RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-17
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06750549

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of heart failure
  2. * 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
  3. * Currently admitted with upcoming discharge or discharged from hospital within the prior 4 weeks
  4. * 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
  1. * Receives dialysis
  2. * Inotropic therapy after hospitalization
  3. * History of a prior solid organ transplant or actively listed on heart transplant waiting list
  4. * History of left ventricular assist device implantation
  5. * Cardiac amyloidosis
  6. * Currently pregnant or intends to become pregnant during the study period
  7. * Life expectancy estimated less than 6 months related to cardiac or non-cardiac comorbidities as per investigator's judgment
  8. * Actively enrolled in hospice or comfort care
  9. * Currently participating in an investigational device or drug study or having participated in such a study 30 days prior to screening
  10. * Subject without a compatible smartphone
  11. * Subject not proficient with written and spoken English
  12. * 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
  13. * Participant has diminished decision-making capacity
  14. * Admitted to or planned discharge to a skilled nursing facility or rehabilitation facility (acute or subacute)

Contacts and Locations

Study Contact

Brad Trumpower, MS
CONTACT
734-998-0294
trumpb@med.umich.edu

Principal Investigator

Michael Dorsch, PharmD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

Stanford Cardiovascular Clinic
Stanford, California, 94305
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
U-M Frankel Cardiovascular Center
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Michael Dorsch, PharmD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-17
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-02-17
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Medication Optimization

Additional Relevant MeSH Terms

  • Heart Failure