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

1 settembre 2026 aggiornato da: Johns Hopkins University
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).

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

500

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Martha Abshire Saylor, Principal Investigator, PhD, RN
  • Numero di telefono: HEROIC phone number
  • Email: mabshir1@jhu.edu

Backup dei contatti dello studio

  • Nome: Meagan Clemence, Study Coordinator, M.Ed

Luoghi di studio

    • Colorado
      • Denver, Colorado, Stati Uniti, 80217
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21205
        • Johns Hopkins University, School of Nursing
        • Contatto:
          • Martha Abshire Saylor, PhD
          • Numero di telefono: 443-340-6201
          • Email: mabshir1@jhu.edu
        • Investigatore principale:
          • Martha Abshire Saylor, PhD
        • Sub-investigatore:
          • Colleen McIlvennan, PhD, DNP, ANP

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: HEROIC program
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).
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).
Altri nomi:
  • Caregiver Support
Comparatore attivo: Control condition
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 .

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36)
Lasso di tempo: 12 weeks
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)
Lasso di tempo: 12 weeks
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
Lasso di tempo: 1 year
number of unplanned hospitalization, emergency room visit, urgent care and unscheduled/same-day visits
1 year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Caregiver burden as assessed by Zarit Burden Interview
Lasso di tempo: 12 weeks
Zarit Burden Interview, 13 item version. Scores range from 0-48 with higher scores indicating worse burden.
12 weeks
Self-efficacy (caregiver) assessed by Coping Self-Efficacy Scale (CSE)
Lasso di tempo: 12 weeks
Coping Self-efficacy. 13 items. Scores range from 0-130 with higher scores indicating better self-efficacy.
12 weeks
Self-care (patient) as assessed by the Heart Failure Self-Care Index
Lasso di tempo: 12 weeks
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.
12 weeks
Palliative Care Needs as assessed by the Integrated Palliative Outcomes Scale (iPOS)
Lasso di tempo: 12 weeks
Integrated Palliative Outcomes Scale (iPOS), 10 items. Scores range from 0-40 with higher scores indicating higher unmet needs.
12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Martha Abshire Saylor, PhD, RN, Johns Hopkins University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

4 gennaio 2027

Completamento primario (Stimato)

30 novembre 2030

Completamento dello studio (Stimato)

31 marzo 2031

Date di iscrizione allo studio

Primo inviato

1 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 settembre 2026

Primo Inserito (Effettivo)

4 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB00568390
  • 1R01HL183346 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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