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

NCT06750549 | Completed DMC

• 1 other identifier: HUM00240067
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 3

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

Keywords

Medication Optimization

Outcome Measures

Primary Outcomes (1)

• Medication optimization score at 90 days

  The primary outcome will be the difference in the medication optimization score at 90 days between the intervention and control group. The MOS is a percent between 0 (least optimized) and 100 (most optimized), which represents the extent of medication optimization that needs to be performed. Inputs for the score include medications, vital signs, and laboratory values, and thus, the score accounts for contraindications to medical therapy titration. The score has been shown to correlate with clinical outcomes in two large randomized controlled trials.

  From enrollment to the end of participation at 90 days

Secondary Outcomes (1)

• Kansas City Cardiomyopathy Questionnaire (KCCQ-23)

  Baseline and at 90 days

Other Outcomes (14)

• Kansas City Medical Optimization (KCMO) score

  From enrollment to the end of participation at 90 days

• Modified Continuous 4-Pillar Score

  From enrollment to the end of participation at 90 days

• 90 day all-cause mortality

  From enrollment to the end of participation at 90 days

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Device: ENGAGE-HF Mobile Application

Control Group

NO INTERVENTION

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

Interventions

ENGAGE-HF Mobile Application 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• Johns Hopkins University: collaborator
• Boston University: collaborator
• Stanford University: collaborator

Study Sites (3)

Stanford Cardiovascular Clinic

Stanford, California, 94305, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

U-M Frankel Cardiovascular Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael Dorsch, PharmD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pharmacy

Model Details: 1:1 randomization by site

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 27, 2024
• Study Start: February 18, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (3)