NCT07750262

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
15mo left

Started Aug 2026

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Nov 2027

First Submitted

Initial submission to the registry

July 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

July 25, 2026

Last Update Submit

August 1, 2026

Conditions

Keywords

Physical activityDigital healthMobile HealthArtificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • Step count 4 hours after a decision point for micro-randomized messages

    4 hours after a decision point

Secondary Outcomes (5)

  • Change in mean daily step count from baseline to 3 months

    Baseline, 3 months

  • Percentage of transcripts with a recommendation that is deemed unsafe by the study team

    3-month intervention

  • Changes in autonomous motivation from baseline to 3 months on the Behavioral Regulation in Exercise Questionnaire version 3 (BREQ-3)

    Baseline, 3 months

  • Change in controlled motivation from baseline to 3 months on the Behavioral Regulation in Exercise Questionnaire version 3 (BREQ-3).

    Baseline, 3 months

  • Change in mean daily step count by week over the study duration

    Weekly up to 3 months (intervention period)

Study Arms (1)

Mobile application intervention

EXPERIMENTAL

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

Behavioral: Mobile application intervention

Interventions

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.

Mobile application intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Heart FailureMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Jessica Golbus, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelsie Gesierich, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Cardiology

Study Record Dates

First Submitted

July 25, 2026

First Posted

August 6, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

August 6, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.

Locations