Nurse-Led Caregiver Support Program in Home Palliative Care: A Randomized Controlled Trial (CARE-PAL)

May 11, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants will receive a structured nurse-led caregiver support program in addition to routine home palliative care services.
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.
No Intervention: Control Group
Participants will receive routine home palliative care services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Competency
Time Frame: 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.
Baseline, post-intervention at 6 weeks, and 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Burden
Time Frame: Baseline, post-intervention at 6 weeks, and 3-month follow-up
Caregiver burden will be assessed using the Zarit Burden Interview.
Baseline, post-intervention at 6 weeks, and 3-month follow-up
Caregiver Self-Efficacy
Time Frame: Baseline, post-intervention at 6 weeks, and 3-month follow-up
Caregiver self-efficacy will be evaluated using a caregiver self-efficacy assessment tool.
Baseline, post-intervention at 6 weeks, and 3-month follow-up
Patient Symptom Burden
Time Frame: Baseline, post-intervention at 6 weeks, and 3-month follow-up
Patient symptom burden will be evaluated using a symptom assessment tool.
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
Number of emergency department visits during the study period.
Baseline, post-intervention at 6 weeks, and 3-month follow-up
Hospitalizations
Time Frame: During the 3-month follow-up period
Number of hospitalizations during the study period.
During the 3-month follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 12, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSBU-HPC-RCT-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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