Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure: The ENGAGE-HF Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of heart failure

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

• Currently admitted with upcoming discharge or discharged from hospital within the prior 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

Locations
United States
California
Stanford Cardiovascular Clinic
RECRUITING
Stanford
Maryland
The Johns Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
Michigan
U-M Frankel Cardiovascular Center
RECRUITING
Ann Arbor
Contact Information
Primary
Brad Trumpower, MS
trumpb@med.umich.edu
734-998-0294
Time Frame
Start Date: 2025-02-18
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 130
Treatments
Experimental: Intervention
The ENGAGE-HF intervention is a combination of a patient-facing mobile application that is integrated with a remote blood pressure cuff and scale along with a clinician-facing dashboard. The mobile application helps complete standard ambulatory monitoring recommended by heart failure clinicians. Simultaneously, the application includes visualizations of that data and education for patients that is intended to promote patient engagement and patient understanding of heart failure care. The information is then made available to treating clinicians via a PDF summary to facilitate outpatient management of the patient by the clinician. There are also a select set of notifications triggered by the ENGAGE-HF platform that will be transmitted to the treating clinician.
No_intervention: Control Group
Participants randomized to the control group will receive usual heart failure care.
Related Therapeutic Areas
Sponsors
Collaborators: Stanford University, Boston University, Johns Hopkins University
Leads: University of Michigan

This content was sourced from clinicaltrials.gov