ADAPT Micro-Randomized Trial

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06915220
Status
Recruiting
Apply to this trial

Conditions

  • Cardiovascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mobile health app — BEHAVIORAL
    HeartSteps is an innovative mobile health (mHealth) app designed for cardiac rehabilitation patients. The app features dynamic push notifications, daily and weekly surveys to capture psychosocial data, and an in-app dashboard that provides feedback on activity levels, goal progress, and reminders. Integrated with a Fitbit Charge tracker, HeartSteps emphasizes behavioral changes through engaging features. The intervention is personalized to meet individual needs and preferences, enhancing patient engagement and promoting sustained physical activity.

Study Details

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.

Key Dates

Start date
May 20, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention
    Participants receive the HeartSteps mHealth intervention for 3 months to support and increase physical activity. Components include: 1. Activity Suggestions: Push notifications encouraging walks, randomized twice daily (probability 0.5). 2. Morning Salience Messages: Notifications highlighting positive aspects of activity, randomized daily (probability 0.5). 3. Planning Prompts: Notifications to plan next day's activity, randomized daily (probability 0.5). 4. Weekly Reflection: Prompts each Sunday to reflect on past activity, set goals, and plan for the next week. 5. Pull Interventions: In-app features like activity dashboards and planning tools. 6. Ecological Momentary Assessments (EMA): Daily and weekly surveys on psychosocial constructs related to physical activity. Participants wear a Fitbit Charge tracker to monitor activity, synced to their MyDataHelps account. The intervention aims to optimize engagement and physical activity levels.

Primary Outcome Measure

Weekly number of minutes of moderate to vigorous physical activity [ Time Frame: Baseline, 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Pedja Klasnja, Ph.D.
[email protected]
734-763-3581
Jessica Golbus, M.D. (SUB_INVESTIGATOR)
Brahmajee Nallamothu, M.D. (SUB_INVESTIGATOR)
Mark Newman, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By research site
University of Michigan· Ann Arbor, MI

Related Studies