ADAPT Micro-Randomized Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weekly number of minutes of moderate to vigorous physical activity

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.

Time frame
Baseline, 12 weeks

Secondary outcomes

1

3-hour step count

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.

Time frame
12 weeks
2

Daily step count

Number of steps per day, assessed by the Fitbit Charge 6 activity tracker.

Time frame
12 weeks
3

Affective exercise experiences (AFFEXX) scale

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.

Time frame
Baseline, 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator