Nurse-Led Caregiver Support Program in Home Palliative Care (CARE-PAL)
Effect of a Nurse-Led Caregiver Support Program on Caregiver Competency and Healthcare Utilization Among Family Caregivers in Home Palliative Care: A Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Palliative care aims to improve quality of life for individuals with life-threatening illnesses through symptom management and holistic care. In home palliative care settings, family caregivers play a critical role in providing daily care and symptom monitoring. However, caregiving responsibilities may lead to increased burden, stress, and inappropriate healthcare utilization.
This study is designed as a single-center, parallel-group, randomized controlled trial to evaluate the effectiveness of a nurse-led caregiver support program among family caregivers of patients receiving home palliative care services.
A total of 150 family caregivers will be recruited and randomized into intervention and control groups in a 1:1 ratio using computer-generated block randomization. Participants in the intervention group will receive a structured 6-week nurse-led caregiver support program consisting of an initial face-to-face educational session and weekly telephone coaching. Intervention content includes symptom management, daily care skills, medication management, complication recognition, caregiver self-care, stress management, and healthcare utilization decision support. Caregivers will also receive a caregiver guidebook and crisis management decision algorithm.
Participants in the control group will continue receiving routine home palliative care services without additional structured support.
Outcome assessments will be conducted at baseline (T0), post-intervention (T1), and 3-month follow-up (T2). The primary outcome is caregiver competency measured using the Care Competency Scale for Family Caregivers in Home Palliative Care. Secondary outcomes include caregiver burden, self-efficacy, patient symptom burden, emergency department visits, and hospitalizations.
The study is expected to provide evidence regarding the effectiveness of nurse-led caregiver support interventions in home palliative care settings.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Serkan Budak, PhD / RN
- Número de teléfono: +905385430616
- Correo electrónico: serkan.budak@ksbu.edu.tr
Ubicaciones de estudio
-
-
Kütahya
-
Simav, Kütahya, Turquía (Türkiye), 43500
- Reclutamiento
- Simav Doc. Dr. Ismail Karakuyu State Hospital
-
Contacto:
- Veli Arslan, RN
- Número de teléfono: +902745137048
- Correo electrónico: kutahyadhs10@saglik.gov.tr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult family caregivers of patients receiving home palliative care services
- Age 18 years or older
- Being the primary caregiver responsible for the patient's daily care
- Ability to communicate in Turkish
- Willingness to participate in the study
Exclusion Criteria:
- Professional or paid caregivers
- Caregivers with severe cognitive impairment or severe psychiatric disorders
- Inability to participate in follow-up assessments
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Nurse-Led Caregiver Support Program
Participants will receive a structured nurse-led caregiver support program in addition to routine home palliative care services.
|
Participants in the intervention group will receive a structured 6-week nurse-led caregiver support program including face-to-face education, weekly telephone coaching, caregiver guidance materials, symptom management support, medication management education, stress management strategies, and healthcare utilization decision support in addition to routine home palliative care services.
|
|
Sin intervención: Routine Home Palliative Care
Participants will receive routine home palliative care services.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Care Competency Scale for Family Caregivers in Home Palliative Care
Periodo de tiempo: Baseline, post-intervention at 6 weeks, and 3-month follow-up
|
Caregiver competency will be assessed using the Care Competency Scale for Family Caregivers in Home Palliative Care.
The scale includes 29 items scored on a 1-5 Likert scale.
Total scores range from 29 to 145, with higher scores indicating greater caregiver competency.
|
Baseline, post-intervention at 6 weeks, and 3-month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Zarit Burden Interview
Periodo de tiempo: Baseline, post-intervention at 6 weeks, and 3-month follow-up
|
Caregiver burden will be assessed using the Zarit Burden Interview.
Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.
|
Baseline, post-intervention at 6 weeks, and 3-month follow-up
|
|
General Self-Efficacy Scale
Periodo de tiempo: Baseline, post-intervention at 6 weeks, and 3-month follow-up
|
Caregiver self-efficacy will be assessed using the General Self-Efficacy Scale.
Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.
|
Baseline, post-intervention at 6 weeks, and 3-month follow-up
|
|
Integrated Palliative Care Outcome Scale
Periodo de tiempo: Baseline, post-intervention at 6 weeks, and 3-month follow-up
|
Patient symptom burden will be assessed using the Integrated Palliative Care Outcome Scale proxy version.
Total scores range from 0 to 68, with higher scores indicating greater symptom burden and unmet needs.
|
Baseline, post-intervention at 6 weeks, and 3-month follow-up
|
|
Emergency Department Visits
Periodo de tiempo: Baseline, post-intervention at 6 weeks, and 3-month follow-up
|
Emergency department visits will be assessed as the number of emergency department visits during the follow-up period.
Higher values indicate greater emergency healthcare utilization.
|
Baseline, post-intervention at 6 weeks, and 3-month follow-up
|
|
Hospitalizations
Periodo de tiempo: During the 3-month follow-up period
|
Hospitalizations will be assessed as the number of hospital admissions during the follow-up period.
Higher values indicate greater inpatient healthcare utilization.
|
During the 3-month follow-up period
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Karabulutlu EY, Turan GB, Yanmis S. Evaluation of care burden and preparedness of caregivers who provide care to palliative care patients. Palliat Support Care. 2022 Feb;20(1):30-37. doi: 10.1017/S1478951521000213.
- Wang T, Kong J, Chen X, Yang Y, Liu D, Liu T, Li L. Development and psychometric assessment of a care competency scale for family caregivers in home palliative care. Asia Pac J Oncol Nurs. 2025 May 10;12:100719. doi: 10.1016/j.apjon.2025.100719. eCollection 2025 Dec.
- Zhang Y, Li J, Zhang Y, Chen C, Guan C, Zhou L, Zhang S, Chen X, Hu X. Mediating effect of social support between caregiver burden and quality of life among family caregivers of cancer patients in palliative care units. Eur J Oncol Nurs. 2024 Feb;68:102509. doi: 10.1016/j.ejon.2024.102509. Epub 2024 Jan 15.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KSBU-HPC-RCT-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .