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ADAPT Micro-Randomized Trial

Study acronym: ADAPT MRT
StatusRecruiting
PhaseNot applicable
Started2025-05-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Sep 2026 → Feb 2027
See other at-risk trials from University of Michigan

Amendment history

2026-09-26
notable
Enrollment increased: 60 → 70 participants
Primary completion pushed: 2026-09 → 2027-02
Completion pushed: 2026-10 → 2027-02
2026-05-27
minor
Study Status v2
Primary completion date2026-03→2026-09
Completion date2026-03→2026-10
2025-08-27
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-10→2026-03
Completion date2025-10→2026-03
Start dateestimated 2025-04→confirmed 2025-05-20
Study sitesdetails revised at 1 of 1 site
2025-04-01
minor
Original filing
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.
Trial Details
NCT Number NCT06915220
Lead Sponsor University of Michigan
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Cardiovascular Diseases
Enrollment 70 participants
Start Date 2025-05-20
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-25