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

1 de setembro de 2026 atualizado por: 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).

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

500

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Martha Abshire Saylor, Principal Investigator, PhD, RN
  • Número de telefone: HEROIC phone number
  • E-mail: mabshir1@jhu.edu

Estude backup de contato

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

Locais de estudo

    • Colorado
      • Denver, Colorado, Estados Unidos, 80217
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21205
        • Johns Hopkins University, School of Nursing
        • Contato:
          • Martha Abshire Saylor, PhD
          • Número de telefone: 443-340-6201
          • E-mail: mabshir1@jhu.edu
        • Investigador principal:
          • Martha Abshire Saylor, PhD
        • Subinvestigador:
          • Colleen McIlvennan, PhD, DNP, ANP

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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).
Outros nomes:
  • Caregiver Support
Comparador Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36)
Prazo: 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)
Prazo: 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
Prazo: 1 year
number of unplanned hospitalization, emergency room visit, urgent care and unscheduled/same-day visits
1 year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Caregiver burden as assessed by Zarit Burden Interview
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 12 weeks
Integrated Palliative Outcomes Scale (iPOS), 10 items. Scores range from 0-40 with higher scores indicating higher unmet needs.
12 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Martha Abshire Saylor, PhD, RN, Johns Hopkins University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

4 de janeiro de 2027

Conclusão Primária (Estimado)

30 de novembro de 2030

Conclusão do estudo (Estimado)

31 de março de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

1 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de setembro de 2026

Primeira postagem (Real)

4 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • IRB00568390
  • 1R01HL183346 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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 de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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