Heart Failure
Conditions
Keywords
Medication Optimization
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.
Interventions
DEVICEENGAGE-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.
Sponsors
University of Michigan
Stanford University
Johns Hopkins University
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomization by site
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication optimization score at 90 days | From enrollment to the end of participation 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ-23) | Baseline and at 90 days | The secondary outcome will be heart failure symptoms as assessed by the difference between the intervention and the control groups in the 23-item Kansas City Cardiomyopathy Questionnaires (KCCQ-23) clinical summary score at 90 days. The KCCQ-23 quantifies patients' health status over the prior 2 weeks and has extensive data supporting its validity, reliability, and sensitivity to clinical change. Scores will be transformed into a 0-100 point rating, with lower scores representing worse health status. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Dorsch, PharmD
University of Michigan
Outcome results
None listed