Caregiver Burden, Home Care, Palliative Care
Conditions
Keywords
Nurse-led intervention, Family caregiver, Caregiver competency, Home care, Randomized controlled trial, Palliative care, Healthcare utilization
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.
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
BEHAVIORALNurse-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.
Sponsors
Kutahya Health Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors and data analysts will be blinded to group allocation during data analysis.
Intervention model description
Participants will be randomized into intervention and control groups in a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Care Competency Scale for Family Caregivers in Home Palliative Care | 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
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview | 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. |
| General Self-Efficacy Scale | 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. |
| Integrated Palliative Care Outcome Scale | 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. |
| Emergency Department Visits | 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. |
| Hospitalizations | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSerkan Budak, PhD / RN
Outcome results
None listed