HEROIC Program for Heart Failure

Not yet recruiting at 1 trial location
MA
MC
Overseen ByMeagan Clemence, Study Coordinator, M.Ed
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

MA

Martha Abshire Saylor, PhD, RN

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people with advanced heart failure and their caregivers. Participants may have a ventricular assist device, have had a heart transplant, or be managing heart failure medically. Both patients and their main caregivers can join.

Inclusion Criteria

Caregiver Inclusion Criteria: Score of 5 or more on the Zarit Burden Interview
I am over 18 years old.
Patient Inclusion Criteria: Reports needing help with at least one activity of daily living or instrumental activity of daily living
See 10 more

Exclusion Criteria

Patients and caregivers who screen positive for severe cognitive impairment on Telephone Interview for Cognitive Screening (TICS-M)

What Are the Treatments Tested in This Trial?

Interventions

  • HEROIC program

Trial Overview

The study compares the HEROIC program—a nurse-led support intervention designed to help caregivers cope—with standard care. It aims to see if HEROIC improves caregiver mental health, patient quality of life, and reduces emergency hospital visits.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: HEROIC programExperimental Treatment1 Intervention
Group II: Control conditionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+