- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05990114
Evaluation of the Structured Caregiver Support Program (SCSP) in Terms of Various Parameters (SCSP)
Evaluation of the Effect of Structured Caregiver Support Program on the Levels of Care Burden, Psychological Well-Being and Psychological Resilience of Informal Caregivers of Alzheimer's Patients
The aim of this clinical study is to examine the effect of an intervention program developed for informal caregivers of Alzheimer's patients on caregivers' burden of care, psychological well-being and psychological resilience.The main questions it aims to answer are:
- What is the effect of the Structured Caregiver Support Program (SCSP) on caregivers burden?
- What is the effect of the SCSP on psychological well-being?
- What is the effect of the SCSP on psychological resilience?
Participants (intervention group) will attend at least 6 sessions of an 8-session SCSP.
Researchers will compare with the control group to see if the training provided is effective.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
People around the world are now living longer. The number of elderly people in need of care is increasing, especially among the population aged 80 and over, which is defined as advanced old age. Elderly care in Turkey is largely informal by family members. A significant proportion of caregivers suffer from the burden of care. Alzheimer's disease (AD) is a neurodegenerative and progressive disease that causes need for care in advanced age. Caregivers of people with AD report more stress, burden and depression than caregivers of other patients, especially in cases where neuropsychiatric symptoms are evident. Psychological well-being and psychological resilience of caregivers are also negatively affected by the care process. Therefore, caregivers need psychological and social support. The aim of this study is to evaluate the effect of the Structured Caregiver Support Program, which will be created to support caregivers psychologically and socially, on the caregiving burden, psychological well-being and psychological resilience levels of informal caregivers caring for Alzheimer's patients.
Mixed design consisting of quantitative and qualitative research methods will be used in the research.The quantitative dimension of the research will be carried out as a randomized controlled experimental study and a pre-test and post-test order will be used.In this context, an intervention program was created to examine the effect of the Structured Caregiver Support Program on caregivers' burden of caregiving, psychological well-being and psychological resilience.There will be two different groups in the study, namely the intervention group and the control group. The trial is designed as a group intervention. Therefore, all 25 caregivers in the intervention group will attend the sessions at the same time. Participants who volunteer to participate in the study will be randomly assigned to the intervention and control groups.SCSP intervention will be applied to the intervention group and no intervention will be applied to the control group.Pre-test and post-test will be applied to both the intervention and control groups before and after the intervention program.
The universe of the research consists of caregivers of patients with Alzheimer's diagnosis followed up in the Alzheimer's Social Life Center of a municipality in Ankara between September and November 2023.The sample of the study consists of caregivers who meet the criteria for inclusion in the sample of patients with Alzheimer's diagnosis followed in the Alzheimer's Social Life Center of a municipality in Ankara between September and November 2023.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Konyaaltı
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Antalya, Konyaaltı, Turkey, 07070
- Akdeniz University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Providing informal care to an individual with mild or moderate Alzheimer's disease
- Being a primary caregiver
- Having been caring for the patient for at least 6 months
- Providing care to the patient for at least 6 hours a day
- The caregiver is 18 years or older
- Residency of the caregiver in the province of Ankara
- Willingness and volunteering to participate in the research
Exclusion Criteria:
- Hearing and understanding difficulties
- Having a psychiatric disorder
- Receiving any therapy services
- Caregivers who did not attend two or more of the eight interviews were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: intervention group
The structured caregiver support program is a psychosocial training program developed to improve caregivers' burden of care, psychological well-being and resilience.This training program will be applied to the intervention group.
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It consists of 8 sessions in total.
It is planned as once a week and 45 minutes.
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No Intervention: control group
No intervention will be applied to the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Zarit Burden Interview
Time Frame: change from baseline to the end of the 8th week
|
This scale, which was developed by Zarit, Reever and Bach-Peterson in 1980, is used to measure the stress of caregivers.A minimum of 0 and a maximum of 88 points can be obtained from the scale.
A high score on the scale indicates a high level of distress.
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change from baseline to the end of the 8th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Well-Being Scale
Time Frame: change from baseline to the end of the 8th week
|
The 8-item Psychological Well-Being Scale, developed by Diener et al. in 2009, includes important elements of human functioning such as positive relationships, feelings of efficacy, and having a meaningful and purposeful life, and evaluates the individual's psychological well-being.A minimum of 8 and a maximum of 56 points can be obtained from the scale.
A high score indicates that the person has many psychological resources and strengths.
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change from baseline to the end of the 8th week
|
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Brief Resilience Scale
Time Frame: change from baseline to the end of the 8th week
|
It is a 6-item self-report scale developed by Smith et al. in 2008.
After the reverse coded items in the scale were translated, high scores indicate high psychological resilience.
|
change from baseline to the end of the 8th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hande Kirisik, Lecturer, Ankara 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
- KAEK-28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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