- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07593729
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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Serkan Budak, PhD / RN
- 전화번호: +905385430616
- 이메일: serkan.budak@ksbu.edu.tr
연구 장소
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Kütahya
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Simav, Kütahya, 터키 (Türkiye), 43500
- 모병
- Simav Doc. Dr. Ismail Karakuyu State Hospital
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연락하다:
- Veli Arslan, RN
- 전화번호: +902745137048
- 이메일: kutahyadhs10@saglik.gov.tr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: Routine Home Palliative Care
Participants will receive routine home palliative care services.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Care Competency Scale for Family Caregivers in Home Palliative Care
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Zarit Burden Interview
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KSBU-HPC-RCT-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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