Status:
RECRUITING
ADAPT Micro-Randomized Trial
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06915220
Start Date
May 20 2025
End Date
March 1 2026
Last Update
September 4 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109