- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07434440
Nurse-Led Psychoeducation for Caregivers Receiving Home Health Care (N-PRO CARE) (N-PRO CARE)
The Effect of a Nurse-Led Psychoeducation Programme for Caregivers of Patients Receiving Home Health Care on Self-Efficacy and Psychological Resilience: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Caregivers of patients receiving home health care often face physical, emotional, and psychosocial challenges that may negatively affect their well-being and caregiving capacity. Strengthening caregivers' psychological resources, such as self-efficacy and psychological resilience, is essential for improving both caregiver outcomes and the quality of care provided to patients.
This study was designed as a randomized controlled trial to evaluate the effectiveness of a structured, nurse-led psychoeducation programme delivered to caregivers of patients receiving home health care. A total of 42 caregivers were randomly allocated to an intervention group or a control group. The intervention group received a six-week psychoeducation programme consisting of weekly individual sessions lasting approximately 45 minutes, delivered in the home setting. The programme included education on caregiving skills, infection control, nutrition and mobilization, pressure injury prevention, urinary catheter care, as well as strategies to enhance self-efficacy and psychological resilience.
The control group received routine home health care services without additional psychoeducation. Data were collected using a Personal Information Form, the General Self-Efficacy Scale, and the Adult Psychological Resilience Scale at baseline and one week after completion of the intervention. The primary outcomes of the study were changes in caregivers' self-efficacy and psychological resilience levels following the psychoeducation programme.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Amasra
-
Bartın, Amasra, Turkey (Türkiye), 74100
- A State Hospital Home Health Care Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Formal caregivers (e.g., paid caregivers, nurses)
- Individuals with communication impairments
- Caregivers who did not meet the inclusion criteria
- Withdrawal from the study during the intervention period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group (Nurse-Led Psychoeducation)
Caregivers assigned to the intervention group received a structured nurse-led psychoeducation programme in addition to usual home health care services.
|
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.
|
|
Other: Control Group (Usual Care)
Caregivers assigned to the control group received routine home health care services without any additional psychoeducation intervention.
|
the control group received usual care only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy
Time Frame: Baseline and 1 week after completion of the intervention
|
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
Time Frame: Baseline and 1 week after completion of the intervention
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sakine Fırıncık, PhD, Karabuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/1140
- No secondary identifier assign (Other Identifier: No secondary identifier assigned)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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