Clinical trial NCT06915220: ADAPT Micro-Randomized Trial
Official title: ADAPT Micro-Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiac Rehabilitation
Physical activity
mobile health intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study uses a micro-randomized trial (MRT) design to optimize the HeartSteps mHealth intervention for physical activity. The following components are macro-randomized:

1. Activity Suggestions: Randomized twice daily (probability 0.5), averaging one suggestion per day.
2. Morning Salience Messages: Randomized daily (probability 0.5), averaging one message every other day.
3. Planning Prompts: Randomized daily (probability 0.5), averaging one prompt every other day.

The following components are provided without randomization:

4, Weekly Reflection: Prompts participants 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.

This plan collects data to optimize intervention timing and content for better engagement and physical activity outcomes.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weekly number of minutes of moderate to vigorous physical activity
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: 3-hour step count
timeFrame: 12 weeks
measure: Daily step count
timeFrame: 12 weeks
measure: Affective exercise experiences (AFFEXX) scale
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: