- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528654
A Web-based Platform to Conduct Trials of mHealth Apps for Hypertension
April 5, 2022 updated by: McMaster University
Feasibility of a Web-based Platform to Conduct RCTs of mHealth Apps for CV Risk Factors: Trial My App Hypertension RCT
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in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available.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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L2X2
- Hamilton Health Sciences
-
Hamilton, Ontario, Canada, L8S4L8
- McMaster University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention App Group
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.
|
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.
Other Names:
|
NO_INTERVENTION: Educational Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participation completion
Time Frame: 6-months
|
Proportion of registered participants who successfully complete the 6-month questionnaire
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline blood pressure at 6 months
Time Frame: Baseline, 6-months
|
Statistically significant difference in mean change in systolic BP measurements [defined as P<0.05 using a Pearson test] compared to standard ranges from baseline to six months between groups.
|
Baseline, 6-months
|
Change from baseline self-management adherence at 6 months
Time Frame: Baseline, 6-months
|
Differences in mean change to adherence to hypertension self-care behaviors.
This will be scored using the H-SCALE.
|
Baseline, 6-months
|
Change from baseline healthcare self-efficacy at 6 months
Time Frame: Baseline, 6-months
|
Differences in mean change to healthcare self-efficacy.
This will be scored using the frequency distribution and mean of the Health Confidence Score, a 4-item Likert scale.
|
Baseline, 6-months
|
Change from baseline patient-reported outcomes at 6 months
Time Frame: Baseline, 6-months
|
Descriptive analysis of patient-oriented experiences between groups measured in a 5-point Likert scale questionnaire developed from advisory board themes at 95% confidence interval (CI)
|
Baseline, 6-months
|
Eligibility rate
Time Frame: Baseline
|
The number of patients meeting eligibility criteria in baseline and screening questionnaires.
|
Baseline
|
Consent rate
Time Frame: Baseline
|
The proportion of eligible participants consenting to participating in the trial with an electronically signed consent form.
|
Baseline
|
Retention rate
Time Frame: 6-months
|
The proportion of withdrawals and drop-outs post-recruitment.
|
6-months
|
Outcome acceptability
Time Frame: 6-months
|
Proportion of questionnaires completed and submitted
|
6-months
|
Appropriateness of data collection processes
Time Frame: 6-months
|
Completeness and accuracy of data in each questionnaire
|
6-months
|
Recruitment rate
Time Frame: Baseline
|
The number of patients successfully recruited to the platform
|
Baseline
|
Change from baseline intervention acceptability at 6 months
Time Frame: Baseline, 6-months
|
Frequency of app usage between control and intervention groups based on answers to questionnaires
|
Baseline, 6-months
|
Concordance of self-reported blood pressure
Time Frame: 6-months
|
Concordance between self-reported blood pressure readings and in-person collected data
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Cynthia Lokker, PhD, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 28, 2021
Primary Completion (ACTUAL)
December 9, 2021
Study Completion (ACTUAL)
December 9, 2021
Study Registration Dates
First Submitted
August 19, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (ACTUAL)
August 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 13, 2022
Last Update Submitted That Met QC Criteria
April 5, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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