- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07805811
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
Condiciones
Intervención / Tratamiento
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
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Colorado
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Denver, Colorado, Estados Unidos, 80217
- University of Colorado Anschutz
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Contacto:
- Colleen McIlvennan,, PhD, DNP, ANP
- Número de teléfono: 920-540-0809
- Correo electrónico: Colleen.McIlvennan@cuanschutz.edu
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins University, School of Nursing
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Contacto:
- Martha Abshire Saylor, PhD
- Número de teléfono: 443-340-6201
- Correo electrónico: mabshir1@jhu.edu
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Investigador principal:
- Martha Abshire Saylor, PhD
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Sub-Investigador:
- Colleen McIlvennan, PhD, DNP, ANP
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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
- 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)
- If ventricular assist device: > 1 month since implant AND ambulatory/outpatient
- 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:
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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:
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¿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.
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12 weeks
|
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Health-related quality of Life (patient) as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Periodo de tiempo: 12 weeks
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Kansas City Cardiomyopathy Questionnaire (KCCQ), 12 item version.
Scoring is from 0 to 100 where higher scores indicate better health-related quality of life.
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12 weeks
|
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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
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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.
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12 weeks
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Self-efficacy (caregiver) assessed by Coping Self-Efficacy Scale (CSE)
Periodo de tiempo: 12 weeks
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Coping Self-efficacy.
13 items.
Scores range from 0-130 with higher scores indicating better self-efficacy.
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12 weeks
|
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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.
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12 weeks
|
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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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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.
Publicaciones Generales
- 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.
- 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.
- 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.
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
Palabras clave
Términos MeSH relevantes adicionales
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. .