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

Conditions

• Caregiver
• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HEROIC program — BEHAVIORAL
  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).
• Active Comparator Control 1 — BEHAVIORAL
  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.

Study Details

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 Dates

First listed

Sep 4, 2026

Start date

Jan 4, 2027

Status verified

Sep 2026

Primary completion

Nov 30, 2030

Completion

Mar 31, 2031

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: 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).
• Active Comparator: Control condition
  The control group will receive written educational materials related to Heart Failure (HF) management, home safety tips, and supportive resources. This control is selected to provide a comparative baseline that reflects typical care practices without the active intervention elements .

Primary Outcome Measure

Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36) [ Time Frame: 12 weeks ]

Central Contacts

• Martha Abshire Saylor, Principal Investigator, PhD, RN
  HEROIC phone number
  [email protected]
• Meagan Clemence, Study Coordinator, M.Ed

Locations (2)

Find similar trials in Denver, CO

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