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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.
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: Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people with T1D are diagnosed at a young age and parents have to take on the responsibility of T1D man...
Background: Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people with T1D are diagnosed at a young age and parents have to take on the responsibility of T1D management. Eventually, the child must begin to transition to self-management. Adolescents often struggle to take on responsibility for all the necessary tasks to successfully self-manage their T1D. In fact, approximately three-quarters of adolescents are not achieving ADA HbA1c targets. This lack of adherence can lead to negative health outcomes, such as the development of diabetic ketoacidosis, increased infections, and hospitalizations. Objective: The goals of this interdisciplinary proposal are: (1) to develop a unique and theory-driven technology using a mobile phone application (app) to promote self-management behaviors for adolescents aged 10 to 15 years with T1D and their parents; and (2) to explore the feasibility and impact of the self-management mobile app. Methods: This study has two phases: app development and pilot testing. In the app development phase, the app will be conceptualized and a prototype will be tested. In phase two, the mobile app will undergo pilot testing to determine its feasibility and impact on diabetes self-management. Results: The pilot test was launched in September 2017. Data collection is underway and results are forthcoming. Conclusions: Adolescents with type 1 diabetes and their parents often struggle during the transition from parent care to adolescent self-management. This transition to young adulthood is challenging for all families, but families facing the added complexity of diabetes management often find this time especially challenging. The proposed intervention aims to shift diabetes management responsibility to the adolescent and increase their independence, while encouraging parents to remain engaged and supportive of their adolescent in an effort to ease some difficulties of this challenging time. Clinical Trial: ClinicalTrials.gov Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens Identifier: NCT03436628 https://clinicaltrials.gov/ct2/show/NCT03436628
Background: Leisure-time physical activity (LTPA) is a critical component of a healthy lifestyle for individuals with spinal cord injury (SCI). However, most individuals are not sufficiently active to...
Background: Leisure-time physical activity (LTPA) is a critical component of a healthy lifestyle for individuals with spinal cord injury (SCI). However, most individuals are not sufficiently active to accrue health benefits. The Active Living Lifestyles program for individuals with SCI who use manual wheelchairs (ALLWheel) targets important psychological factors that are associated with LTPA uptake and adherence, while overcoming some barriers associated with participation restrictions. Objective: To describe the protocol for the development and evaluation of the ALLWheel program for individuals with SCI who use manual wheelchairs. Methods: Complete the first three stages of the Medical Research Council Framework for developing and evaluating complex interventions (i.e., pre-clinical, modeling, exploratory). The pre-clinical phase will consist of scoping and systematic reviews and review of theory. The intervention will be modelled by expert opinions and consensus through focus groups and Delphi surveys with individuals with SCI, clinicians, and community partners. Finally, the feasibility and potential influence of the ALLWheel program on LTPA and psychological outcomes will be evaluated. Results: This project is funded by the Craig H Neilsen Foundation, the Fonds de Recherche du Québec – Santé, and the Canadian Disability Participation Project and is currently underway. Conclusions: Using peer trainers and smartphone technology may help to cultivate autonomy-supportive environments that also enhance self-efficacy. Following a framework for developing and evaluating a novel intervention, which includes input from stakeholder input at all stages, will ensure the final product (i.e., a replicable intervention) is desirable for knowledge users and ready for evaluation in a RCT. If effective, the ALLWheel program has the potential to reach a large number of individuals with SCI to promote LTPA uptake and adherence. Clinical Trial: N/A
Background: Sexually transmitted infection (STI) rates are increasing in the United States, with approximately half of new infections occurring among adolescents age 15-24 years. Gay, bisexual, and tr...
Background: Sexually transmitted infection (STI) rates are increasing in the United States, with approximately half of new infections occurring among adolescents age 15-24 years. Gay, bisexual, and transgender youth (GBTY), homeless youth, and youth with histories of drug use, mental health disorders, and incarceration are all at uniquely high risk for STIs. However, these adolescents often lack access to sexual health services. In this study, we are using point-of-care STI tests in community-based settings to screen for and treat STIs in adolescents. Methods: We are recruiting 1500 HIV-uninfected youth and 220 HIV-infected youth from homeless shelters, GBTY organizations, and community health centers in Los Angeles, California and New Orleans, Louisiana. Study participants receive STI screening every 4 months for 24 months. STI screening includes rapid HIV, syphilis, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Hepatitis C Virus testing. Trained paraprofessionals conduct all STI testing. When a participant screens positive for an STI, they are either linked to a partner medical clinic or provided with same-day antibiotic therapy and expedited partner therapy. We monitor STI prevalence among study participants, as well as point-of-care test performance, linkage-to-care, and treatment outcomes. Discussion: As STI rates continue to rise, it is important to improve access to screening and treatment services, particularly for high-risk adolescents. In this study, we aim to evaluate the use of point-of-care STI diagnostic tests in community-based organizations. We hope to determine the prevalence of STIs among those adolescents and evaluate the effectiveness of community-based STI screening programs.
Background: Among youth living with HIV (YLH) aged 12-24 years old linked to health care, only 30% to 40% are virally suppressed. YLH must achieve viral suppression, in order to reduce the probability...
Background: Among youth living with HIV (YLH) aged 12-24 years old linked to health care, only 30% to 40% are virally suppressed. YLH must achieve viral suppression, in order to reduce the probability of infecting others, as well as increasing the length and quality of their own life. Objective: We are conducting a randomized controlled trial to evaluate the efficacy of an Enhanced Standard Care condition (n = 110) compared to a Stepped Care Intervention condition (n = 110) to increase viral suppression among YLH. Methods: YLH (N = 220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community based organizations in Los Angeles, CA and New Orleans, LA, USA. YLH will be randomly assigned to one of two study conditions: 1) Enhanced Standard Care: which includes standard clinical care plus an Automated Messaging and Monitoring Intervention (AMMI); or, 2) a Stepped Care: which includes three levels of intervention (1-AMMI; 2- Peer Support via social media plus AMMI; or a 3-Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at four-month intervals for 24 months. For the Stepped Care intervention group, those who do not achieve viral suppression at any four-month assessment will “step” up to the next level of intervention. Secondary outcomes will be sexually transmitted infections (STIs), serious substance abuse, retention in care, and antiretroviral therapy (ART) adherence. Results: N/A Conclusions: This is the first known application of a stepped care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost effective method of helping YLH achieve viral suppression and improve their quality of life. Clinical Trial: www.clinicaltrials.gov registration # NCT03109431 registered April 12, 2017
Background: New Zealand urgently needs scalable, effective healthy lifestyle support programmes tailored to the needs and lived contexts of Māori and Pasifika communities. Objective: The primary obje...
Background: New Zealand urgently needs scalable, effective healthy lifestyle support programmes tailored to the needs and lived contexts of Māori and Pasifika communities. Objective: The primary objective of this study is to determine the effects of a co-designed, culturally-tailored, lifestyle support mHealth tool (the OL@-OR@ smartphone app and website) on key risk factors and behaviours associated with an increased risk of non-communicable disease (diet, physical activity, smoking and alcohol consumption) compared to a control condition. Methods: A 12-week, community-based, two-arm, cluster randomised controlled trial will be conducted across New Zealand January to December 2018. Participants (target n=1280; 64 clusters [32 Māori, 32 Pasifika]; 32 clusters per arm [16 Māori, 16 Pasifika]; 20 participants per cluster) will be individuals aged 18 years and older who identify with either Māori or Pasifika ethnicity, live in New Zealand, are interested in improving their health and wellbeing or making lifestyle changes, and have regular access to a smartphone, tablet or laptop/computer and to the internet. Clusters are identified by Community Coordinators and will be randomly assigned (1:1 ratio) to one of two groups: 1) the full OL@-OR@ app, or 2) a control version of the app (data collection only plus a once-weekly notification), stratified by geographic location (Auckland or Waikato) for Pasifika clusters and by region (rural, urban or provincial) for Māori clusters. All participants will provide self-reported data at baseline, and 4- and 12-weeks post randomisation. The primary outcome is adherence to healthy lifestyle behaviours measured using a self-reported composite health behaviour score at 12 weeks, that assesses smoking behaviour, fruit and vegetable intake, alcohol intake, and physical activity. Secondary outcomes include self-reported body weight, holistic health and wellbeing status, medication use, and recorded engagement with OL@-OR@ tool. Results: The trial started recruitment on 22/01/2018 and is currently ongoing. Recruitment is expected to take six months (protocol version 3, 11/04/2018. Trial findings are expected to be available December 2018 Conclusions: Currently there are no scalable, evidence-based tools to support Māori or Pasifika who want to improve their eating habits, lose weight, or be more active. This wait-list controlled, cluster randomised trial will assess the effectiveness of a co-designed, culturally tailored mHealth tool to support healthy lifestyles. Clinical Trial: Australia New Zealand Clinical Trials Register ACTRN12617001484336. Registered on 20/10/2017; http://www.ANZCTR.org.au/ACTRN12617001484336.aspx.
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Background: Advancing technology has increased functionality and permitted more complex study designs for behavioral interventions. Investigators need to keep pace with these technological advances in...
Background: Advancing technology has increased functionality and permitted more complex study designs for behavioral interventions. Investigators need to keep pace with these technological advances in order for Electronic Data Capture (EDC) systems to be appropriately executed and utilized at full capacity in research settings. Mobile technology allows EDC systems to collect near real-time data from study participants; deliver intervention directly to participants’ personal mobile devices; monitor staff activity; and facilitate near real-time decision making during study implementation. Objective: This paper presents the infrastructure of an EDC system that was designed to support a multi-site HIV bio-behavioral intervention trial in Los Angeles and New Orleans (ATN CARES). We provide an overview of how multiple EDC functions can be integrated into a single EDC system to support large-scale intervention trials. Methods: The CARES EDC system is designed to monitor and document multiple study functions, i.e. screening, recruitment, retention, intervention delivery, and outcome assessment. SMS messaging and nearly all data collection are supported by the EDC system. The system functions on mobile phone, tablet, and web-browsers. Results: ATN CARES is enrolling study participants and collecting baseline and follow-up data through the EDC system. In addition to data collection, the EDC system is being used to generate multiple reports that inform recruitment planning, budgeting, intervention quality and field staff supervision. The EDC system is supporting both incoming and outgoing text messages and offers a high level of data security. Intervention design details are also influenced by EDC system platform capabilities and constraints. Challenges of using the EDC systems are addressed through programming updates and training on how to improve data quality. Conclusions: There are three key considerations in the development of an EDC system for an intervention trial. First, it needs to be decided if the flexibility provided by the development of a study-specific in-house EDC system is needed relative to the utilization of an existing commercial platform that requires less in-house programming expertise. Second, a single EDC system may not provide all functionality. ATN CARES is using a main EDC system for data collection, SMS interventions and case management and a separate online platform to support an online peer-support intervention. Decisions need to be made about the functionality that is crucial for the EDC system to handle and what functionality can be handled by other systems. Third, data security is a priority but needs to be balanced with the need for flexible intervention delivery. For example, ATN CARES is delivering SMS text messages to study participants’ mobile phones. EDC data security protocols should be developed with guidance from security experts and from formative consulting with the target study population as to their perceptions and needs.