NCT07434440

Brief Summary

This randomized controlled trial aimed to examine the effect of a nurse-led psychoeducation programme on self-efficacy and psychological resilience among caregivers of patients receiving home health care. Caregivers were randomly assigned to either an intervention group receiving a structured psychoeducation programme or a control group receiving usual care. Outcomes were assessed at baseline and one week after completion of the intervention using validated measurement tools.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 26, 2026

Last Update Submit

February 20, 2026

Conditions

Caregiver BurdenPsychological ResilienceSelf-Efficacy

Keywords

Home health careCaregiversPsychoeducationNurse-led interventionSelf-efficacyPsychological resilienceRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Self-Efficacy

    Self-efficacy levels of caregivers were assessed using the General Self-Efficacy Scale, a validated self-report instrument measuring individuals' perceived ability to cope with challenging situations.

    Baseline and 1 week after completion of the intervention

  • Psychological Resilience

    Psychological resilience levels of caregivers were assessed using the Adult Psychological Resilience Scale, a validated self-report instrument evaluating individuals' capacity to adapt positively to stress and adversity.

    Baseline and 1 week after completion of the intervention

Study Arms (2)

Intervention Group (Nurse-Led Psychoeducation)

EXPERIMENTAL

Caregivers assigned to the intervention group received a structured nurse-led psychoeducation programme in addition to usual home health care services.

Behavioral: Nurse-Led Psychoeducation Programme

Control Group (Usual Care)

OTHER

Caregivers assigned to the control group received routine home health care services without any additional psychoeducation intervention.

Other: routine follow-up

Interventions

Nurse-Led Psychoeducation ProgrammeBEHAVIORAL

The nurse-led psychoeducation programme was delivered individually to caregivers of patients receiving home health care. The programme consisted of six weekly sessions, each lasting approximately 45 minutes, conducted in the patient's home. The content included education and practical training on home health care services, infection control, nutrition and mobilization, pressure injury prevention, urinary catheter care, and strategies to enhance caregivers' self-efficacy and psychological resilience.

Intervention Group (Nurse-Led Psychoeducation)
routine follow-upOTHER

the control group received usual care only

Control Group (Usual Care)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Providing care to a patient receiving home health care for at least two months
  • Able to read and write
  • No communication barriers
  • Actively receiving home health care services for the patient
  • No diagnosed psychiatric disorder
  • Informal caregiver (not a formal caregiver such as a paid caregiver or nurse)
  • Willing to participate in the study and provide informed consent

You may not qualify if:

  • Formal caregivers (e.g., paid caregivers, nurses)
  • Individuals with communication impairments
  • Withdrawal from the study during the intervention period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A State Hospital Home Health Care Unit

Bartın, Amasra, 74100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Sakine Fırıncık, PhD

    Karabuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study used a parallel-group randomized controlled design. Eligible caregivers were randomly assigned to either an intervention group receiving a nurse-led psychoeducation programme or a control group receiving usual care. The intervention and control conditions were implemented concurrently, and outcomes were assessed at baseline and after completion of the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Prof.

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 25, 2026

Study Start

December 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

For ethical reasons, individual patient data will not be shared.

Locations

TU(1)