumatic brain injury (TBI) and are experienced as highly distressing symptoms, playing a significant role in the recovery trajectory and can drastically impact the quality of life and societal participation of the patient and their family and friends. However, the etiology and development of these symptoms is still uncertain. Objective: The aim of this study is to examine the development of fatigue and sleep problems following moderate to severe TBI and explore the changes in underlying biological (pain, brain damage), psychological (emotional state) and social (support family, participation) factors across time. Methods: Longitudinal multicenter observational cohort study with four measurement points (3, 6, 12 and 18 months post injury) including subjective questionnaires and cognitive tasks, preceded by 7 nights of actigraphy combined with a sleep diary. Recruitment of 137 moderate to severe TBI patients presenting at emergency and neurology departments or rehabilitation centers across the Netherlands is anticipated. Results: The evolution of fatigue and sleep problems following TBI and their association with possible underlying biological (pain, brain damage), psychological (emotional state) and social (support family, participation) factors will be examined. Conclusions: To the authors’ knowledge this study is the first study that examines the development of both post-TBI fatigue and sleep longitudinally within a biopsychosocial model in moderate to severe TBI using both subjective and objective measures. Identification of modifiable factors such as mood and psychosocial stressors may give direction to the development of interventions for fatigue and sleep problems post-TBI. Clinical Trial: Dutch Trial Register NTR7162; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=7162 (Archived by WebCite at http://www.webcitation.org/6z3mvNLuy)
Background: High sodium intake is a significant public health problem in the U.S. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants an...
Background: High sodium intake is a significant public health problem in the U.S. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average U.S. diet coming from processed and restaurant foods. Objective: We propose that a mobile application intervention that promotes low sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low sodium diet in hypertension (HTN). Methods: This is a single center prospective open-label design, patients will be randomized to the mobile application or usual care for 8-week duration. Fifty patients greater than 18 years of age diagnosed with hypertension and on antihypertensive therapy for at least 3 months will be randomized in a 1:1 fashion stratified by gender. Study subjects will receive the mobile application, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint of is the change in estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include the change in sodium content of the food frequency questionnaire, confidence in following a low sodium diet, urine chloride and creatinine dipsticks and blood pressure. Conclusion: This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages via a novel mobile application 8-week intervention on urinary sodium excretion in patients with HTN. By testing a novel mobile application intervention, LowSalt4Life, we will address a critical evidence gap in the care of HTN patients. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in HTN. Clinical Trial Registration: ClinicalTrials.gov NCT03099343 (https://clinicaltrials.gov/ct2/show/NCT03099343)
Background: A key concern for people with chronic pain is experiencing increased pain and/or re-injury. Consequently, individuals with chronic pain can develop a maladaptive fear of movement that lea...
Background: A key concern for people with chronic pain is experiencing increased pain and/or re-injury. Consequently, individuals with chronic pain can develop a maladaptive fear of movement that leads to adverse functional consequences. A primary goal of chronic pain rehabilitation is re-engagement in feared movements through exposure. This is often challenging since safe movement can be uncomfortable. Virtual environments provide a promising opportunity to safely and gradually expose Veterans to movements that are avoided in the real world. The current study will utilize multiple virtual reality (VR) applications (APPs) of varying the intensity levels ranging from passive distraction from pain to active exposure to feared movement. The primary aims of this pilot are to examine VR as an adjunctive non-pharmacological intervention to assist with the adoption and implementation of skills to decrease fear of movement and increase overall functioning among Veterans with chronic pain. The second aim is to validate a hierarchy of VR Apps to assist in gradual exposure to feared movements. Methods: This study will be conducted in the Chronic Pain Rehabilitation Program (CPRP) at the James A. Haley Veterans Hospital, a unique inpatient program within the VA system. Participants will include up to 20 Veterans who receive a VR intervention as part of their physical therapy. Intake and discharge measures of pain and functional outcomes will be compared to a historical matched control group comprised from Veterans who previously completed the CPRP. A rating form containing qualitative and quantitative experiences will be administered following each VR session to assess feasibility and to validate the hierarchy. Discussion: This pilot study will inform the feasibility of a multi-site randomized controlled trial examining the clinical utility of using VR to reduce fear of movement and increase function among Veterans with chronic pain. VR has the advantage of being easily implemented both within VA healthcare settings as well as in Veterans’ own residences, where engagement in ongoing self-management approaches is often most challenging. Presumably, VR that is matched to patient functioning, progresses in intensity, immerses Veterans in the applications, and is perceived positively by Veterans, will result in positive functional outcomes.
Background: Increasing number of Massive Open Online Courses (MOOCs) are being used to train learners at scale in various healthcare related skills. However, many challenges in course delivery require...
Background: Increasing number of Massive Open Online Courses (MOOCs) are being used to train learners at scale in various healthcare related skills. However, many challenges in course delivery require further understanding, for example, factors exploring the reasons for high MOOC dropout rates, recorded low social interaction between learners and the lack of understanding of the impact of a course facilitators’ presence in course engagement. There is a need to generate further evidence to explore these detriments to MOOC course delivery to enable enhanced course learning design. Objective: This protocol aims to describe the design of a study evaluating learners knowledge, skills and attitudes in a Massive Open Online Course (MOOC) about data science for healthcare. Methods: This study will use two evaluation models: 1) The RE-AIM framework and the 2) Kirkpatrick model drawing data from pre and post-course surveys and post-MOOC semi-structured interviews. The primary goal of the evaluation is to appraise participants' knowledge, skills, and attitude after taking the MOOC. Results: A summary of the research findings will be reported through a peer-reviewed journal and will be presented at an international conference. Conclusions: The proposed multi-method evaluation of the MOOC was determined based on the MOOC’s aims and objectives and the methodological approaches used to evaluate this type of a course. The MOOC evaluation will help appraise the effectiveness of the MOOC in delivering its intended objectives. Clinical Trial: Ethics approval for this study was obtained from Imperial College London through the Education Ethics Review Process (EERP) (EERP1617-030).
Background: The need of services to support patient self-care and patient education has been emphasized for patients with chronic conditions. People with chronic conditions may spend many hours per ye...
Background: The need of services to support patient self-care and patient education has been emphasized for patients with chronic conditions. People with chronic conditions may spend many hours per year in health and social care services, but the majority of time is spent in self-care. This has implications for how health care is best organized. The term co-care specifically stresses the combination of health care professionals’ and patients’ resources, supported by appropriate (digital) tools for information exchange, to achieve best possible health outcomes for patients. Developers of eHealth services need to consider both parties’ specific needs for the service to be successful. Research on participants’ experiences of participating in codesign sessions is scarce. Objective: The aim of this study was to describe different stakeholders’ (people with chronic conditions, health care professionals, and facilitators) overall experiences of participating in codesign workshops aimed at designing an eHealth service for co-care for Parkinson’s disease, with a particular focus on the perceptions of values and challenges of codesign, as well as improvement suggestions. Methods: Four half-day codesign workshops were performed with 7 people who have Parkinson’s disease and 9 health care professionals. Data were collected during the workshop series using formative evaluations with participants and facilitators after each workshop, researchers’ diary notes throughout the codesign process, and a web-based questionnaire after the final workshop. The quantitative data from the questionnaire were analyzed using descriptive statistics. The qualitative data were triangulated and analyzed inductively using qualitative content analysis. Results: The quantitative ratings showed that most participants had a positive general experience regarding the codesign workshops. The qualitative analysis resulted in six categories and 30 subcategories describing respondents’ perceptions of the values and challenges of codesign and their improvement suggestions. The categories concerned 1) desire for more stakeholder variation; 2) imbalance in the collaboration between stakeholders; 3) time-investment and commitment paradox; 4) desire for both flexibility and guidance; 5) relevant workshop content, but concerns about goal achievement; and 6) hopes and doubts about future care. Conclusions: Based on the identified values and challenges, some paradoxical experiences were revealed: a) a desire to involve more stakeholders in codesign, while preferring to work in separate groups; b) a desire for more preparation and discussions, while the required time investment was a concern; and c) the experience that codesign is valuable for improving care, while there are doubts about the realization of co-care in practice. The value of codesign is not mainly about creating new services; it’s about improving current practices to shape better care. The choice of methods needs to be adjusted to the stakeholder group and context, which will influence how they experience the process and outcomes of codesign.