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

Alzheimer Disease Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05990114
• Other study ID #: department of gerontology
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 2023
• Est. completion date: November 2023

Study information

• Verified date: August 2023
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. What is the effect of the Structured Caregiver Support Program (SCSP) on caregivers burden?

2. What is the effect of the SCSP on psychological well-being?

3. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• The structured caregiver support program
It consists of 8 sessions in total. It is planned as once a week and 45 minutes.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya	Konyaalti

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 week
Primary	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.	8 week
Primary	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.	8 week