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A Web-based Platform to Conduct Trials of mHealth Apps for Hypertension

NCT04528654 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-04-13

No results posted yet for this study

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in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available.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.

Conditions

Interventions

OTHER

Mobile Health Application

The participants will be given instructions to use their smartphone or tablet to download the hypertension tracking app. They will follow the instructions provided within the app and use it to track their blood pressure over the next six months.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McMaster University

    lead OTHER

Principal Investigators

  • Cynthia Lokker, PhD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2021-12-09
Completion
2021-12-09

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04528654 on ClinicalTrials.gov