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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Serkan Budak, PhD / RN
- 電話番号：+905385430616
- メール：serkan.budak@ksbu.edu.tr
研究場所
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Kütahya
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Simav、Kütahya、トルコ（Türkiye）、43500
- 募集
- Simav Doc. Dr. Ismail Karakuyu State Hospital
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コンタクト：
- Veli Arslan, RN
- 電話番号：+902745137048
- メール：kutahyadhs10@saglik.gov.tr
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：Routine Home Palliative Care
Participants will receive routine home palliative care services.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Care Competency Scale for Family Caregivers in Home Palliative Care
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Zarit Burden Interview
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- KSBU-HPC-RCT-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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