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 2015: 4.532)
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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Latest Submissions Open for Peer-Review:View All Open Peer Review Articles
Safety, acceptability and use of a telephone application, BlueIce, for young people who self-harm: protocol for an open Phase 1 trial.
Date Submitted: Aug 21, 2016
Open Peer Review Period: Aug 24, 2016 - Sep 7, 2016
Background: Up to 18% of adolescents will engage in an act of self-harm before young adulthood. Of those who self-harm, half will harm more than once. 1 in 8 acts of self-harm result in a presentation...
Background: Up to 18% of adolescents will engage in an act of self-harm before young adulthood. Of those who self-harm, half will harm more than once. 1 in 8 acts of self-harm result in a presentation to hospital with most acts occurring in private. Mobile apps may provide a way of supporting young people at times of distress. Young people are familiar with, and regular users of technology with 90% of young people aged 15 having a smart phone. . Objective: This is a proof of concept study designed to assess the safety, acceptability, feasibility and usability of a telephone app, BlueIce, with young people who are self-harming Methods: In this phase 1 open trial we will evaluate BlueIce, a telephone app developed and co-produced with young people with lived experience of self-harm. BlueIce includes a mood monitoring diary, selection of mood lifting techniques based on cognitive behaviour therapy and dialectical behaviour therapy and direct access to emergency telephone numbers. We will recruit young people (n=20) attending specialist child and adolescent mental health services with a current or past history of self-harm to try BlueIce as an adjunct to their usual care. Questionnaires and interviews will be conducted at baseline, post familiarisation (2 weeks) and at follow-up, 12 weeks after the baseline assessment. We will assess safety, app use, acceptability and feasibility of use within a clinical setting. Results: The study is currently recruiting. Conclusions: This study is the first to evaluate an app developed with young people for young people who self-harm. It will determine whether BlueIce is acceptable, how often it is used and whether it is safe and does not have any unintentional adverse effects. This information will determine whether a feasibility trial to test recruitment, randomisation, retention and appropriate outcome measures should be pursued.
Use of eHealth and provider-based health services by patients with diabetes mellitus: protocol for a cross-sectional study
Date Submitted: Aug 22, 2016
Open Peer Review Period: Aug 23, 2016 - Sep 1, 2016
Background: The prevalence of diabetes and the use of eHealth is increasing. People with diabetes are in need of frequent monitoring and follow-up of health parameters, and eHealth services can be of...
Background: The prevalence of diabetes and the use of eHealth is increasing. People with diabetes are in need of frequent monitoring and follow-up of health parameters, and eHealth services can be of great significance in this regard. However, little is known about the extent to which different kinds of eHealth tools are used, and how the use of eHealth is associated with the use of provider-based health care services among people with diabetes. Objective: The primary objective of this study is to investigate the use of eHealth and its association with the use of provider-based health care services. The secondary objectives include investigations of which eHealth services that are used (apps, searching engines, video services, social media), investigations of the relationship between socio-economic status and the use of different eHealth tools, whether the use of eHealth is discussed in the clinical encounter, and whether it might lead to or prevent doctor visits and referrals. Methods: We will conduct cross-sectional studies based on self-reported questionnaire data from the population-based seventh Tromsø Study. Participants will be diabetic patients aged 40 years and over. According to our estimates, around 1050 participants will be eligible for inclusion. Data will be analysed by descriptive statistics, chi-square tests, and univariable and multivariable logistic regressions. Results: The grant proposal was approved by The Northern Norway Health Authorities November 23, 2015 (HST 1306-16). Recruitment of participants for The Tromsø Study started in 2015 and will continue throughout 2016. The project period for this particular project started July 1, 2016. Conclusions: The project may gain benefits for patients, health care providers, hospitals, and society as a whole. Benefits are related to improvement of prevention services, health, experience of care services, self-management tools and services, organisational structures, a more efficient use of specialist care, allocation of recourses, and a better understanding of how to meet the challenges from the increasing prevalence of diabetes. The project do have a potential of generalisation to other groups with chronic disease.
Supporting the delivery of total knee replacements care for both patients and their clinicians with a mobile app and online tool: study protocol
Background: Total knee replacement (TKR) surgeries have increased in recent years. Exercise programs and other interventions following surgery can facilitate the recovery process. With limited clinici...
Background: Total knee replacement (TKR) surgeries have increased in recent years. Exercise programs and other interventions following surgery can facilitate the recovery process. With limited clinician contact time, patients of TKR have a substantial burden of self-management and limited communication with their care team, thus often fail to implement an effective rehabilitation plan. Objective: We have developed a digital orthopedic rehabilitation platform that comprises a mobile phone application (app), a wearable activity tracker, and a clinical web portal; in order to address the self- management tasks in addition to engaging patients by encouraging adherence to, and completion of rehabilitation. The study will determine the efficacy of the TKR platform in delivering: a) information and assistance to patients in their preparation and recovery from TKR surgery; and b) a portal for clinician care teams (e.g. surgeons and physiotherapists) to remotely support and monitor patient progress. Methods: The study will evaluate the TKR platform through a randomized controlled trial (RCT), conducted at multiple sites in a number of states in Australia, with 262 patients undergoing TKR surgery, and running for 13 months for each patient. Participants will be randomized to either a control group or the intervention group; both receiving usual care as provided by their surgeon or hospital. The intervention group will receive the app and wearable activity tracker in addition to usual care. All participants will be assessed at four different time points over one year (4 weeks before surgery, immediately before surgery, 12 weeks after surgery, and 52 weeks after surgery). The primary outcome measure is the Oxford Knee Score (OKS). Secondary outcome measures include, Quality of Life (SF-36), depression, anxiety and stress (DASS21), self-motivation, self-efficacy , and the level of satisfaction with the knee surgery and care delivery. The study will also collect quantitative usage data related to for all components (app, activity tracker, and portal) of the TKR platform, and qualitative data on the perceptions of the platform as a tool for patients, carers, and clinicians. Finally, an economical evaluation of the impact of the platform will be conducted. Results: N/A Conclusions: The TKR platform is designed to provide flexibility in care delivery, and increased engagement with rehabilitation services. This trial will investigate the efficacy and effectiveness of the platform, service satisfaction and allow us to model the economic benefits of the provision of digital services. Clinical Trial: The trial has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) with number ACTRN12616000504415.
A Remote Feasibility Study Protocol Using A Consumer Wearable Device
Background: As technology increasingly becomes an integral part of everyday life, many individuals are choosing to use wearable technology such as Fitbit to track their daily physical activity and oth...
Background: As technology increasingly becomes an integral part of everyday life, many individuals are choosing to use wearable technology such as Fitbit to track their daily physical activity and other health-related goals. Researchers would benefit from being able to remotely access the physical activity and health data, without meeting face-to-face with participants and avoiding the high cost of providing consumer wearables to participants for the study duration. Objective: The present study will seek to test the feasibility of remotely collecting physical activity and health-related data from participants without ever meeting them face-to-face. Methods: To assess feasibility of the proposed protocol, 30 participants will be recruited on Mechanical Turk Prime (Mturk Prime) and asked to complete a short online questionnaire. They will also be asked to connect their personal Fitbit device to an online third party software system, called Fitabase, which will allow access to 1 month’s retrospective data and 1 month’s prospective data from the date of sign-up. Results: The feasibility of the protocol will be determined at the end of data collection. Conclusions: The present study will test a protocol whereby respondents connect their own personal consumer wearable device to an online data downloading software system, without the need to meet face-to-face with the research team, or provide them with study-owned devices.
Adjuvant Endocrine Therapy in Breast Cancer: A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study): A two-group controlled comparison pilot study
Background: In women with hormone receptor positive (HR+) breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in...
Background: In women with hormone receptor positive (HR+) breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel e-health tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians. Objective: 1) To determine the effectiveness of a patient-specific, real-time e-health alerts delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation. 2) To assess integration of e-health alerts regarding deviations from best practices in administration of AET by cancer care teams. Methods: A prospective, two group controlled comparison pilot study will be conducted at two urban, McGill University-affiliated hospitals, the Royal Victoria Hospital and St. Mary’s Hospital. A minimum of 43 patients per study arm will be enrolled through site-level allocation. Follow-up is 1.5 years. Healthcare professionals at the intervention site will have access to the e-health tool which will report to them in real-time: medical events with known associations to AET discontinuation, AET adherence monitor, and a discontinuation alert. Results: This protocol has been approved and funded by the Canadian Institutes of Health Research. The study will evaluate site-level differences between AET discontinuation and AET adherence, and asses care team actions at the intervention site. Participant enrollment into this project is expected to start September 2016 with primary data to present by June 2018. Conclusions: This study will offer an opportunity to verify the feasibility of integrating an e-health tool that aims to improve the long-term management of the breast cancer in a high-risk population, by allowing more timely intervention to prevent or rapidly address AET discontinuation. Clinical Trial: We submitted our protocol to clinicaltrials.gov on August 16, 2016. We will provide you with the clinical registry number as soon as we receive it.
Feasibility of ecological momentary assessment of daily text messaging social interaction and substance use among young adult sexual minority Black men
Background: Young adult sexual minority Black men bear the greatest burden of new HIV infections among sexual minority men in the United States. Ecological momentary assessment (EMA) methods, such as...
Background: Young adult sexual minority Black men bear the greatest burden of new HIV infections among sexual minority men in the United States. Ecological momentary assessment (EMA) methods, such as short message service (SMS) texting, may serve as a viable counterpart to retrospective evaluation methods by using real-time data collection to assess behaviors as they occur in the environment. Limited research has focused on the use of EMA among young adult sexual minority Black men. Objective: The objective of this pilot study was to assess the feasibility of using text messaging as a method of EMA to examine daily text messaging social interaction and substance use behaviors among young adult sexual minority Black men. Methods: Participants were recruited through flyers and snowball sampling during the spring and summer of 2015 at a community-based organization in Washington, DC, serving sexual minority men. Eligible participants were enrolled in a one-time in-person study visit that consisted of: informed written consent to participate in the study, a self-administered survey, a semi-structured qualitative interview and enrollment and training in EMA data collection. The day after the study visit, a random prompt survey consisting of eight questions was texted to participants on their personal cell phones three times a day over a 14-day data collection period assessing mood, social interaction via text messaging and substance use. Results: EMA feasibility was tested with 25 participants between the ages of 21 to 25 (M=23.48, SD=1.5). There were 104 total days of EMA observation and the retention rate was 72%. Participants responded to the random prompt surveys with a 57.3% survey compliance rate, providing a total of 544 completed surveys. The overall mean response time to complete a survey was 6.1 minutes. Conclusions: The use of an EMA protocol in this relatively underrepresented and understudied population has the potential to be a very useful research tool for future studies. This pilot study demonstrated that young adult sexual minority Black men are willing to participate in health, technology and innovation research and use text messaging to report their behavior. Additional research is needed on how to increase survey compliance.