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

1 de septiembre de 2026 actualizado 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).

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

500

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Martha Abshire Saylor, Principal Investigator, PhD, RN
  • Número de teléfono: HEROIC phone number
  • Correo electrónico: mabshir1@jhu.edu

Copia de seguridad de contactos de estudio

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

Ubicaciones de estudio

    • Colorado
      • Denver, Colorado, Estados Unidos, 80217
        • University of Colorado Anschutz
        • Contacto:
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21205
        • Johns Hopkins University, School of Nursing
        • Contacto:
          • Martha Abshire Saylor, PhD
          • Número de teléfono: 443-340-6201
          • Correo electrónico: mabshir1@jhu.edu
        • Investigador principal:
          • Martha Abshire Saylor, PhD
        • Sub-Investigador:
          • Colleen McIlvennan, PhD, DNP, ANP

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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).
Otros nombres:
  • Caregiver Support
Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Caregiver burden as assessed by Zarit Burden Interview
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

4 de enero de 2027

Finalización primaria (Estimado)

30 de noviembre de 2030

Finalización del estudio (Estimado)

31 de marzo de 2031

Fechas de registro del estudio

Enviado por primera vez

1 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Publicado por primera vez (Actual)

4 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB00568390
  • 1R01HL183346 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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 información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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