Caregiver BurdenN-PRO CARENCT07434440
Nurse-Led Psychoeducation for Caregivers Receiving Home Health Care (N-PRO CARE)
A study testing Nurse-Led Psychoeducation Programme and routine follow-up in people with Caregiver Burden and Psychological Resilience, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden, Psychological Resilience, Self-Efficacy
- What is being tested?
- Nurse-Led Psychoeducation Programme and routine follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
A State Hospital Home Health Care Unit
Bartın, Amasra, 74100
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Caregiver Burden, Psychological Resilience, Self-Efficacy
- Being tested
- Nurse-Led Psychoeducation Programme, routine follow-up
- Keywords
- Home health care, Caregivers, Psychoeducation, Nurse-led intervention, Self-efficacy, Psychological resilience, Randomized controlled trial
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Psychoeducation ProgrammeBehavioural
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.
routine follow-upOther
the control group received usual care only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: routine follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 1 week after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Dec 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sakine Firincik, Karabuk University
- Investigators
- Sakine Fırıncık, PhD, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434440
- Sponsor's protocol ID
- 2022/1140
- Other IDs
- No secondary identifier assign
- Acronym
- N-PRO CARE
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For ethical reasons, individual patient data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07434440
- Acronym / sponsor ID
- N-PRO CARE / 2022/1140
- Conditions
- Caregiver Burden, Psychological Resilience, Self-Efficacy
- Keywords
- Home health care, Caregivers, Psychoeducation, Nurse-led intervention, Self-efficacy, Psychological resilience, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Nurse-Led Psychoeducation) | Experimental | Behavioral: Nurse-Led Psychoeducation ProgrammeCaregivers assigned to the intervention group received a structured nurse-led psychoeducation programme in addition to usual home health care services. |
| Control Group (Usual Care) | Other | Other: routine follow-upCaregivers assigned to the control group received routine home health care services without any additional psychoeducation intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Led Psychoeducation ProgrammeThe 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. | Behavioural | Intervention Group (Nurse-Led Psychoeducation) |
| routine follow-upthe control group received usual care only | Other | Control Group (Usual Care) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No. For ethical reasons, individual patient data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sakine Fırıncık, PhD principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Psychoeducation Programme and routine follow-up in people with Caregiver Burden and Psychological Resilience, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy (time frame: Baseline and 1 week after completion of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.