Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure

Last updated: February 25, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

ENGAGE-HF Mobile Application

Clinical Study ID

NCT06750549
HUM00240067
  • Ages > 18
  • All Genders

Study Summary

The ENGAGE-HF mobile application tracks three key features over time: (1) heart failure health status, (2) vital signs (e.g., blood pressure, heart rate) and weight, and (3) the quality of heart failure medication therapy. Helping patients understand how these characteristics interact and change over time may improve their ability to understand and manage heart failure.

In this study, the investigators aim to evaluate whether the ENGAGE-HF mobile application, by facilitating the behavior change strategies of self-monitoring and feedback, and a clinician-facing dashboard, improves the optimization of heart failure guideline-directed medical therapies (GDMT) and quality of life.

An optional sub-study of cognitive function will invite all eligible participants enrolled in the main study to participate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of heart failure

  • Last left ventricular ejection fraction within 2 years < 50% based onechocardiogram, MRI, CT, or nuclear perfusion and, if no ejection fractiondocumented, then clinical documentation of heart failure with reduced ejectionfraction

  • Currently admitted with upcoming discharge or discharged from hospital within theprior 4 weeks

  • At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA,or SGLT2i) not yet initiated or at < 50% of target dose at time of enrollment

Exclusion

Exclusion Criteria:

  • Receives dialysis

  • Inotropic therapy after hospitalization

  • History of a prior solid organ transplant or actively listed on heart transplantwaiting list

  • History of left ventricular assist device implantation

  • Cardiac amyloidosis

  • Currently pregnant or intends to become pregnant during the study period

  • Life expectancy estimated less than 6 months related to cardiac or non-cardiaccomorbidities as per investigator's judgment

  • Actively enrolled in hospice or comfort care

  • Currently participating in an investigational device or drug study or havingparticipated in such a study 30 days prior to screening

  • Subject without a compatible smartphone

  • Subject not proficient with written and spoken English

  • Any other disorder or condition that, in the opinion of the investigator would posea risk to subject safety or interfere with the study evaluation, procedures orcompletion

  • Participant has diminished decision-making capacity

  • Admitted to or planned discharge to a skilled nursing facility or rehabilitationfacility (acute or subacute)

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: ENGAGE-HF Mobile Application
Phase:
Study Start date:
February 18, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Stanford Cardiovascular Clinic

    Stanford, California 94305
    United States

    Active - Recruiting

  • The Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • U-M Frankel Cardiovascular Center

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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