JMIR Research Protocols
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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The importance of trust in the adoption and use of intelligent assistive technology by older adults to support aging in place: A scoping review
Background: Background: Intelligent assistive technologies that complement and extend human abilities have proliferated in recent years. Service robots, home automation equipment, and other digital as...
Background: Background: Intelligent assistive technologies that complement and extend human abilities have proliferated in recent years. Service robots, home automation equipment, and other digital assistant devices possessing artificial intelligence are forms of assistive technologies that have become popular in society. Older adults (≥55 years in age) have been identified by industry, government, and researchers as a demographic who can benefit significantly from the use of intelligent assistive technology to support various activities of daily living. Objective: Objective: The purpose of this scoping review is to synthesize the literature on the importance of the concept of ‘trust’ in the adoption of intelligent assistive technologies to assist aging in place by older adults. Methods: Methods: Using a scoping review methodology, our search strategy will examine the following databases: ACM Digital Library, CINAHL, Medline, Scopus, and Web of Science. Two reviewers (AM, JL) will independently screen the initial titles obtained from the search, and these results will be further inspected by other members (RB, JM) of the research team for inclusion into the review. Results: Results: This review will provide insights into how the concept of trust is actualized in the adoption of intelligent assistive technology by older adults. Preliminary sensitization to the literature suggests that the concept of trust is fluid, non-stable, and intimately tied to the sort of intelligent assistive technology being examined. Further, a wide range of theoretical lens that include elements of trust have been used to examine this concept. Conclusions: Conclusions: This review will describe the concept of trust in the adoption of intelligent assistive technology by older adults, and will provide insights for practitioners, policy makers, and technology vendors for future practice.
A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
Background: Rheumatoid arthritis (RA) flares have a profound effect on patients, causing pain and disability. However, flares often occur between regularly scheduled healthcare provider (HCP) visits a...
Background: Rheumatoid arthritis (RA) flares have a profound effect on patients, causing pain and disability. However, flares often occur between regularly scheduled healthcare provider (HCP) visits and are, therefore, difficult to monitor and manage. We sought to develop a smartphone application (app) combined with a population management system to help track RA flares between visits. Objective: The objective of this study is to implement a smartphone app + population management system to monitor RA disease activity between scheduled HCP visits over a period of 6-months. Methods: This is a randomized controlled trial that lasts for 6 months for each participant. We aim to recruit 190 patients, randomized 50:50 to the intervention group vs. the control group. The intervention group will be assigned the smartphone app and be prompted to answer daily questionnaires sent to their smartphones. Both groups will be assigned a population manager, who will check in with participants via telephone at 6-weeks and 18-weeks. The population manager will also communicate with participants in the intervention group if/when their responses indicate a sustained increase in RA disease activity. To assess patient satisfaction, the primary outcomes will be scores on the Treatment Satisfaction Questionnaire for Medication (TSQM) and Perceived Efficacy in Patient-Physician Interactions (PEPPI) questionnaire at 6 months. To determine the effect of the smartphone app on RA disease activity, the primary outcome will be the Clinical Disease Activity Index (CDAI) at 6 months. Results: The trial started in November 2016, and an estimated 2.5 years will be necessary to complete the study. Study results are expected to be published by the end of 2019. Conclusions: The completion of this study will provide important data regarding: 1) the assessment of validated outcome measures to assess RA disease activity with a smartphone app between routinely scheduled HCP visits, 2) patient engagement in monitoring their condition, and 3) communication between patients and HCPs through a population management system. Clinical Trial: NCT02822521
Testing the MD-Link, a low cost mobile electrocardiography (ECG) monitoring device, in patients with cardiovascular diseases: study protocol
Background: Having mobile devices that provide patients with the ability to record and monitor the electrical activity of their hearts enhances patient self-care and the early detection of cardiac arr...
Background: Having mobile devices that provide patients with the ability to record and monitor the electrical activity of their hearts enhances patient self-care and the early detection of cardiac arrhythmia (irregular heartbeat), yet few such devices exist in Vietnam. Challenges exist for introducing mobile electrocardiography (ECG) monitoring devices in Vietnam, including patient accessibility and affordability. A low cost mobile electrocardiography monitoring device designed and developed in Vietnam, that allows patients to easily measure their heart’s electrical activity and navigate recordings may be a solution. Objective: The aim of this project is to assess the usability of a newly developed mobile ECG device, MD-Link, through the comparison of its outputs to the standard printed outputs from a 12-lead electrocardiogram, the Nihon Kohden Cardiofax S Electrocardiograph Model ECG-1250K. Methods: We will conduct this study in two stages: measurement of the ECG signals of patients using the MD-Link and the Nihon Kohden Cardiofax S, and analysis of the selected standard outputs collected from the ECG recordings of the MD-Link and the Nihon Kohden Cardiofax S. The MD-Link consists of (1) a mobile device (e.g. a smartphone), (2) two active dry electrodes as ECG touch sensors enabling convenient recording of ECG signals, and (3) an easy-to-use mobile application interface enabling the upload and accurate display of ECG recordings to patients and their clinicians. Our research team consisting of members from Dartmouth College, the Institute of Health, Population and Development (PHAD), Hanoi University of Science and Technology (HUST), and physicians and nurses from International Clinics Thanh Chan will assist in carrying out this project. Results: We will proceed with a publication plan that includes a project report and ultimately articles for peer-reviewed journals. We also hope to disseminate our work at relevant conferences to provide more coverage and exposure to the MD-Link mobile device. Conclusions: At the end of this project, we will have developed and tested the MD-Link, a low cost mobile ECG monitoring device with some supportive comparisons to standard ECG devices commonly used in heart clinics or hospitals in Vietnam. Our long-term goal is for the MD-Link to be easily accessible, affordable and to fit into a patient’s daily routine, thus increasing the levels of patient cardiovascular health.
Protocol Psychometric evaluation of a patient-reported Symptom Index for non-muscle invasive bladder cancer: field testing
Date Submitted: Aug 16, 2017
Open Peer Review Period: Aug 17, 2017 - Aug 31, 2017
Background: Non-Muscle Invasive Bladder Cancer (NMIBC) is a chronic condition requiring intensive follow-up, repeated endoscopic examinations, tumour resections and intravesical treatments that can be...
Background: Non-Muscle Invasive Bladder Cancer (NMIBC) is a chronic condition requiring intensive follow-up, repeated endoscopic examinations, tumour resections and intravesical treatments that can be 3-monthly and life-long. In this clinical context, patient-reported outcomes (PROs) are a critical concern for patients and their managing clinicians. PROs have enormous potential to be integral to treatment assessment and recommendations for NMIBC, however, current PRO measures are inadequate for NMIBC because they lack key NMIBC-specific symptoms and side effects associated with contemporary treatments. Objective: The overarching aim of the research is to develop and evaluate a patient-reported Symptom Index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients, reliable, valid and responsive to differences between contemporary treatments for NMIBC, and fit for purpose as an endpoint in clinical trials. Methods: The NMIBC-SI will be evaluated in two field tests. Field test 1 is a cross-sectional study design involving 225 adult NMIBC patients recruited while undergoing active treatment or completed final treatment within the last week. Data collected includes patient demographics, clinical features of the tumour, risk category, treatment type, comorbidity and PROs. Field test 2 is a prospective longitudinal study involving 225 newly diagnosed NMIBC-SI patients. Clinical data and patient-completed questionnaires will be collected at four time-points during treatment: before tumour resection; 1-week after resection; end of induction intravesical therapy; and 1-year follow-up. Standard psychometric tests will be performed to assess the reliability, validity, responsiveness, and clinical utility of the NMIBC-SI. Results: Participant recruitment to Field Test 1 commenced in February 2017. Field Test 2 is planned to commence January 2018. Final results are expected to be published in 2019. The NMIBC-SI will be freely available for use via registration. Conclusions: This study protocol contains detailed methods that will be used across multiple international sites. Phase 2 in the development of the NMIBC-SI will enable a comprehensive evaluation of its reliability, validity and responsiveness to ensure that the NMIBC-SI is fit for purpose in clinical research, and provide an evidence-base for the on-going improvement of future therapies for NMIBC. Clinical Trial: ClinicalTrials.gov registration ID: NCT03091764
A tailored advice tool for skiers and snowboarders: design of a randomized controlled trial
Background Being active in sports has many positive health effects. The direct effects of engaging in regular physical activity are particularly apparent in the prevention of several chronic diseases...
Background Being active in sports has many positive health effects. The direct effects of engaging in regular physical activity are particularly apparent in the prevention of several chronic diseases, including: cardiovascular disease, diabetes, cancer, hypertension, obesity, depression and osteoporosis. Besides the beneficial health effects of being active, sports participation is unfortunately also associated with a risk for injuries. In many sports injury, e.g. winter sports, preventive measures are not compulsory. Therefore, a behavioral change in sports participants is necessary to increase the use of effective measures and subsequently prevent or reduce injuries in sports. The evidence-based intervention ‘Wintersportklaar’ is developed to stimulate injury preventive behavior among skiers and snowboarders. In this article the design of the effectiveness study will be described. Methods A randomized controlled trial with a follow-up period of 4 months during the winter sport season will be conducted. The participants consist of unexperienced skiers and snowboarders. At baseline, skiers and snowboarders in the intervention and control group are asked to report the injury preventive measures they usually take during their preparation to their winter sport holiday. One and three months after baseline, skiers and snowboarders are asked to report retrospectively in detail what they have done regarding injury prevention during their current winter sport preparation and winter sport holiday. Descriptive analyses (mean, standard deviation, frequency, range) are conducted for the different baseline variables in both study groups. To evaluate the success of the randomization, baseline values are analyzed for differences between the intervention and control group (Chi Square, independent T-tests and/or Mann-Whitney test). Chi square tests and/or logistic regression analyses are used to analyze behavioral change according to the intention to treat principle. Discussion To conquer the negative side effects of sports participation, the use of injury preventive measures is desirable. As the use of injury prevention is mostly not compulsory in skiing and snowboarding , a behavioral change is necessary to increase the use of effective injury preventive measures in winter sports. Trial Registration NTR6233
Telegerontology as a Novel Approach to Optimize Health and Safety among Rural Community-Dwelling Canadians with Dementia: Study Protocol for a Randomized Controlled Trial
Date Submitted: Aug 14, 2017
Open Peer Review Period: Aug 15, 2017 - Aug 29, 2017
Background: Telegerontology is an approach using videoconferencing to connect an interdisciplinary team in a regional specialty center to patients in rural communities, which is becoming increasingly...
Background: Telegerontology is an approach using videoconferencing to connect an interdisciplinary team in a regional specialty center to patients in rural communities, which is becoming increasingly practical for addressing current limitations in rural community-based dementia care. Objective: Using the remotely-delivered expertise of the Telegerontology dementia care team, we aim to enhance the caregiver/patient/physician triad and thereby provide the necessary support for the person with dementia to ‘age in place’. Methods: This is a cluster randomized controlled trial with four rural regions in the province of Newfoundland and Labrador, Canada (2 regions randomly assigned to “intervention” and 2 to “control”). The study population included 22 “dementia triads” that consist of a community-dwelling older Canadian with moderate to late dementia, their family caregivers, and their Primary Care Physician (PCP). Over the 6 month active study period, all participants will be provided an iPad. The intervention is intended as an adjunct to existing PCP care, consisting of weekly Skype-based videoconferencing calls with the Telegerontology physician, and other team members as needed (occupational therapist, physical therapist etc.). Control participants receive usual community-based dementia care with their PCP. A baseline (pre-) assessment will be performed during a home visit with the study team. Post intervention, 12 and 18 month follow up assessments will be collected remotely using specialized dementia monitoring applications and Skype calls. Primary outcomes include admission to Long Term Care, falls, emergency room visits, hospital stays, and caregiver burden. Results: Results will be available in the fall of 2017. Conclusions: Results from this study will demonstrate a novel approach to dementia care that has the potential to impact both rural PCPs, family caregivers, and people with dementia; as well as provide evidence for the utility of Telegerontology in models of e-health-based care. Clinical Trial: N/A