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

ConditionsHeart FailureCaregiver
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: HEROIC programExperimental treatment 1 intervention
Group B: Control conditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

Number of unplanned acute care (patient) visits

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

Time frame
1 year

Secondary outcomes

1

Caregiver burden as assessed by Zarit Burden Interview

Zarit Burden Interview, 13 item version. Scores range from 0-48 with higher scores indicating worse burden.

Time frame
12 weeks
2

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

Coping Self-efficacy. 13 items. Scores range from 0-130 with higher scores indicating better self-efficacy.

Time frame
12 weeks
3

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

Heart Failure Self-Care Index, version 8.0, 23 items. The Heart Failure Self-Care Index uses three separate subscales scored and standardized on a 0 to 100 scale, where 70 or higher indicates adequate self-care.

Time frame
12 weeks
4

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

Integrated Palliative Outcomes Scale (iPOS), 10 items. Scores range from 0-40 with higher scores indicating higher unmet needs.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: