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in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available.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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other Names:
  • Sphygmo BP
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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