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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: 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
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Background: The absence of information on reproductive cancer in Black men in South Africa creates a knowledge gap about health outcomes. Consequently, it is necessary to map the existing information...
Background: The absence of information on reproductive cancer in Black men in South Africa creates a knowledge gap about health outcomes. Consequently, it is necessary to map the existing information in order to formulate research that addresses the knowledge gap. To establish the range, nature and extent of published research on reproductive cancer in Black men in South Africa, an intensive scoping literature search has been designed. Methods: This study is a rigorous scoping review, conducted by five researchers and intends to explore and uncover the depths of existing research and identify research gaps. The literature search is conducted through online databases and policy documents. The process includes title, abstract and paper review and data abstraction, as espoused by Arksey and O’Malley (2005). Data is analysed using critical thematic analysis. This is mostly a web-based search no human subjects are to be used and does not require obtaining ethics clearance. Discussion: no other scoping or systematic review have been conducted on this topic from the continent. Therefore there is no coherent evidence that indicates the research gaps for future research on reproductive cancer for Black men. The proposed scoping review is necessary to advance science borne of a systematic approach. This scoping protocol outlines the methodology for critical literature appraisal to identify the topics in literature on Black men with reproductive cancer and possibly point out to new areas of research gaps. Conclusion: This protocol is sufficient for the purposes of this study and contributes meaningfully to research on male reproductive cancers in South Africa. This protocol also provides an audit trial to ensure scientific rigour and reproducibility of the research findings
Introduction: A Cardiogenic Shock initiative focused on increased disease awareness, early multidisciplinary team activation, rapid initiation of mechanical circulatory support, and hemodynamic-guided...
Introduction: A Cardiogenic Shock initiative focused on increased disease awareness, early multidisciplinary team activation, rapid initiation of mechanical circulatory support, and hemodynamic-guided management and improvement of outcomes in cardiogenic shock. Objectives: • To collect retrospective clinical outcomes for acute decompensated heart failure cardiogenic shock and acute myocardial infarction cardiogenic shock, and compare current versus historical survival rates and clinical outcomes. • Evaluate Inova Heart and Vascular Institute (IHVI) site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017. • To compare outcomes related to early implementation of mechanical circulatory support and hemodynamic-guided management versus historical controls. • Assess survival to discharge rate, and 30 day survival rate in patients receiving intervention from the designated shock team. • Create a clinical archive of Cardiogenic Shock patient characteristics for future analysis and the support of translational research studies. Methods: Retrospective and prospective data will be collected in patients cared for at IHVI with documented cardiogenic shock as a result of acute decompensated heart failure or acute myocardial infarction. This registry will include data in patients prior to and after the initiation of the multidisciplinary Cardiogenic Shock Team on January 1, 2017. Clinical outcomes associated with early multidisciplinary team intervention will be analyzed. 142 patient were identified with two readmissions. Of 140 patients 123 met inclusion criteria. The remaining patients demonstrated 63 % survival to discharge rate, exceeding the historical norms of 45- 50%. Early intervention by a multidisciplinary team improves survival and quality of life in the clinically complex cardiogenic shock population. Clinical Trials: NCT03378739
Background: There is a significant revolving door of incarceration among homeless adults. Homeless adults who receive the professional coordination of individualized care (i.e., case management) durin...
Background: There is a significant revolving door of incarceration among homeless adults. Homeless adults who receive the professional coordination of individualized care (i.e., case management) during the period following their release from jail experience fewer mental health and substance use problems, are more likely to obtain stable housing, and are less likely to be re-incarcerated. This is because case managers work to meet the various needs of their clients by helping them to overcome barriers to needed services (e.g., food, clothing, housing, job training, substance abuse and mental health treatment, medical care, medication, social support, proof of identification, legal aid). Many barriers (e.g., limited transportation, inability to schedule appointments, limited knowledge of available services) prevent homeless adults who were recently released from incarceration from obtaining available case management, crisis management, substance abuse, and mental health services. Objective: The Link2Care study will assess the effectiveness of a smart phone application for increasing case management and treatment service utilization, and in turn reducing homelessness and re-arrest. The goals of this research are to: 1) assess the impact of an innovative smart phone application that will prompt and directly link recently incarcerated homeless adults to community-based case management services and resources, and 2) utilize in-person and smart phone-based assessments to identify key variables (e.g., alcohol/drug use, social support, psychological distress, quality of life) that predict continued homelessness and re-arrest. Methods: Homeless adults (N=432) who enroll in a shelter based Homeless Recovery Program after release from the Dallas County Jail will be randomly assigned to one of three treatment groups: 1) usual shelter-based case management (UCM), 2) UCM plus a study provided smart phone (UCM+SP), and 3) UCM with a study-provided smart phone that is preloaded with an innovative case management app (SPCM). Those assigned to SPCM receive smart phones that prompt (twice weekly) connections to shelter-based case managers. The app will also offer direct links to case managers (available during normal business hours) and crisis interventionists (available 24 hours a day, 7 days a week), with the touch of a button. Results: Recruitment is expected to begin in the spring of 2018, and the study will conclude in 2021. Conclusions: This research represents an important step toward integrated service connection and healthcare service provision for one of the most underserved, high need, and understudied populations in the U.S. Clinical Trial: NCT03399500
Background: While nutrition is a widely accepted tool for the prevention of long-term health conditions, current approaches have not adequately reduced chronic disease morbidity. Nutrigenomics has gre...
Background: While nutrition is a widely accepted tool for the prevention of long-term health conditions, current approaches have not adequately reduced chronic disease morbidity. Nutrigenomics has great potential, however, it is complicated to implement. There is a need for products based on nutrition-related gene test results which are easily understood, accessible and utilized. Objective: The primary objective of this study is to compare the efficacy of a non-practitioner assisted direct-to-consumer (DTC) self-driven approach to nutrigenomics versus a personalized practitioner-led method. The secondary aims are to use this data combined with participant feedback to generate more effective nutrigenomics-based products. Methods: This 4-month study used a mixed-methods design that included: 1) a phase 1 randomized control trial that examined the effectiveness of a multi-faceted, nutrition-based gene test (components assessed included the major nutrients, food tolerances, food taste and preferences, and vitamins) in changing health behaviours; followed by 2) qualitative investigation that explored participants’ experiences. The study recruited 55 healthy males and females (35-55 years) randomized as a 2:1 ratio where 36 received the intervention (gene-test results plus personalized nutrition report) and 19 were assigned to the control group (gene-test results report emailed). Both groups received follow-up emails with nutrition-related tips and reminders. The primary outcomes of interest measures included changes in diet (nutrients, healthy eating index), self-efficacy, quality of life and anthropometrics (BMI, waist:hip) measured at baseline, post-intervention (3 and 6 weeks), and the final visit. After the study has been completed, participants in the control group will also receive their personalized nutrition report. Results: To date, only three participants have dropped out due to reasons such as not completing all required data collection forms or they were later found to be ineligible (retention of 95% of participants). Most participants are female, married, and had post-secondary education. Conclusions: This study will leverage quantitative and qualitative findings, which will guide the development of nutrigenomics-based products in electronic formats that are user-friendly for consumers and health professionals. While the quantitative data have not been analyzed yet, the overwhelming interest in the study and the extremely high retention rate exhibit a great degree of interest in this field, and a definite need for further studies. Clinical Trial: The study protocol is registered with U.S. National Library of Medicine (www.clinicaltrials.gov; Trial registration #NCT03310814).