Actively Recruiting
ADAPT Micro-Randomized Trial
Led by University of Michigan · Updated on 2025-09-04
60
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ADAPT Micro-Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be a patient within the Michigan Medicine clinical system with data available in the electronic health record after January 1, 2020
- Age over 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); or coronary artery disease or an acute coronary syndrome not requiring revascularization
You will not qualify if you...
- 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
- Currently receiving palliative care and/or in hospice care
- Severe valvular stenosis or regurgitation
- Unrevascularized left main coronary artery disease (> 50% obstruction) or proximal left anterior descending disease (>70% obstruction)
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
P
Pedja Klasnja, Ph.D. in Information Science
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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