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Recruiting NCT07593729

Nurse-Led Caregiver Support Program in Home Palliative Care

No phase Interventional Palliative Care Caregiver Burden Home Care

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nurse-Led Caregiver Support Program.
Who it may be relevant to
Registry conditions: Palliative Care, Caregiver Burden, Home Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Nurse-Led Caregiver Support Program
    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.

Primary outcome measures

  • Care Competency Scale for Family Caregivers in Home Palliative Care [Time frame: Baseline, post-intervention at 6 weeks, and 3-month follow-up]
Secondary outcome measures (5)
  • Zarit Burden Interview [Time frame: Baseline, post-intervention at 6 weeks, and 3-month follow-up]
  • General Self-Efficacy Scale [Time frame: Baseline, post-intervention at 6 weeks, and 3-month follow-up]
  • Integrated Palliative Care Outcome Scale [Time frame: Baseline, post-intervention at 6 weeks, and 3-month follow-up]
  • Emergency Department Visits [Time frame: Baseline, post-intervention at 6 weeks, and 3-month follow-up]
  • Hospitalizations [Time frame: During the 3-month follow-up period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Simav Doc. Dr. Ismail Karakuyu State Hospital — Simav

Publications

  • 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. PMID 33785083
  • 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. PMID 40521035
  • 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. PMID 38310666

Identifiers

NCT: NCT07593729 · KSBU-HPC-RCT-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗