Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 5, 2021
Open Peer Review Period: Nov 30, 2020 - Jan 8, 2021
Date Accepted: Jan 8, 2021
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Feasibility of a web-based platform to efficiently conduct RCTs of mHealth apps for CV risk factors: Protocol for the Trial My App hypertension RCT
ABSTRACT
Background:
Mobile health (mHealth) interventions can improve health by improving cardiovascular (CV) risk factors, but their adoption in care by physicians and patients is untapped. Few mHealth applications (apps) have been evaluated in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available. Given the rapid pace of change in this field, it is not feasible to rigorously evaluate mHealth apps with current methodologies.
Objective:
The overall aim of this pilot study is to test the feasibility of using a web research platform called Trial My App (TMA) to conduct efficient and rigorous online randomized controlled trials (RCTs) of mHealth apps relevant to patients with CV risk factors, by evaluating an app that targets hypertension.
Methods:
200 participants with sub-optimally controlled hypertension will be recruited through advertisements in newsletters, media, and the Internet, as well as through referrals from their healthcare providers. Screening, consent, randomization, and collection of patient-important health confidence and self-management ability outcomes will be conducted online through the TMA research platform. Participants will be randomized into 2 groups: 100 that will use an mHealth app for tracking hypertension and 100 to an educational control. All participants will complete questionnaires at 0, 1, 3 and 6 months after enrolment. A sub-study to validate the method of blood pressure readings and the consistency of data entered through TMA will be conducted with 40 participants.
Results:
The primary outcomes of the study include the feasibility of conducting an RCT using the TMA platform by reporting recruitment, retention, and completion statistics. We will validate app-entered data with a standard 7-day home blood pressure measurement method. Lastly, the pilot, non-blinded RCT will assess the effectiveness of an mHealth app for improving control of hypertension compared with an educational control group.
Conclusions:
The current study will determine if it is feasible to use the TMA web-based platform to evaluate the effectiveness of mHealth apps for patients with CV risk factors. As more mHealth apps are evaluated in RCTs, patients will be able to select apps that meet their needs and physicians will be able to make evidence-based recommendations to their patients for apps aimed at improving CV health. Clinical Trial: ClinicalTrials.gov NCT04528654; https://clinicaltrials.gov/ct2/show/NCT04528654
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