Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure (NCT06750549) | Clinical Trial Compass
CompletedNot Applicable
Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure
United States134 participantsStarted 2025-02-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 decis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Medication optimization score at 90 days
Timeframe: From enrollment to the end of participation at 90 days