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

NCT04528654 | Terminated

• 1 other identifier: 8039
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available.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

Conditions

Cardiovascular Risk Factor; Hypertension

Keywords

mobile health; mhealth

Outcome Measures

Primary Outcomes (1)

• Participation completion

  Proportion of registered participants who successfully complete the 6-month questionnaire

  6-months

Secondary Outcomes (12)

• Change from baseline blood pressure at 6 months

  Baseline, 6-months

• Change from baseline self-management adherence at 6 months

  Baseline, 6-months

• Change from baseline healthcare self-efficacy at 6 months

  Baseline, 6-months

• Change from baseline patient-reported outcomes at 6 months

  Baseline, 6-months

• Eligibility rate

  Baseline

Study Arms (2)

Intervention App Group

EXPERIMENTAL

The intervention group will be instructed to download the chosen hypertension mobile health app (Sphygmo BP) via a link provided on the platform. The hypertension app has blood pressure tracking and monitoring features and they are instructed to use the app. They will also receive a link to the Heart and Stroke foundation website which includes information on hypertension management and measuring blood pressure.

Other: Mobile Health Application

Educational Control Group

NO INTERVENTION

The control will comprise usual care including any anti-hypertensive medication and lifestyle changes, and the link to the Heart and Stroke Foundation website which includes information on hypertension management and measuring blood pressure.

Interventions

Mobile Health Application OTHER

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.

Also known as: Sphygmo BP

Intervention App Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Hamilton Health Sciences

Hamilton, Ontario, L8L2X2, Canada

Location

McMaster University

Hamilton, Ontario, L8S4L8, Canada

Location

Related Publications (1)

• 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.

  PMID: 33522978 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cynthia Lokker, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are unblinded. Participants will know if they were assigned to the intervention or control group
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 27, 2020
• Study Start: April 28, 2021
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)