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Nurse-Led Caregiver Support Program in Home Palliative Care (CARE-PAL)

2026年7月24日 更新者:Kutahya Health Sciences University

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

This randomized controlled trial aims to evaluate the effect of a nurse-led caregiver support program on caregiver competency and healthcare utilization among family caregivers of patients receiving home palliative care. Family caregivers in the intervention group will receive a structured 6-week nurse-led support program including face-to-face education, weekly telephone coaching, caregiver guidance materials, and decision support for symptom management and healthcare utilization. The control group will continue to receive routine home palliative care services. Primary outcome is caregiver competency. Secondary outcomes include caregiver burden, self-efficacy, patient symptom burden, emergency department visits, and hospitalizations.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
无干预:Routine Home Palliative Care
Participants will receive routine home palliative care services.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Care Competency Scale for Family Caregivers in Home Palliative Care
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Zarit Burden Interview
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月12日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年9月30日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月11日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月24日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Individual participant data sharing plans have not yet been determined. Data sharing decisions will be made after study completion in accordance with institutional policies and ethical considerations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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