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NOT YET RECRUITING
NCT07805811
PHASE2

Testing Heart Failure Resilience Intervention for Caregivers (HEROIC) in Advanced Heart Failure

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

This study will test the mechanisms of a multi-component, nurse-led, primary palliative care intervention, HEart failure Resilience Intervention for Caregivers (HEROIC) to improve caregiver mental well-being, patient health-related quality of life and unplanned acute care in the setting of advanced heart failure. The investigators will conduct a multi-site, randomized controlled trial to test proposed mechanisms of action in a large sample (N=500) of persons with heart failure and the caregivers. The investigators will also examine variation in response to HEROIC components by heart failure subgroup (ventricular assist device, heart transplant or medically managed heart failure).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2027-01-04

Completion Date

2031-03-31

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

BEHAVIORAL

HEROIC program

The HEart Failure Resilience Intervention for Caregivers (HEROIC) is a theory- and evidence-based primary palliative care intervention including 5 individualized nurse-led sessions conducted over 10 weeks via video calls. HEROIC helps caregivers identify and address caregiving and palliative care needs for the patient, while also focusing on caregiver mental health, leveraging multi-level resilience resources: individual (goal-setting, self-care), community (social support, palliative/clinical, community) and existential (life purpose).

BEHAVIORAL

Active Comparator Control 1

The control group will receive: 1. Written materials with resources from organizations such as the National Alliance on Caregiving, the Heart Failure Society of America and International Society for Heart \& Lung Transplantation (ISHLT) (patient and family education); 2. Home safety tips for caregivers developed by the National Institute on Aging; and 3. A monthly newsletter highlighting a heart healthy recipe, a self-care behavior such as getting adequate sleep, and one clinical or community resource; and 4. Bi-weekly check-in calls to discuss heart failure disease education and home safety tips.

Locations (2)

University of Colorado Anschutz

Denver, Colorado, United States

Johns Hopkins University, School of Nursing

Baltimore, Maryland, United States