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

Trial Summary

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 data supports the effectiveness of the HeartSteps mHealth Intervention treatment for cardiovascular disease?

Research shows that mobile health apps can help people with cardiovascular disease by improving physical activity, medication adherence, and reducing risk factors like high blood pressure and cholesterol. These apps often include features like tracking healthy behaviors and providing personalized content, which users find helpful. ^{1 2 3 4 5}

Is the Mobile Health App for Cardiovascular Disease safe for humans?

The research on mobile health apps for cardiovascular disease, including those like HeartSteps, suggests they are generally safe for humans. These apps have been shown to help improve health behaviors and manage risk factors without reported safety concerns, but more extensive studies are needed to confirm their long-term safety. ^{2 3 6 7 8}

How is the HeartSteps mHealth Intervention treatment different from other treatments 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 such as increased physical activity and better medication adherence. Unlike traditional treatments, this app offers personalized, customizable content and self-monitoring features, making it a scalable and accessible option for improving cardiovascular health. ^{1 3 4 5 9}

What is the purpose of this trial?

The goal of this study is to collect quantitative and qualitative data that can be used to optimize the HeartSteps mHealth intervention for physical activity. The current version of the intervention is intended to help patients with heart disease increase and maintain their physical activity long-term. To accomplish this goal, a 3-month pilot micro-randomized trial (MRT) will be conducted with 60 patients who are currently completing or have recently completed phase II cardiac rehabilitation (CR). The core of the study participation is the use of the HeartSteps intervention over the course of 3 months. This includes wearing the Fitbit Charge activity tracker during waking hours and using the HeartSteps intervention to support their efforts to be active. The HeartSteps intervention consists of two sets of intervention components: (1) components intended to improve participants' affective associations with physical activity, including activity suggestions designed to to trigger positive feelings and associate them with being active, and prompts to bring their awareness to intrinsically motivating aspects of being active; and (2) components that target reflective self-regulatory processes, including graphs for self-monitoring, prompts to plan activity, and weekly activity goals. How exactly, and how much, participants will use HeartSteps will not be prescribed since our goal is to understand naturalistic trajectory of engagement with the intervention.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The mobile revolution--using smartphone apps to prevent cardiovascular disease. [2022]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Role of Text Messaging in Cardiovascular Risk Factor Optimization. [2018]

5. England 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Using mobile technology to support lower-salt food choices for people with cardiovascular disease: protocol for the SaltSwitch randomized controlled trial. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

Increasing Engagement in the Electronic Framingham Heart Study: Factorial Randomized Controlled Trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Digital health interventions for the prevention of cardiovascular disease: a systematic review and meta-analysis. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Mobile Health Initiatives to Improve Outcomes in Primary Prevention of Cardiovascular Disease. [2020]