An interventional study of Mobile application intervention in Heart Failure, 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 2026-10-23.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
Physical activity is known to help patients with heart failure feel better and live longer though few patients with heart failure are sufficiently active. This study is evaluating whether a mobile health intervention can help patients with heart failure increase physical activity levels and remain active over time. The mobile health intervention consists of three parts: Notifications encouraging physical activity, a digital health coach trained in motivational interviewing, and a mobile application which encourages goal setting and activity monitoring.
Hypotheses:
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 50 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure 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.
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.
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.
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.
All participants will have a 1-week baseline period to establish participants pre-intervention step counts.
Behavioral: Mobile application intervention
Following a baseline period, participants will receive a 12 week mobile health intervention consisting of 3 main components: (1) a mobile application which supports goal-setting and self-monitoring; (2) an artificial intelligence (AI)-based health coach within the mobile application trained in principles of motivational interviewing and tailored to the needs of patients with heart failure (3) micro-randomized messages designed to enhance perceived competence around physical activity and promoting low level physical activity.
Step count 4 hours after a decision point for micro-randomized messages
Time frame: 4 hours after a decision point
Change in mean daily step count from baseline to 3 months
Participants will wear a Fitbit activity tracker for the duration of the study
Time frame: Baseline, 3 months
Percentage of transcripts with a recommendation that is deemed unsafe by the study team
AI-based health coaching conversations determined to be unsafe based on study team review.
Time frame: 3-month intervention
Changes in autonomous motivation from baseline to 3 months on the Behavioral Regulation in Exercise Questionnaire version 3 (BREQ-3)
The BREQ-3 is a widely used measure of the continuum of behavioral regulation in exercise psychology research. The BREQ-3 is 24 questions and the score ranges from 0-4 with higher scores indicating a greater level of endorsement of autonomous motivation. It will be measured at 2 time points. Autonomous motivation will be calculated by combining the identified, integrated, and intrinsic regulation subscales of the BREQ-3.
Time frame: Baseline, 3 months
Change in controlled motivation from baseline to 3 months on the Behavioral Regulation in Exercise Questionnaire version 3 (BREQ-3).
The BREQ-3 is a widely used measure of the continuum of behavioral regulation in exercise psychology research. The BREQ-3 is 24 questions and the score ranges from 0-4 with higher scores indicating a greater level of endorsement of controlled motivation. It will be measured at 2 time points. Autonomous motivation will be calculated by combining the identified, integrated, and intrinsic regulation subscales of the BREQ-3.
Time frame: Baseline, 3 months
Change in mean daily step count by week over the study duration
Time frame: Weekly up to 3 months (intervention period)
Plan to share: Yes — After study completion, the investigators will generate a de-identified dataset that will be published online and which will be shared with other researchers upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: After study completion.
Access criteria: De-identified dataset that will be published online and which will be shared with other researchers upon request.
No publications or documents are linked to this record.
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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