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Cardiovascular Risk FactorNCT04528654

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

A study testing Mobile Health Application in people with Cardiovascular Risk Factor and Hypertension, run by McMaster University at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Risk Factor, Hypertension
What is being tested?
Mobile Health Application
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
2 sitesCanada
Study dates
28 Apr 2021to 9 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L2X2

  • McMaster University

    Hamilton, Ontario, L8S4L8

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Mobile Health Application
Keywords
mobile health, mhealth
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile Health ApplicationOther

    Also called Sphygmo BP

    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.

Study groups in NCT04528654
Study groupRoleWhat they receive
Intervention App GroupExperimentalThe 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.
Receives: Other: Mobile Health Application
Educational Control GroupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Participation completion

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

    Measured: 6-months

Secondary outcomes (12)

  1. Change from baseline blood pressure at 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.

    Measured: Baseline, 6-months

  2. Change from baseline self-management adherence at 6 months

    Differences in mean change to adherence to hypertension self-care behaviors. This will be scored using the H-SCALE.

    Measured: Baseline, 6-months

  3. Change from baseline healthcare self-efficacy at 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.

    Measured: Baseline, 6-months

  4. Change from baseline patient-reported outcomes at 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)

    Measured: Baseline, 6-months

  5. Eligibility rate

    The number of patients meeting eligibility criteria in baseline and screening questionnaires.

    Measured: Baseline

  6. Consent rate

    The proportion of eligible participants consenting to participating in the trial with an electronically signed consent form.

    Measured: Baseline

  7. Retention rate

    The proportion of withdrawals and drop-outs post-recruitment.

    Measured: 6-months

  8. Outcome acceptability

    Proportion of questionnaires completed and submitted

    Measured: 6-months

  9. Appropriateness of data collection processes

    Completeness and accuracy of data in each questionnaire

    Measured: 6-months

  10. Recruitment rate

    The number of patients successfully recruited to the platform

    Measured: Baseline

  11. Change from baseline intervention acceptability at 6 months

    Frequency of app usage between control and intervention groups based on answers to questionnaires

    Measured: Baseline, 6-months

  12. Concordance of self-reported blood pressure

    Concordance between self-reported blood pressure readings and in-person collected data

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2020
  2. Study start28 Apr 2021
  3. Primary completion9 Dec 2021
  4. Study completion9 Dec 2021

Why it stopped: Challenges in recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04528654
Sponsor's protocol ID
8039
Status last verified
Apr 2022
First submitted
19 Aug 2020
Last updated
13 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data (IPD) available to other researchers.

Publications

  • 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.

    PubMed 33522978

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Health Application in people with Cardiovascular Risk Factor and Hypertension, run by McMaster University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Challenges in recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participation completion (time frame: 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04528654, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.

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