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Not yet taking people in United StatesPhase 2

Testing a Nurse-Led Support Program for Caregivers of People With Advanced Heart Failure

Tests a nurse-led support program for caregivers of people with advanced heart failure.

Plain-language title generated from the registry record
Registry title: Testing Heart Failure Resilience Intervention for Caregivers (HEROIC) in Advanced Heart Failure

Key facts

Where
Baltimore and Denver, United StatesSee the 2 sites
Phase
Phase 2

Where in United States

  • Johns Hopkins University School of NursingBaltimore, United StatesNo longer taking part
  • University of Colorado AnschutzDenver, United StatesNo longer taking part

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Trial details

Who runs it
Johns Hopkins University
Trial code
NCT07805811
Record updated
4 September 2026
Original description
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).Read full original descriptionShow less

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

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).

Exclusion: Patients and caregivers who screen positive for severe cognitive impairment Telephone Interview for Cognitive Screening (TICS-M) will be excluded.

Caregiver Inclusion Criteria:; English or Spanish-speaking; > 18 years old; Supports at least one activity of daily living (ADL) or instrumental activity of daily living IADL) for the person with HF (care recipient); Lives with the person with HF or visits regularly (e.g. weekly phone calls and visits at least once per month) to provide ADL/IADL support; ≥5 on the Zarit Burden Interview; Patient Inclusion Criteria:; English or Spanish-speaking; > 18 years old; Reports needing help with at least one activity of daily living or instrumental activity of daily living; Identifies a primary caregiver AND caregiver consents; Diagnosed with heart failure. AND; If Medically managed, no Ventricular Assist Device (VAD) or Transplant (TX): Documentation of HF with preserved ejection fraction OR HF with reduced ejection fraction (LVEF<40%) OR Documented American College of Cardiology / American Heart Association (ACC/AHA) HF stage C or D (EMR) OR Documentation of New York Heart Association functional class II - IV (EMR); If ventricular assist device: > 1 month since implant AND ambulatory/outpatient; If heart transplant: > 1 month since Heart Transplant (HTx) AND ambulatory/outpatient.

ClinicalTrials.gov NCT07805811