ADAPT Micro-Randomized Trial

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT06915220
• Lead Sponsor: University of Michigan

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Weekly number of minutes of moderate to vigorous physical activity	Baseline, 12 weeks	The primary outcome of the study is number of weekly minutes of moderate to vigorous physical activity (MVPA), as assessed by the Fitbit Charge 6 activity tracker.; Primary analysis will assess the difference in MVPA between the baseline week and the last (i.e. 12th) week of the study.

Secondary Outcome Measures

Name	Time	Method
Daily step count	12 weeks	Number of steps per day, assessed by the Fitbit Charge 6 activity tracker.
3-hour step count	12 weeks	Number of steps, as assessed by the Fitbit Charge 6 activity tracker, measured in the three-hour window following the randomization of activity suggestions.; This outcome will be assessed after each decision point for the micro-randomized activity suggestions. Each participant will have two decision points per day for the duration of the study.
Affective exercise experiences (AFFEXX) scale	Baseline, 12 weeks	A validated 36-item self-report instrument that assesses participants' affective associations with physical activity.; AFFEXX scale will be administered weekly for the duration of the study. The main analysis of this outcome will assess pre-post differences in the AFFEXX score between baseline and 12th week.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States