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Active Not RecruitingNCT06750549

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

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
130 (estimated)
Sponsor
University of Michigan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEENGAGE-HF Mobile ApplicationThe 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.

Timeline

Start date
2025-02-18
Primary completion
2026-05-31
Completion
2026-05-31
First posted
2024-12-27
Last updated
2026-02-18

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06750549. Inclusion in this directory is not an endorsement.