Clinical trial NCT06750549: Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure
Official title: Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure: The ENGAGE-HF Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Medication Optimization
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Johns Hopkins University
name: Boston University
First posted: 2024-12-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization by site
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Medication optimization score at 90 days
timeFrame: From enrollment to the end of participation at 90 days
Secondary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ-23)
timeFrame: Baseline and at 90 days
Other outcomes:
measure: Kansas City Medical Optimization (KCMO) score
timeFrame: From enrollment to the end of participation at 90 days
measure: Modified Continuous 4-Pillar Score
timeFrame: From enrollment to the end of participation at 90 days
measure: 90 day all-cause mortality
timeFrame: From enrollment to the end of participation at 90 days
measure: Heart failure hospitalization
timeFrame: From enrollment to the end of participation at 90 days
measure: Emergency department visits for heart failure
timeFrame: From enrollment to the end of participation at 90 days
measure: Outpatient intravenous diuresis
timeFrame: From enrollment to the end of participation at 90 days
measure: Process measures
timeFrame: From enrollment to the end of participation at 90 days
measure: Mini-Cog Cognitive Assessment
timeFrame: At baseline
measure: Memory Recall - Immediate
timeFrame: Baseline and at 90 days
measure: Choice Reaction Time
timeFrame: Baseline and at 90 days
measure: Visual Paired Associates
timeFrame: Baseline and at 90 days
measure: Digit Symbol Matching
timeFrame: Baseline and at 90 days
measure: Spatial Memory
timeFrame: Baseline and at 90 days
measure: Memory Recall - Delayed
timeFrame: Baseline and at 90 days
Locations:
city: Stanford
country: United States
facility: Stanford Cardiovascular Clinic
state: California
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: U-M Frankel Cardiovascular Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michael Dorsch, PharmD
role: PRINCIPAL_INVESTIGATOR
References: