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
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Serkan Budak, PhD / RN
- Номер телефона: +905385430616
- Электронная почта: serkan.budak@ksbu.edu.tr
Места учебы
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Kütahya
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Simav, Kütahya, Турция (Туркие), 43500
- Рекрутинг
- Simav Doc. Dr. Ismail Karakuyu State Hospital
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Контакт:
- Veli Arslan, RN
- Номер телефона: +902745137048
- Электронная почта: kutahyadhs10@saglik.gov.tr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Nurse-Led Caregiver Support Program
Participants will receive a structured nurse-led caregiver support program in addition to routine home palliative care services.
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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.
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Без вмешательства: Routine Home Palliative Care
Participants will receive routine home palliative care services.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Care Competency Scale for Family Caregivers in Home Palliative Care
Временное ограничение: Baseline, post-intervention at 6 weeks, and 3-month follow-up
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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.
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Baseline, post-intervention at 6 weeks, and 3-month follow-up
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Zarit Burden Interview
Временное ограничение: Baseline, post-intervention at 6 weeks, and 3-month follow-up
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Caregiver burden will be assessed using the Zarit Burden Interview.
Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.
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Baseline, post-intervention at 6 weeks, and 3-month follow-up
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General Self-Efficacy Scale
Временное ограничение: Baseline, post-intervention at 6 weeks, and 3-month follow-up
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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.
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Baseline, post-intervention at 6 weeks, and 3-month follow-up
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Integrated Palliative Care Outcome Scale
Временное ограничение: Baseline, post-intervention at 6 weeks, and 3-month follow-up
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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.
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Baseline, post-intervention at 6 weeks, and 3-month follow-up
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Emergency Department Visits
Временное ограничение: Baseline, post-intervention at 6 weeks, and 3-month follow-up
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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.
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Baseline, post-intervention at 6 weeks, and 3-month follow-up
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Hospitalizations
Временное ограничение: During the 3-month follow-up period
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Hospitalizations will be assessed as the number of hospital admissions during the follow-up period.
Higher values indicate greater inpatient healthcare utilization.
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During the 3-month follow-up period
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KSBU-HPC-RCT-2026-01
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .