An interventional study of mobile health app in Cardiovascular Diseases, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Michigan · Not applicable, Interventional, and Supportive care
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: mobile health app
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.
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
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
Daily step count
Number of steps per day, assessed by the Fitbit Charge 6 activity tracker.
Time frame: 12 weeks
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Feb 2027, 21 months after the start.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 21 months is below that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Sep 2026 → Feb 2027 and completion Oct 2026 → Feb 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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