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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse-Led Caregiver Support Program | Experimental | Participants will receive a structured nurse-led caregiver support program in addition to routine home palliative care services. |
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| Routine Home Palliative Care | No Intervention | Participants will receive routine home palliative care services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-Led Caregiver Support Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Care Competency Scale for Family Caregivers in Home Palliative Care | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Zarit Burden Interview | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serkan Budak, PhD / RN | Contact | +905385430616 | serkan.budak@ksbu.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simav Doc. Dr. Ismail Karakuyu State Hospital | Simav | Kütahya | 43500 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33785083 | Background | 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. | |
| 40521035 | Background | 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. |
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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.
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Participants will be randomized into intervention and control groups in a 1:1 ratio.
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Outcome assessors and data analysts will be blinded to group allocation during data analysis.
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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. |
| Baseline, post-intervention at 6 weeks, and 3-month follow-up |
| Integrated Palliative Care Outcome Scale | 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 | 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 | 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 |
| 38310666 | Background | 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. |