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Evaluation of the Structured Caregiver Support Program (SCSP) in Terms of Various Parameters (SCSP)

Primary Purpose

Alzheimer Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The structured caregiver support program
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer Disease focused on measuring psychosocial intervention, Alzheimer's disease, caregivers, care burden, psychological well-being, psychological resilience

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Providing informal care to an individual with Alzheimer's disease Being a primary caregiver 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.

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

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.

No intervention will be applied to the control group.

Outcomes

Primary Outcome Measures

Zarit Burden Interview
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.
Psychological Well-Being Scale
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.
Brief Resilience Scale
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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
August 10, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05990114
Brief Title
Evaluation of the Structured Caregiver Support Program (SCSP) in Terms of Various Parameters
Acronym
SCSP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.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 December 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 December 2023.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
psychosocial intervention, Alzheimer's disease, caregivers, care burden, psychological well-being, psychological resilience

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention will be applied to the control group.
Intervention Type
Other
Intervention Name(s)
The structured caregiver support program
Intervention Description
It consists of 8 sessions in total. It is planned as once a week and 45 minutes.
Primary Outcome Measure Information:
Title
Zarit Burden Interview
Description
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.
Time Frame
8 week
Title
Psychological Well-Being Scale
Description
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.
Time Frame
8 week
Title
Brief Resilience Scale
Description
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.
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Providing informal care to an individual with Alzheimer's disease Being a primary caregiver 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hande Kirisik, Lecturer
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akdeniz University
City
Antalya
State/Province
Konyaaltı
ZIP/Postal Code
07070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of the Structured Caregiver Support Program (SCSP) in Terms of Various Parameters

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