Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure (ENGAGE-HF)

University of Michigan

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: ENGAGE-HF Mobile Application

Study type: Interventional

Funder types: Other

Identifiers

NCT06750549

HUM00240067

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Receives dialysis
• Inotropic therapy after hospitalization
• History of a prior solid organ transplant or actively listed on heart transplant waiting 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-cardiac comorbidities as per investigator's judgment
• Actively enrolled in hospice or comfort care
• Currently participating in an investigational device or drug study or having participated 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 pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Participant has diminished decision-making capacity
• Admitted to or planned discharge to a skilled nursing facility or rehabilitation facility (acute or subacute)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Device: ENGAGE-HF Mobile Application

Control Group

No Intervention group

Description:

Participants randomized to the control group will receive usual heart failure care.