Nurse-Led Caregiver Support Program in Home Palliative Care: A Randomized Controlled Trial

NCT07593729 | Not Yet Recruiting

• 1 other identifier: KSBU-HPC-RCT-2026-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Palliative Care; Caregiver Burden; Home Care

Keywords

Nurse-led intervention; Family caregiver; Caregiver competency; Home care; Randomized controlled trial; Palliative care; Healthcare utilization

Outcome Measures

Primary Outcomes (1)

• Caregiver Competency

  Caregiver competency will be assessed using the Care Competency Scale for Family Caregivers in Home Palliative Care.

  Baseline, post-intervention at 6 weeks, and 3-month follow-up

Secondary Outcomes (5)

• Caregiver Burden

  Baseline, post-intervention at 6 weeks, and 3-month follow-up

• Caregiver Self-Efficacy

  Baseline, post-intervention at 6 weeks, and 3-month follow-up

• Patient Symptom Burden

  Baseline, post-intervention at 6 weeks, and 3-month follow-up

• Emergency Department Visits

  Baseline, post-intervention at 6 weeks, and 3-month follow-up

• Hospitalizations

  During the 3-month follow-up period

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will receive a structured nurse-led caregiver support program in addition to routine home palliative care services.

Behavioral: Nurse-Led Caregiver Support Program

Control Group

NO INTERVENTION

Participants will receive routine home palliative care services.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Professional or paid caregivers
• Caregivers with severe cognitive impairment or severe psychiatric disorders
• Inability to participate in follow-up assessments

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Simav Doc. Dr. Ismail Karakuyu State Hospital

Simav, Kütahya, 43500, Turkey (Türkiye)

Location

Related Publications (3)

• 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 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.

  PMID: 40521035 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.

  PMID: 38310666 BACKGROUND

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Serkan Budak, PhD / RN

CONTACT

+905385430616; serkan.budak@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to group allocation during data analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into intervention and control groups in a 1:1 ratio.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

TU (1)