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NCT Number: NCT07593729

Nurse-Led Caregiver Support Program in Home Palliative Care

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.

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Key information

Conditions

Palliative Care Behavior Behavioral Symptoms Caregiver Burden Home Care Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Simav Doc. Dr. Ismail Karakuyu State Hospital

Simav, Kütahya, 43500, Turkey (Türkiye)

Location status: Recruiting

Location contact

Veli Arslan, RN

CONTACT

[email protected]

+902745137048

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Care Competency Scale for Family Caregivers in Home Palliative Care

    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. 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.

Secondary outcomes

  1. Zarit Burden Interview

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

    Caregiver burden will be assessed using the Zarit Burden Interview. Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.

  2. General Self-Efficacy Scale

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

    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.

  3. Integrated Palliative Care Outcome Scale

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

    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.

  4. Emergency Department Visits

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

    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.

  5. Hospitalizations

    Time frame: During the 3-month follow-up period

    Hospitalizations will be assessed as the number of hospital admissions during the follow-up period. Higher values indicate greater inpatient healthcare utilization.

Study contacts

Contact information is provided by the study sponsor or research team.

Serkan Budak, PhD / RN

CONTACT

[email protected]

+905385430616

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study 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

Acronym: CARE-PAL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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