Clinical trial NCT04528654: A Web-based Platform to Conduct Trials of mHealth Apps for Hypertension
Official title: Feasibility of a Web-based Platform to Conduct RCTs of mHealth Apps for CV Risk Factors: Trial My App Hypertension RCT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Risk Factor
Hypertension
Keywords: mobile health
mhealth
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-08-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized using a web-based blocked randomization list and a 1:1 allocation ratio to one of two possible groups, an intervention group or an educational control group.
Primary purpose: OTHER

Brief summary: Self-management of cardiovascular (CV) risk factors is a recommended form of secondary disease prevention. There are thousands of consumer-facing mobile health (mHealth) applications (apps) intended for tracking, monitoring, and communicating risk factors and health conditions such as hypertension. mHealth apps may be beneficial in improving health status and reducing risk factors. However, the majority of mHealth apps available for consumers have not been scientifically and rigorously 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in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available.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. McMaster University Health Information Research Unit has developed an innovative research approach using a web-based platform, called Trial My App (TMA), designed to perform efficient, cheap, but high-quality testing of apps relevant to patients with CV risk factors. The overall aim of this pilot study is to test the feasibility of using the web research platform to conduct efficient and rigorous online randomized controlled trials (RCTs) of mHealth apps relevant to patients with CV risk factors. Screening, consent, randomization, and collection of outcomes are completed online using the TMA platform. Recruitment, retention, and completion statistics will be collected in this pilot trial evaluating an mHealth app that targets hypertension. The investigators will partner with clinics in the community to recruit patients to the platform. Study findings will determine if it is feasible to use the relatively simple TMA web-based approach to evaluating the clinical efficacy of mHealth apps for patients with CV risk factors.

Detailed description: The purpose of this study is to test the feasibility of the newly developed Trial My App platform to conduct an efficient RCT of an mHealth app that targets hypertension, a CV risk factor, without the need for in-person visits. Trial stages, including screening, consent, randomization, and collection of patient-important outcomes, will be performed virtually using the TMA platform. A combination of passive and active recruitment will begin in fall 2020 after ethics approval. A variety of recruitment materials will be distributed by a research assistant to partner newsletters, websites, community practices and primary care or speciality clinic waiting rooms. These materials include videos, paper and online posters/postcards, emails, as well as posts advertising on social media. Social media recruitment will consist of general posts and targeted ads. The primary goal at this stage is to determine whether TMA, the innovative, efficient, web-based methodology, can be used to conduct RCTs evaluating mHealth interventions. The primary feasibility outcome is study completion. Other feasibility outcomes are recruitment rate, eligibility rates, consent rates, retention rates, intervention adherence, and appropriateness of data collection processes. Descriptive analysis will be performed on the dataset using appropriate statistical methods. The secondary objective is to test the clinical efficacy of the chosen mHealth app in reducing BP in patients with sub-optimally controlled hypertension when compared with an educational control group. Efficacy outcomes include clinical assessment changes, self-management adherence, and patient-reported outcomes. This is a pilot, non-blinded, feasibility RCT, comparing use of a hypertension tracking app versus an education control in participants with hypertension that is sub optimally controlled. The investigators will later include a sub-study to validate the blood pressure data inputted into the online platform through in-person blood pressure measurements. Participants will be asked to register on the TMA site and will complete user profile and screening questionnaires and consent for participation in the pilot trial. The participants that meet inclusion criteria will be asked to electronically consent to take part in the pilot trial, and input clinical and patient-important data at 0, 1, 3, and 6 months into the web application.

Eligibility criteria: Inclusion Criteria

* age over 18
* diagnosis of hypertension
* interested in using an app for hypertension management
* access to a smartphone with internet connection
* access to a blood pressure monitoring device (in home or community setting, e.g., pharmacy)

Exclusion Criteria:

* participant-reported BP within target within the 2 weeks prior to enrolment. Target range for patients with diabetes is systolic BP \<130 mm Hg and diastolic BP \< 80 mm Hg; for those without diabetes, target range is systolic BP \<140 mm Hg and diastolic BP \< 90 mm Hg according to Hypertension Canada guidelines
* emergent hypertensive concerns with systolic BP ≥180 mmHg or diastolic BP ≥120 within the 2 weeks prior to enrolment
* current use of a mobile app for hypertension management
* pregnancy
* not living in Canada
* unwillingness or inability to give informed consent

Primary outcomes:
measure: Participation completion
timeFrame: 6-months
Secondary outcomes:
measure: Change from baseline blood pressure at 6 months
timeFrame: Baseline, 6-months
measure: Change from baseline self-management adherence at 6 months
timeFrame: Baseline, 6-months
measure: Change from baseline healthcare self-efficacy at 6 months
timeFrame: Baseline, 6-months
measure: Change from baseline patient-reported outcomes at 6 months
timeFrame: Baseline, 6-months
measure: Eligibility rate
timeFrame: Baseline
measure: Consent rate
timeFrame: Baseline
measure: Retention rate
timeFrame: 6-months
measure: Outcome acceptability
timeFrame: 6-months
measure: Appropriateness of data collection processes
timeFrame: 6-months
measure: Recruitment rate
timeFrame: Baseline
measure: Change from baseline intervention acceptability at 6 months
timeFrame: Baseline, 6-months
measure: Concordance of self-reported blood pressure
timeFrame: 6-months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Cynthia Lokker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lokker C, Jezrawi R, Gabizon I, Varughese J, Brown M, Trottier D, Alvarez E, Schwalm JD, McGillion M, Ma J, Bhagirath V. Feasibility of a Web-Based Platform (Trial My App) to Efficiently Conduct Randomized Controlled Trials of mHealth Apps For Patients With Cardiovascular Risk Factors: Protocol For Evaluating an mHealth App for Hypertension. JMIR Res Protoc. 2021 Feb 1;10(2):e26155. doi: 10.2196/26155.