ADAPT: HeartSteps program to increase activity after cardiac rehabilitation
ADAPT Micro-Randomized Trial
This 3-month test sees if the HeartSteps smartphone program plus a Fitbit can help people who are completing or recently finished phase II cardiac rehabilitation increase and keep up their physical activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06915220 on ClinicalTrials.gov |
What this trial studies
The ADAPT micro-randomized pilot will enroll 60 patients who are completing or recently completed phase II cardiac rehabilitation at Michigan Medicine for three months. Participants will use the HeartSteps mobile intervention on their smartphone and wear a Fitbit Charge during waking hours while the study delivers different activity-support components in a micro-randomized schedule. The trial collects quantitative step and activity data along with qualitative participant feedback to optimize timing, messaging, and affective strategies aimed at improving positive associations with physical activity. Results will be used to refine HeartSteps for longer-term support of physical activity in cardiac patients.
Who should consider this trial
Good fit: Adults over 18 who are patients in the Michigan Medicine system, are completing or completed phase II cardiac rehabilitation within the past 30 days, and who use a compatible smartphone and understand English are ideal candidates.
Not a fit: Patients with orthopedic or neurological conditions that prevent safe physical activity, those unable to use a smartphone or wearable device, or those not treated within the Michigan Medicine system may not receive benefit.
Why it matters
Potential benefit: If successful, the program could help cardiac rehab patients increase daily physical activity and maintain exercise habits long-term using a scalable smartphone-and-wearable approach.
How similar studies have performed: Mobile health and wearable-based interventions have shown promise for increasing activity in cardiac and general populations, though micro-randomized optimization of HeartSteps specifically in post–cardiac rehab patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be a patient within the Michigan Medicine clinical system with data available in the electronic health record after January 1, 2020. * Age \> 18 * 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. * Will be completing within 30 days or have completed in the last 30 days the cardiac rehabilitation program at Michigan Medicine based on one of the following indications: * Coronary artery disease (including acute coronary syndromes and stable angina) following percutaneous coronary intervention (PCI) * Coronary artery disease following coronary artery bypass surgery (CABG)\] * Valve repair or replacement (either surgical or percutaneous) * Coronary artery disease or an acute coronary syndrome not requiring revascularization Exclusion Criteria: * Orthopedic or neurological condition limiting ability to actively engage in moderate intensity physical activity (e.g., brisk walking) * Greater than mild cognitive impairment * 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." * Currently receiving palliative care and/or in hospice care * Severe valvular stenosis or regurgitation * Unrevascularized left main coronary artery disease (\> 50% obstruction on angiography) or proximal left anterior descending disease (\>70% obstruction on angiography). * Exercise-induced ventricular tachycardia * Cardiac arrest within the prior 6 months * New York Heart Association (NYHA) class III or IV heart failure * Pulmonary arterial hypertension treated with inhaled or intravenous pulmonary hypertension-specific therapy * Ejection fraction \<40% * Determined to be unsafe for participation in this program as assessed by a clinical nurse or investigative team.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Pedja Klasnja, Ph.D. in Information Science
- Email: klasnja@umich.edu
- Phone: 734-763-3581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.