Alzheimer DiseaseSCSPNCT05990114
Evaluation of the Structured Caregiver Support Program (SCSP) in Terms of Various Parameters
A study testing The structured caregiver support program in people with Alzheimer Disease, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- The structured caregiver support program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2023to 22 Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- The structured caregiver support program
- Keywords
- psychosocial intervention, Alzheimer's disease, caregivers, care burden, psychological well-being, psychological resilience
- Medical subject headings
- Alzheimer Disease, Caregiver Burden, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The structured caregiver support programOther
It consists of 8 sessions in total. It is planned as once a week and 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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. Receives: Other: The structured caregiver support program |
| control group | No intervention | No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline to the end of the 8th week
Secondary outcomes (2)
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.
Measured: change from baseline to the end of the 8th week
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.
Measured: change from baseline to the end of the 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start4 Oct 2023
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Kirisik, Ankara University
- Investigators
- Hande Kirisik, Lecturer, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990114
- Sponsor's protocol ID
- KAEK-28
- Acronym
- SCSP
- Status last verified
- Mar 2025
- First submitted
- 3 Aug 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05990114
- Acronym / sponsor ID
- SCSP / KAEK-28
- Conditions
- Alzheimer Disease
- Keywords
- psychosocial intervention, Alzheimer's disease, caregivers, care burden, psychological well-being, psychological resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 14 Aug 2023 (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.
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. 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: The structured caregiver support programThe 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. |
| control group | No intervention | –No intervention will be applied to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| The structured caregiver support programIt consists of 8 sessions in total. It is planned as once a week and 45 minutes. | Other | intervention group |
Primary outcome
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.
2 secondary outcomes
Psychological Well-Being Scale
Time frame: change from baseline to the end of the 8th week
Brief Resilience Scale
Time frame: change from baseline to the end of the 8th week
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 2 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Hande Kirisik, Lecturer principal investigator
Ankara 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 The structured caregiver support program in people with Alzheimer Disease, run by Akdeniz 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 7 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 2 Apr 2025. 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?
Zarit Burden Interview (time frame: change from baseline to the end of the 8th week). 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 2 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.