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

NCT07805811 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-09-04

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Martha Abshire Saylor, PhD, RN · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-04
Primary Completion
2030-11-30
Completion
2031-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07805811 on ClinicalTrials.gov