Mobile Health App for Cardiovascular Disease

(ADAPT MRT Trial)

Overseen By Pedja Klasnja, Ph.D. in Information Science

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Cognitive impairment, Palliative care, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health app, the HeartSteps mHealth Intervention, designed to help people with heart disease become more active and maintain that activity. Participants will use the app for three months, receiving activity suggestions and prompts to plan and reflect on their exercise. The goal is to determine how the app can best support increased physical activity. Individuals who have recently completed a cardiac rehab program and regularly use a smartphone might be a good fit. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance heart health management for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile health app to support physical activity, so it's likely you can continue your medications, but please confirm with the study team.

What prior data suggests that the HeartSteps mHealth intervention is safe for patients with heart disease?

Research has shown that mobile health apps like HeartSteps are generally safe for use. These apps manage health through technology and have not raised major safety concerns in studies. HeartSteps, specifically, offers activity suggestions and planning prompts to boost physical activity. No reports of serious problems have emerged from using such apps.

Since the study is in an early stage, it primarily examines how people naturally use the app. This indicates that more information is needed about its long-term safety. However, as a technology-based tool, it is less likely to cause physical harm compared to treatments like medications. Participants need only be comfortable using a smartphone or similar device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HeartSteps mHealth Intervention is unique because it leverages modern technology to encourage physical activity through personalized mobile app notifications and features. Unlike typical cardiovascular disease treatments that rely on medication or in-person therapy, this approach uses a combination of daily prompts, activity tracking with a Fitbit, and interactive tools to motivate and track progress. Researchers are excited about this trial because it could lead to a more engaging and accessible way for people to manage their heart health, potentially increasing adherence to physical activity recommendations and improving long-term outcomes.

What evidence suggests that the HeartSteps mHealth intervention is effective for increasing physical activity in heart disease patients?

Research has shown that mobile health tools like HeartSteps, provided to participants in this trial, can help people with heart disease become more active. Early results suggest that personalized activity tips and planning reminders effectively increase activity levels. One study found that patients using a similar app became more active in the first three months. Another study demonstrated that text messages and reminders encouraged people to maintain their activity. Overall, these tools aim to make it easier and more motivating for individuals with heart disease to stay active. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients who have heart disease and are either currently in phase II cardiac rehabilitation or have recently completed it. Participants will use the HeartSteps mobile health app to increase physical activity over a 3-month period.

Inclusion Criteria

I recently completed or will soon complete a heart rehab program at Michigan Medicine.

Owns and is a daily user of an Android or iPhone smartphone with study supported operating software

Understands English to enable informed consent, completion of study-related surveys, and compliance with study notifications

Exclusion Criteria

My cognitive function is mostly intact.

Wrist too large to wear an activity tracker comfortably. This will be assessed by asking participants if they have ever had difficulty wearing a watch in the past due to the band being too small

Ejection fraction <40%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the HeartSteps mHealth intervention for 3 months to support and increase physical activity, including wearing a Fitbit Charge activity tracker and receiving various notifications and prompts.

12 weeks

Naturalistic engagement with the intervention

Follow-up

Participants are monitored for changes in physical activity levels and affective associations with exercise after the intervention period.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HeartSteps mHealth Intervention

Trial Overview The study tests the HeartSteps mHealth intervention, which includes using a Fitbit Charge tracker and an app with features like activity suggestions, self-monitoring graphs, and weekly goals to promote long-term physical activity in heart disease patients.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants receive the HeartSteps mHealth intervention for 3 months to support and increase physical activity. Components include: 1. Activity Suggestions: Push notifications encouraging walks, randomized twice daily (probability 0.5). 2. Morning Salience Messages: Notifications highlighting positive aspects of activity, randomized daily (probability 0.5). 3. Planning Prompts: Notifications to plan next day's activity, randomized daily (probability 0.5). 4. Weekly Reflection: Prompts each Sunday to reflect on past activity, set goals, and plan for the next week. 5. Pull Interventions: In-app features like activity dashboards and planning tools. 6. Ecological Momentary Assessments (EMA): Daily and weekly surveys on psychosocial constructs related to physical activity. Participants wear a Fitbit Charge tracker to monitor activity, synced to their MyDataHelps account. The intervention aims to optimize engagement and physical activity levels.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Mobile applications for cardiovascular disease self-management have shown effectiveness in improving various health outcomes, such as reducing rehospitalization rates and enhancing quality of life among 607 patients across 10 studies.

Key features of successful apps included tracking healthy behaviors and personalized content, but the overall evidence quality was low, highlighting the need for larger, longer-term studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, acceptability and usefulness of mobile applications for cardiovascular disease self-management: Systematic review with meta-synthesis of quantitative and qualitative data. Coorey, GM., Neubeck, L., Mulley, J., et al.[2022]

Mobile health (mHealth) tools, such as interactive voice response and text messaging, have been shown to effectively improve lifestyle behaviors and management of cardiovascular diseases, particularly in low- and middle-income countries, based on a comprehensive review of studies since 2004.

These interventions can enhance preventive care by addressing key risk factors like weight, smoking, and physical activity, and have also demonstrated benefits in managing hypertension and improving medication adherence, suggesting they are a feasible option for improving health outcomes globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management. Piette, JD., List, J., Rana, GK., et al.[2023]

The MyHeartMate app, a game-based mobile intervention for coronary heart disease (CHD) patients, was well-accepted, with 94.8% of users engaging in tracking their health and activities, although it did not significantly improve overall physical activity levels compared to usual care.

The app did lead to a statistically significant reduction in triglyceride levels among users, indicating some efficacy in managing specific cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a game-based mobile app 'MyHeartMate' to promote lifestyle change in coronary disease patients: a randomized controlled trial. Gallagher, R., Chow, CK., Parker, H., et al.[2023]

Text messaging-based mHealth interventions have shown effectiveness in improving various behavioral risk factors for cardiovascular disease, such as smoking cessation, weight loss, and blood pressure management.

While these interventions demonstrate short-term benefits, further research is necessary to assess the long-term sustainability of these effects and their impact on overall clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Text Messaging in Cardiovascular Risk Factor Optimization. Klimis, H., Khan, ME., Kok, C., et al.[2018]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.010731?doi=10.1161/CIRCOUTCOMES.123.010731

Text Messages to Promote Physical Activity in Patients With ... Increases in physical activity have been linked to improved health outcomes in patients with cardiovascular disease. Despite these benefits, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03225521

A Micro-randomized Trial of HeartSteps, an mHealth ... The aim of this research is to evaluate the efficacy of contextually tailored activity suggestions and activity planning for increasing physical activity among ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10502072/

A randomized trial of a mobile health intervention to ... Amongst patients enrolled in center-based CR, a mHealth intervention did not improve 6-month outcomes but suggested differences at 3 months in ...

4. withpower.com withpower.com/trial/mobile-health-app-for-cardiovascular-disease-4bc3a

Mobile Health App for Cardiovascular Disease The HeartSteps mHealth Intervention is unique because it uses a mobile health app to help patients manage cardiovascular disease by promoting lifestyle changes ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10926792/

Acceptability of a Text Message‐Based Mobile Health ... We performed a qualitative substudy to assess the acceptability of a text message‐based mHealth intervention designed to increase and sustain physical activity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686283/

A mHealth Intervention to Preserve and Promote Ideal ... This is the first entirely technology-mediated multiple health behavior change intervention delivered to college students to promote cardiovascular health.

7. grantome.com grantome.com/grant/NIH/R01-HL125440-01

Heart Steps: Adaptive mHealth intervention for physical ... In this project, we will design and evaluate a personalized, adaptive mHealth intervention that leverages frequent interactions that people have with their ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.124.011005

Cardiovascular Disease Prevention With mHealth ... The nexus between physical activity and cardiovascular disease (CVD) risk reduction has revealed profound implications for lifestyle ...