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NCT Number: NCT07750262

Mobile Health Intervention to Increase Activity in Heart Failure Study

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Heart Diseases Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location contact

Chelsie Gesierich, MPH

CONTACT

[email protected]

734-998-0514

Jessica Golbus, MD, MS

PRINCIPAL_INVESTIGATOR

About this study

Hypotheses:

  • Push notifications as part of a mobile health intervention will increase immediate (4 hour) physical activity levels among participants with heart failure.
  • A multicomponent mobile health intervention will increase physical activity levels at 3 months among participants with heart failure.
  • An artificial intelligence (AI) based health coach promoting physical activity will be safe among participants with heart failure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile Application Intervention

Behavioral

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 outcomes

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

    Time frame: 4 hours after a decision point

Secondary outcomes

  1. Change in mean daily step count from baseline to 3 months

    Time frame: Baseline, 3 months

    Participants will wear a Fitbit activity tracker for the duration of the study

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

    Time frame: 3-month intervention

    AI-based health coaching conversations determined to be unsafe based on study team review.

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

    Time frame: Baseline, 3 months

    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.

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

    Time frame: Baseline, 3 months

    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.

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

    Time frame: Weekly up to 3 months (intervention period)

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsie Gesierich, MPH

CONTACT

[email protected]

734-998-0514

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

MObile Health Intervention to INcrease Activity in Heart Failure Study: A Micro-Randomized Trial

Acronym: MOVIN-HF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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