Testing Heart Failure Resilience Intervention for Caregivers (HEROIC) in Advanced Heart Failure
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Travel or expenses covered
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 10 weeks
- Procedures mentioned: Phone or video check-ins
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The HEart Failure Resilience Intervention for Caregivers (HEROIC) is a theory- and evidence-based primary palliative intervention including 5 individualized nurse-led sessions conducted over 10 weeks via video calls."
- Compensation
- Travel or expenses covered
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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 1. 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) 2. If ventricular assist device: \> 1 month since implant AND ambulatory/outpatient 3. If heart transplant: \> 1 month since Heart Transplant (HTx) AND ambulatory/outpatient Exclusion Criteria: * Patients and caregivers who screen positive for severe cognitive impairment Telephone Interview for Cognitive Screening (TICS-M) will be excluded.
Study sites (2)
CO
- University of Colorado Anschutz · Denver, CO 80217Colleen McIlvennan,, PhD, DNP, ANP · Study contact · 920-540-0809 · Colleen.McIlvennan@cuanschutz.eduMore trials in Denver
MD
- Johns Hopkins University, School of Nursing · Baltimore, MD 21205Martha Abshire Saylor, PhD · Study contact · 443-340-6201 · mabshir1@jhu.eduMartha Abshire Saylor, PhD · Principal investigatorColleen McIlvennan, PhD, DNP, ANP · Sub-investigatorMore trials in Baltimore