AzTrials
AzTrials

Heart FailurePhase 2NCT07805811

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

A Phase 2 study testing HEROIC program in people with Heart Failure and Caregiver, run by Johns Hopkins University at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Caregiver
What is being tested?
HEROIC program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
2 sitesUnited States
Study dates
4 Jan 2027to 31 Mar 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Martha Abshire Saylor, Principal Investigator, PhD, RN contact

HEROIC phone number

mabshir1@jhu.edu

Meagan Clemence, Study Coordinator, M.Ed contact

United States2 sites

  • Johns Hopkins University, School of Nursing

    Baltimore, Maryland, 21205

    Martha Abshire Saylor, PhD, 443-340-6201, mabshir1@jhu.edu

    Martha Abshire Saylor, PhD

  • University of Colorado Anschutz

    Denver, Colorado, 80217

    Colleen McIlvennan,, PhD, DNP, ANP, 920-540-0809, Colleen.McIlvennan@cuanschutz.edu

Other trials in United States

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).

Read the detailed description

Heart failure (HF) is a major source of suffering, the leading cause of death in the US (higher than dementia and cancer combined) and results in $108 billion annually in global health care costs to individuals, families and communities. Policies limiting reimbursement for HF readmissions increase strain on family caregivers to manage HF in the home with very little support. Despite advancements in guideline-directed medical therapies, HF patient outcomes are worse than the prior decade - including higher readmissions and mortality. Increased uptake of advanced HF surgical therapies including durable ventricular assist device and heart transplantation improve patient health-related quality of life (HRQOL) and survival but require high involvement of family caregivers. The impact of advanced HF care and policy falls on family caregivers who bear increased tasks and responsibilities over time while saving health systems over 7 billion per year. Caregiving for persons with HF, regardless of advanced therapies, is associated with worsening caregiver mental health, burden, stress, loss of social connections, disruptions to work, and increased financial strain. 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. 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). The investigators now propose to conduct a mechanistic randomized controlled trial to test HEROIC mechanisms of action for caregivers (N=250) and persons with advanced HF for whom the caregivers provide care, including those treated medically, or with ventricular assist device or heart transplantation (N=250) in two health systems. Aim 1 focuses on caregiver self-efficacy and burden as mechanisms of action by which HEROIC improves caregiver mental health at 12 and maintenance at 24 weeks. Aim 2 focuses on patient mechanisms - increases in HF self-care and reductions in unmet palliative care needs as mediators of improvement in patient HRQOL at 12 and 24 weeks and unplanned acute care at 1 year. Aim 3 explores differences in mechanisms and response to intervention components by HF subgroup. The investigators will recruit a Patient and Family Advisory Council to guide the trial and intervention delivery. An exceptional study team with expertise in intersecting fields of research including HF, caregiving, and mixed methods research will guide the study. This innovative proposal directly responds to HF guidelines, policy initiatives and National Heart, Lung, and Blood Institute (NHLBI) strategic priorities, including Grant Notice "NOT-HL-23-117" Palliative Care in the Care Continuum, and will provide evidence of a powerful primary palliative care strategy to demonstrate how HEROIC works (mechanisms) so that it can be scaled and adapted across settings and populations.

Being tested
HEROIC program, Active Comparator Control 1
Keywords
heart failure, caregiving, support program, palliative care, heart transplant, ventricular assist device
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HEROIC programBehavioural

    Also called Caregiver Support

    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 1Behavioural

    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.
Study groups in NCT07805811
Study groupRoleWhat they receive
HEROIC programExperimentalThe 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).
Receives: Behavioral: HEROIC program
Control conditionActive comparatorThe 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 .
Receives: Behavioral: Active Comparator Control 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 12 weeks

  3. Number of unplanned acute care (patient) visits

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

    Measured: 1 year

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2026
  2. Study start4 Jan 2027 (estimated)
  3. Primary completion30 Nov 2030 (estimated)
  4. Study completion31 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07805811
Sponsor's protocol ID
IRB00568390
Other IDs
1R01HL183346
Status last verified
Sep 2026
First submitted
1 Sep 2026
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37059045

  • 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.

    PubMed 37707361

  • 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.

    PubMed 35602009

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HEROIC program in people with Heart Failure and Caregiver, run by Johns Hopkins University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martha Abshire Saylor, Principal Investigator, PhD, RN (HEROIC phone number, mabshir1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07805811, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in