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

NCT ID: NCT06750549

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ENGAGE-HF Mobile Application

Intervention Type: DEVICE

The mobile app aids ambulatory heart failure monitoring and patient engagement through several features:

Physiologic Monitoring: Daily tracking of blood pressure, weight, and heart rate using Bluetooth devices. Data is shown in graphical and tabular formats.

Health Status Assessment: Biweekly KCCQ-12 surveys and dizziness questions provide scores (0-100), helping visualize therapy benefits and medication adherence, and reducing clinician inertia.

Medication Checklist: Lists current medications and target doses for common heart failure therapies, encouraging adherence and optimization, with alerts for potential improvements.

Education: Animated videos from heart failure experts and societies explain medications, monitoring rationale, app features, and interpretation of data.

The app enhances heart failure management via consistent monitoring, assessment, medication adherence, and educational content.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ENGAGE-HF Mobile Application

The mobile app aids ambulatory heart failure monitoring and patient engagement through several features:

Physiologic Monitoring: Daily tracking of blood pressure, weight, and heart rate using Bluetooth devices. Data is shown in graphical and tabular formats.

Health Status Assessment: Biweekly KCCQ-12 surveys and dizziness questions provide scores (0-100), helping visualize therapy benefits and medication adherence, and reducing clinician inertia.

Medication Checklist: Lists current medications and target doses for common heart failure therapies, encouraging adherence and optimization, with alerts for potential improvements.

Education: Animated videos from heart failure experts and societies explain medications, monitoring rationale, app features, and interpretation of data.

The app enhances heart failure management via consistent monitoring, assessment, medication adherence, and educational content.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Michael Dorsch

Associate Professor of Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Dorsch, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Stanford Cardiovascular Clinic

Stanford, California, United States

Site Status: RECRUITING

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: NOT_YET_RECRUITING

U-M Frankel Cardiovascular Center

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brad Trumpower, MS

Role: CONTACT

trumpb@med.umich.edu

734-998-0294

Facility Contacts

Kylie Oakes

Role: primary

engage-hf-trial@stanford.edu

650-736-9831

Henry Zhao

Role: primary

hzhao34@jhu.edu

443-605-8435

Seth Martin, MD, MHS

Role: backup

410-502-0469

Brad Trumpower, MS

Role: primary

ENGAGE-HF@med.umich.edu

734-995-0294

Other Identifiers

HUM00240067

Identifier Type: -

Identifier Source: org_study_id