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NCT Number: NCT06915220

ADAPT Micro-Randomized 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.

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Key information

Conditions

Cardiovascular Diseases Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Brahmajee Nallamothu, M.D.

SUB_INVESTIGATOR

Jessica Golbus, M.D.

SUB_INVESTIGATOR

Mark Newman, Ph.D.

SUB_INVESTIGATOR

Pedja Klasnja, Ph.D.

CONTACT

[email protected]

734-763-3581

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Weekly number of minutes of moderate to vigorous physical activity

    Time frame: 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 outcomes

  1. 3-hour step count

    Time frame: 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.

  2. Daily step count

    Time frame: 12 weeks

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

  3. Affective exercise experiences (AFFEXX) scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pedja Klasnja, Ph.D. in Information Science

CONTACT

[email protected]

734-763-3581

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: ADAPT MRT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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