Mobile app for managing heart failure
Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure: The ENGAGE-HF Study
This study is testing a mobile app that helps people with heart failure keep track of their health and medications to see if it can improve their treatment and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 3 sites (Stanford, California and 2 other locations) |
| Trial ID | NCT06750549 on ClinicalTrials.gov |
What this trial studies
The ENGAGE-HF mobile application is designed to help patients with heart failure track their health status, vital signs, and medication therapy quality over time. By utilizing behavior change strategies such as self-monitoring and clinician feedback through a dashboard, the study aims to improve the optimization of heart failure treatments and enhance patients' quality of life. Additionally, an optional sub-study will assess cognitive function among participants. This innovative approach seeks to empower patients in managing their condition more effectively.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with heart failure who have a left ventricular ejection fraction of less than 50% and are either currently hospitalized or recently discharged.
Not a fit: Patients receiving dialysis, those on inotropic therapy, or with a life expectancy of less than 6 months are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to better management of heart failure and improved quality of life for patients.
How similar studies have performed: Other studies utilizing mobile health applications for chronic disease management have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Stanford, California and 2 other locations
- Stanford Cardiovascular Clinic — Stanford, California, United States (Recruiting)
- The Johns Hopkins Hospital — Baltimore, Maryland, United States (Not_yet_recruiting)
- U-M Frankel Cardiovascular Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Michael Dorsch, PharmD — University of Michigan
- Study coordinator: Brad Trumpower, MS
- Email: trumpb@med.umich.edu
- Phone: 734-998-0294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.