Clinical trial NCT05990114: Evaluation of the Structured Caregiver Support Program (SCSP) in Terms of Various Parameters
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
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: psychosocial intervention
Alzheimer's disease
caregivers
care burden
psychological well-being
psychological resilience
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Zarit Burden Interview
timeFrame: change from baseline to the end of the 8th week
Secondary outcomes:
measure: Psychological Well-Being Scale
timeFrame: change from baseline to the end of the 8th week
measure: Brief Resilience Scale
timeFrame: change from baseline to the end of the 8th week
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
state: Konyaaltı
Study officials:
affiliation: Ankara University
name: Hande Kirisik, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: