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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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Background: Substance use is an alarming public health issue, associated with significant morbidity and mortality. Adolescents and emerging adults are at particularly high risk because substance use t...
Background: Substance use is an alarming public health issue, associated with significant morbidity and mortality. Adolescents and emerging adults are at particularly high risk because substance use typically initiates and peaks during this developmental period. Mobile health apps are a promising data collection and intervention delivery tool for substance-using youth, as most teens and young adults own a smartphone. However, engagement with data collection for most mobile health applications is low and often large fraction of users stop providing data after a week of use. Objective: Substance Abuse Research Assistant (SARA) is a mobile application to increase and/or sustain engagement of substance data collection overtime. SARA provides a variety of engagement strategies to incentivize data collection: a virtual aquarium in the app grows with fish and aquatic resources; occasionally funny or inspirational contents (e.g., memes or text messages) are provided to generate positive emotions. We plan is to assess the efficacy of SARA’s engagement strategies over time by conducting a micro-randomized trial, where the engagement strategies will be sequentially manipulated. Methods: We aim to recruit participants (ages 14-24, who report any binge-drinking or marijuana use in the past month. Participants are instructed to use SARA for one month. During this month, participants are asked to complete one survey and two active tasks every day between 6PM and midnight. The survey assesses participants’ daily mood, stress level loneliness, and hopefulness, while the active tasks measure reaction time and spatial memory. To incentivize and support the data collection, a variety of engagement strategies are used. First, pre-data collect strategies include: (i) At 4PM, a push notification may be issued with an inspirational message from a contemporary celebrity; or, (ii) At 6PM, a push notification may be issued reminding about data collection and incentives. Second, post-data collection strategies include various rewards such as points which can be used to grow a virtual aquarium with fishes and other treasures and modest monetary rewards (up to $13; $1 for each 3-day streak); also, participants may receive funny/inspirational content as memes/gifs, or visualizations of prior data. During the study, participants will be randomized every day to receive different engagement strategies. Results: The micro-randomized trial started on August 21, 2017 and is currently recruiting. The trial will end on February 28, 2018. Conclusions: To the best of our knowledge, SARA is the first mobile phone app that systematically manipulates engagement strategies in order to identify the best sequence of strategies that keep participants engaged in data collection. Once the optimal strategies to collect data are identified, future versions of SARA will use this data to provide just-in-time adaptive interventions (JITAIs) to reduce substance use among youth. Clinical Trial: https://clinicaltrials.gov/show/NCT03255317
Hyperopia is a known risk factor for the development of strabismus and amblyopia. In addition to visual consequences there is a growing body of evidence that uncorrected hyperopia may have a negative...
Hyperopia is a known risk factor for the development of strabismus and amblyopia. In addition to visual consequences there is a growing body of evidence that uncorrected hyperopia may have a negative impact on educational attainment and visuocognitive and visuomotor skills. Currently, hyperopia receives much less attention from research than myopia even though the impact of moderate to high levels of hyperopia especially in one eye (anisohyperopia) can lead to amblyopia if not corrected fully at a young age. Hyperopia occurs as a consequence of insufficient ocular growth and a failure to emmetropise in childhood with the majority of hyperopic refractive errors resulting from an eye that is too short for its refractive power. In anisohyperopia it is unclear why one eye may remain hyperopic while the fellow eye grows towards an emmetropic state. Studies on animals have suggested that manipulating peripheral defocus through an optical means while simultaneously providing correct axial focus can either discourage or encourage axial eye growth to effectively treat myopia or hyperopia, respectively. Recent research has established that progression of myopia and axial eye growth can be significantly reduced in children and adolescents through the use of bifocal or multifocal contact lenses. These contact lenses while correcting the distance central myopia impose simultaneous myopic defocus. In recent years there has been a great deal of interest in delaying progression of myopia (short-sightedness) by slowing eye growth using a particular type of contact lens termed a centre-distance multifocal design. There have been encouraging results in this area to date. The proposed study here would explore the use of centre-near multifocal design contact lenses to encourage eye growth, thereby reducing hyperopia. There are three elements to the programme of research: 1. The natural progression of axial eye growth and refractive error will be measured in spectacle wearing hyperopic and anisohyperopic subjects aged between 5 and <19 years. In other words, the natural growth of the eye will be followed without intervention 2. As a paired eye control study anisohyperopes aged between 8 and <16 years will be fitted with a centre-near multifocal design contact lens in their more hyperopic eye and a single vision contact lens in the fellow eye if required. The progression of axial eye growth and refractive error will be measured and compared 3. Subjects aged between 8 and <16 years with similar levels of hyperopia in each eye will be fitted with centre-near multifocal design contact lenses in each eye. The progression of axial eye growth and refractive error will be measured and compared to subjects in the natural progression study. The objectives of the study are to: • Understand the natural progression of axial eye growth and refractive error in hyperopes and anisohyperopes • Establish if axial eye growth and refractive error can be modified using centre-near multifocal design contact lenses in hyperopes and anisohyperopes to improve visual outcome.
Background: Breast cancer (BC) is the most common cancer among women and radiotherapy (RT) plays a major role in its treatment. However, BC RT can lead to incidental irradiation of the heart, resultin...
Background: Breast cancer (BC) is the most common cancer among women and radiotherapy (RT) plays a major role in its treatment. However, BC RT can lead to incidental irradiation of the heart, resulting in an increased risk of a variety of heart diseases arising many years after radiotherapy. Therefore, identifying BC patients with the highest-risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy ageing. There is still a need of precise knowledge on the relationship between radiation dose to specific cardiac structures and early subclinical cardiac changes and their occurrence in time that could finally lead to cardiac complications. Objective: The MEDIRAD EARLY HEART study aims to identify and validate new cardiac imaging and circulating biomarkers of radiation-induced cardiovascular changes arising in the first 2 years after BC RT and to develop risk models integrating these biomarkers combined with precise dose metrics of cardiac structures based on 3D-dosimetry. Methods: EARLY HEART study is a multicenter prospective cohort study that will include 250 women treated for breast cancer and followed for 2 years after RT. Women treated with RT without chemotherapy, for a unilateral breast cancer and aged 40 to 75 years meet the inclusion criteria. Baseline and follow-up data include cardiac measurements based on 2D-speckle-tracking-echocardiography, on coronary computed tomography angiography, on cardiac magnetic resonance imaging and a wide panel of circulating biomarkers of cardiac injury. The absorbed dose is evaluated globally for the heart and different substructures. Dose-response relationship will allow modeling radiation-induced occurrence and evolution of subclinical cardiac lesions and biomarkers in order to develop prediction models. Results: The article details the protocol of the MEDIRAD EARLY HEART study, and presents main limits and advantages of this international project. Inclusion of patients began in August 2017. Preliminary results are expected to be published in 2019, and complete analysis should be published in 2021. Conclusions: The MEDIRAD EARLY HEART study will allow identifying the main cardiac imaging and blood-based determinants of radiation-induced cardiac injuries to better propose primary and secondary preventive measures in order to contribute to enhanced patients’ care and quality of life. Clinical Trial: Clinicaltrials.gov NCT03297346 - https://clinicaltrials.gov/ct2/show/NCT03297346
Background: Meta analyses of telemonitoring for patients with heart failure conclude that it can lower the utilization of health services and improve health outcomes compared to the standard of care....
Background: Meta analyses of telemonitoring for patients with heart failure conclude that it can lower the utilization of health services and improve health outcomes compared to the standard of care. A smartphone-based telemonitoring program is being implemented as part of the standard of care at a specialty care clinic for patients with heart failure in Toronto, Canada. Objective: The objectives of this study are to : 1) evaluate the impact of the telemonitoring program on health service utilization, patient health outcomes and their ability to self-care; 2) identify the contextual barriers and facilitators of implementation at the physician and clinic/institution level; 3) describe patient usage patterns to determine adherence and other behaviours in the Medly Program; and 4) evaluate the costs associated with implementation of the telemonitoring program from the perspective of the healthcare system(i.e., public payer), hospital, and patient. Methods: The evaluation will use a mixed method approach. The quantitative component will include a pragmatic pre-test-post-test study design for the impact and cost analyses which will make use of clinical data and questionnaires administered to at least 108 patients at baseline and 6 months. Outcome data will also be collected at 1 month, 12 months, and 24 months to explore the longitudinal impact of the program. In addition, quantitative data related to implementation outcomes and patient usage patterns of the telemonitoring system will be reported. The qualitative component involves an embedded single case study design to identify the contextual factors that influenced the implementation. The implementation evaluation will be completed using semi-structured interviews with clinicians, and other program staff at baseline, 4 months and 12 months after the program start date. Interviews with patients conducted with patients will be triangulated with usage data to explain usage patterns and adherence to the system. Results: The telemonitoring program was launched in August 2016 and patient enrollment is ongoing. Conclusions: The methods described provide an example for conducting comprehensive evaluations of telemonitoring programs. The combination of impact, implementation, and cost evaluations will inform quality improvement of the existing program and will yield insights into the sustainability of smartphone-based telemonitoring programs for heart failure patients within a specialty care settings.
Background: Monitoring of signs and symptoms in bipolar disorder is typically based on regular assessments from patient-clinician interactions. Mobile and wearable technology promises to make monitori...
Background: Monitoring of signs and symptoms in bipolar disorder is typically based on regular assessments from patient-clinician interactions. Mobile and wearable technology promises to make monitoring symptoms in bipolar disorder easier, but little is known about how best to engage individuals with bipolar disorder in monitoring symptoms. Objective: To provide the rationale and protocol for a randomized control trial that investigates engagement strategies for monitoring symptoms of bipolar disorder, including using activity trackers compared to self-reports and reviewing recorded symptoms weekly with an interviewer. Methods: Fifty individuals with bipolar disorder will be recruited from the Prechter Longitudinal Study of Bipolar Disorder at the University of Michigan to participate in a six-week study. Participants will monitor their symptoms through an activity tracker (Fitbit Alta HR) and a smart-phone app designed for this study. In addition to monitoring symptoms, participants have a 50-50 chance of being assigned to an arm that reviews self-reports and activity information weekly. Statistical tests will be performed to test hypotheses that participants adhere to activity tracking significantly more than self-reporting; prefer activity tracking significantly more than self-reporting; and better adhere to both activity tracking and self-reporting when reviewing collected information weekly. Results: Recruitment began in November 2017. The first group of participants began the study in January 2018. Conclusions: The described study aims to establish strategies to engage bipolar individuals in monitoring their symptoms with mobile and wearable technology. Better engagement strategies are expected to aid current efforts in bipolar research and clinical care, from the development of new smart-phone apps to providing the right intervention to the right individual at the right moment. Clinical Trial: ClinicalTrials.gov NCT03358238
Background: The prevalence rates of depressive and anxiety disorders are high in residential aged care settings. Older adults in such settings may be prone to these disorders, because of losses associ...
Background: The prevalence rates of depressive and anxiety disorders are high in residential aged care settings. Older adults in such settings may be prone to these disorders, because of losses associated with transitioning to residential care, uncertainty about the future, as well as a decline in personal autonomy, health, and cognition. Cognitive behavioural therapy (CBT) is efficacious in treating late-life depression and anxiety. However, there remains a dearth of studies examining CBT in residential settings, compared to community settings. Older adults living in residential settings typically have higher care needs than those living in the community. There are no systematic reviews on the content and the delivery characteristics of CBT for older adults living in residential aged care settings. Objective: The aim of this study was to describe the protocol for a systematic review on the characteristics of CBT for depression and/or anxiety for older adults living in residential aged care settings. Methods: The aim of the systematic review was to describe these characteristics of CBT for depression and/or anxiety for older adults living in residential care. This protocol was developed in compliance with the recommendations of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Studies that meet the inclusion criteria will be identified by systematically searching relevant electronic databases, reference lists, and citation indexes. The PRISMA flow chart will be used to record the process of selection. A pilot-tested data collection form will be used to extract and record data from the included studies. Two reviewers will be involved in screening the titles and abstracts of retrieved records, in screening the full-text of potentially relevant reports, and in extracting data. The delivery and the content characteristics of different CBT programs of the included studies, where available, will be summarised in a table. The Downs and Black checklist will be used to assess the methodological quality of the included studies. Results: Systematic searches will commence in April 2018, and data extraction is expected to commence in July 2018. Analyses and writing will take place in October 2018. Conclusions: Limitations of the systematic review will be outlined. Clinical implications for treating late-life depression and/or anxiety, and implications for residential care facilities will be discussed. Clinical Trial: Systematic review registration: PROSPERO CRD 42017080113