Recruiting

Mobile Health Intervention

Sponsor:

University of Michigan

Code:

NCT07750262

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mobile application intervention

Study Details

Brief summary:

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.

Conditions

Heart Failure

Study ID

NCT07750262

Start date

Aug 12, 2026

Status verified date

Oct, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Michigan Medicine patient with a diagnosis of heart failure (HF)
  • Age 18 years and older at screening and able to provide consent
  • New York Heart Association class 2 or 3 HF symptoms
  • Safe for home physical activity as determined by treating clinician
  • Own a smartphone with a compatible Apple or Android operating system
  • Fluent in spoken and written English

Exclusion Criteria:

  • Hospitalized for HF within the prior 6 weeks
  • Orthopedic or neurological condition significantly limiting physical activity
  • Greater than mild cognitive impairment
  • Enrolled in hospice care
  • Severe valvular stenosis
  • Exercise-induced ventricular tachycardia
  • Obstructive left main or proximal left anterior descending coronary artery disease
  • Pulmonary hypertension treated with inhaled or intravenous therapy
  • Currently pregnant or planning to become pregnant
  • Determined to be unsafe for participation as assessed by the investigative team.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mobile application intervention

All participants will have a 1-week baseline period to establish participants pre-intervention step counts.

Interventions

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.

Primary outcome measure

  • Step count 4 hours after a decision point for micro-randomized messages [ Time Frame: 4 hours after a decision point ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Jessica Golbus, MD, MS

More Information

Sponsor

University of Michigan

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • Physical activity
  • Digital health
  • Mobile Health
  • Artificial Intelligence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.