NCT07805811

Brief 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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_2 heart-failure

Timeline
52mo left

Started Jan 2027

Longer than P75 for phase_2 heart-failure

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

January 4, 2027

Expected
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2030

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2031

Last Updated

September 4, 2026

Status Verified

September 1, 2026

Enrollment Period

3.9 years

First QC Date

September 1, 2026

Last Update Submit

September 1, 2026

Conditions

Heart FailureCaregiver

Keywords

heart failurecaregivingsupport programpalliative careheart transplantventricular assist device

Outcome Measures

Primary Outcomes (3)

  • Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36)

    Short Form Health Survey (SF-36), mental health composite score. The mental health composite score is an average of 4 out of 8 sub-scales. Scoring is 0 to 100, where higher scores indicate better mental health and fewer psychological distress symptoms.

    12 weeks

  • Health-related quality of Life (patient) as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Kansas City Cardiomyopathy Questionnaire (KCCQ), 12 item version. Scoring is from 0 to 100 where higher scores indicate better health-related quality of life.

    12 weeks

  • Number of unplanned acute care (patient) visits

    number of unplanned hospitalization, emergency room visit, urgent care and unscheduled/same-day visits

    1 year

Secondary Outcomes (4)

  • Caregiver burden as assessed by Zarit Burden Interview

    12 weeks

  • Self-efficacy (caregiver) assessed by Coping Self-Efficacy Scale (CSE)

    12 weeks

  • Self-care (patient) as assessed by the Heart Failure Self-Care Index

    12 weeks

  • Palliative Care Needs as assessed by the Integrated Palliative Outcomes Scale (iPOS)

    12 weeks

Study Arms (2)

HEROIC program

EXPERIMENTAL

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: HEROIC program

Control condition

ACTIVE COMPARATOR

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 .

Behavioral: Active Comparator Control 1

Interventions

Active Comparator Control 1BEHAVIORAL

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.

Control condition
HEROIC programBEHAVIORAL

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).

Also known as: Caregiver Support
HEROIC program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Anschutz

Denver, Colorado, 80217, United States

Location

Johns Hopkins University, School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

  • Abshire Saylor M, Clair CA, Curriero S, DeGroot L, Nelson K, Pavlovic N, Taylor J, Gallo JJ, Szanton S. Analysis of action planning, achievement and life purpose statements in an intervention to support caregivers of persons with heart failure. Heart Lung. 2023 Sep-Oct;61:8-15. doi: 10.1016/j.hrtlng.2023.04.002. Epub 2023 Apr 12.

    PMID: 37059045BACKGROUND

  • Abshire Saylor M, Pavlovic N, DeGroot L, Peeler A, Nelson KE, Perrin N, Gilotra NA, Wolff JL, Davidson PM, Szanton SL. Feasibility of a Multi-Component Strengths-Building Intervention for Caregivers of Persons With Heart Failure. J Appl Gerontol. 2023 Dec;42(12):2371-2382. doi: 10.1177/07334648231191595. Epub 2023 Sep 14.

    PMID: 37707361BACKGROUND

  • Abshire Saylor M, Pavlovic NV, DeGroot L, Jajodia A, Hladek MD, Perrin N, Wolff J, Davidson PM, Szanton S. Strengths-building through life purpose, self-care goal setting and social support: Study protocol for Caregiver Support. Contemp Clin Trials Commun. 2022 May 5;28:100917. doi: 10.1016/j.conctc.2022.100917. eCollection 2022 Aug.

    PMID: 35602009BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Martha Abshire Saylor, PhD, RN

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha Abshire Saylor, Principal Investigator, PhD, RN

CONTACT

HEROIC phone numbermabshir1@jhu.edu

Meagan Clemence, Study Coordinator, M.Ed

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 4, 2026

Study Start (Estimated)

January 4, 2027

Primary Completion (Estimated)

November 30, 2030

Study Completion (Estimated)

March 31, 2031

Last Updated

September 4, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

The scientific data and metadata generated by this project will be archived in a publicly accessible repository that meets recognized standards for data sharing and preservation. The investigators will deposit the data and metadata in open Inter-university Consortium for Political and Social Research (ICPSR) data repository.

Shared Documents
STUDY PROTOCOL

Locations

US(2)