Cognitive DeclineNCT07610109
Effects of Comprehensive Community Support Programs on Cognitive Function and Quality of Life in Older Adults
An observational study of Cognitive Decline and Aging, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to investigate the effects of a multidomain community-based support program on cognitive function and quality of life in older adults attending the Vefahane Life Center in Istanbul, Türkiye. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Decline, Aging, Quality of Life
- What is being tested?
- Multidomain Community Support Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Adult, Older adult
Study population: Community-dwelling older adults aged 60 years and above registered at the Vefahane Life Center in Bağcılar, Istanbul, Türkiye. Participants include individuals actively participating in multidomain community-based activities and age-compatible individuals registered at the center but not actively participating during the study period.
Who may be able to join
- Elderly individuals aged 60 and over who attend or will attend Vefahane Life Center
- Able to cooperate,
- Individuals who speak Turkish
- Individuals who are literate
Who cannot join
- Individuals previously diagnosed with dementia,
- Individuals with neurological and psychiatric diagnoses that affect cognitive skills,
- Individuals receiving occupational therapy interventions aimed at improving cognitive skills within the center,
- Individuals with illnesses that prevent participation in the activity program (cancer, cardiovascular instability, etc.),
- Individuals with severe visual and hearing loss that hinders communication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Vefahane Life Center, Bagcilar Municipality
Istanbul, Bagcılar
Lutfu Hanoglu, MD, 905324868048, lhanoglu@kure.com.tr
About this study
Official title: THE EFFECTS OF COMPREHENSIVE COMMUNITY SUPPORT PROGRAMS FOR THE ELDERLY ON COGNITIVE FUNCTIONS AND QUALITY OF LIFE: THE VEFAHANE MODEL
This prospective observational study aims to investigate the effects of a multidomain community-based support program on cognitive function and quality of life in older adults attending the Vefahane Life Center in Istanbul, Türkiye. The study will compare elderly individuals actively participating in community-based social, cognitive, physical, and supportive activities with individuals registered at the center but not actively participating during the study period. Participants will undergo neuropsychological and psychosocial assessments at baseline and after 3 months. The primary outcome is change in global cognitive performance measured by the Mini Mental State Examination (MMSE). Secondary outcomes include memory, executive functions, depression, neuropsychiatric symptoms, and quality of life measures.
Read the detailed description
Dementia is a growing global public health concern associated with aging populations worldwide. Recent evidence suggests that multidomain lifestyle interventions targeting modifiable risk factors may help preserve cognitive function and reduce dementia risk in older adults. Community-based support programs that combine cognitive, physical, social, and supportive activities may provide sustainable and culturally adaptable approaches for healthy aging.
This prospective non-interventional observational study aims to evaluate the effects of the Vefahane Life Center multidomain support model on cognitive functions and quality of life in older adults aged 60 years and above. The study will be conducted in elderly individuals registered at the Vefahane Life Center in Bağcılar, Istanbul.
Participants actively attending center-based activities will constitute the intervention/exposure group, while individuals registered at the center but not actively participating during the study period will serve as controls. Assessments will be performed at baseline and after 3 months.
The multidomain program includes social, cognitive, physical, cultural, artistic, educational, and supportive services tailored to individual preferences. Available activities include handicrafts, music, painting, physical exercise, cognitive games, language courses, hobby workshops, and psychosocial support services.
Cognitive and psychosocial outcomes will be evaluated using standardized instruments including the Mini Mental State Examination (MMSE), Subjective Memory Complaints Questionnaire (SMCQ), Trail Making Test (A+B), Verbal Memory Processes Test, Clock Drawing Test, Boston Naming Test, Neuropsychiatric Inventory (NPI), Quality of Life in Alzheimer's Disease Scale (QOL-AD), Geriatric Depression Scale (GDS), Clinical Dementia Rating Scale (CDR), and CAIDE dementia risk assessment.
The primary objective of the study is to investigate changes in global cognitive performance. Secondary objectives include evaluation of memory, executive functions, depressive symptoms, neuropsychiatric symptoms, and quality of life outcomes associated with participation in the multidomain community support program.
The study is considered minimal risk because it involves non-invasive assessments and routine community-based activities.
- Conditions
- Cognitive Decline, Aging, Quality of Life
- Being tested
- Multidomain Community Support Program
- Keywords
- older adults, aging, cognitive rehabilitation, cognitive function, community-based intervention, social wellbeing, social participation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain Community Support ProgramBehavioural
Participants in the exposure group will attend multidomain community-based activities and supportive services provided at the Vefahane Life Center according to their individual preferences. Available activities include cognitive, social, physical, cultural, artistic, educational, and supportive programs such as handicrafts, music, painting, physical exercise, cognitive games, language courses, hobby workshops, psychosocial support, occupational therapy, and counseling services. Participation frequency and attendance will be prospectively recorded throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Active Participation Group | Older adults actively participating in multidomain community-based activities and supportive services provided at the Vefahane Life Center. Receives: Behavioral: Multidomain Community Support Program | |
| Non-Participating Control Group | Older adults registered at the Vefahane Life Center but not actively participating in the available activities during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cognitive performance measured by Mini Mental State Examination (MMSE)
The primary outcome is the change in MMSE score between baseline and 3-month follow-up assessments in older adults participating in the multidomain community support program compared with controls.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start20 May 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vefahane Bağcılar
- Responsible party
- Principal investigator, Prof. Lutfu Hanoglu, MD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610109
- Sponsor's protocol ID
- IMU_Vefa
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF COMPREHENSIVE COMMUNITY SUPPORT PROGRAMS FOR THE ELDERLY ON COGNITIVE FUNCTIONS AND QUALITY OF LIFE: THE VEFAHANE MODEL
- ClinicalTrials.gov ID
- NCT07610109
- Acronym / sponsor ID
- IMU_Vefa
- Conditions
- Cognitive Decline, Aging, Quality of Life
- Keywords
- older adults, aging, cognitive rehabilitation, cognitive function, community-based intervention, social wellbeing, social participation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Vefahane Bağcılar
- Study start
- 20 May 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 May 2026 (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.
This prospective observational study aims to investigate the effects of a multidomain community-based support program on cognitive function and quality of life in older adults attending the Vefahane Life Center in Istanbul, Türkiye. The study will compare elderly individuals actively participating in community-based social, cognitive, physical, and supportive activities with individuals registered at the center but not actively participating during the study period. Participants will undergo neuropsychological and psychosocial assessments at baseline and after 3 months. The primary outcome is change in global cognitive performance measured by the Mini Mental State Examination (MMSE). Secondary outcomes include memory, executive functions, depression, neuropsychiatric symptoms, and quality of life measures.
Detailed description
Dementia is a growing global public health concern associated with aging populations worldwide. Recent evidence suggests that multidomain lifestyle interventions targeting modifiable risk factors may help preserve cognitive function and reduce dementia risk in older adults. Community-based support programs that combine cognitive, physical, social, and supportive activities may provide sustainable and culturally adaptable approaches for healthy aging.
This prospective non-interventional observational study aims to evaluate the effects of the Vefahane Life Center multidomain support model on cognitive functions and quality of life in older adults aged 60 years and above. The study will be conducted in elderly individuals registered at the Vefahane Life Center in Bağcılar, Istanbul.
Participants actively attending center-based activities will constitute the intervention/exposure group, while individuals registered at the center but not actively participating during the study period will serve as controls. Assessments will be performed at baseline and after 3 months.
The multidomain program includes social, cognitive, physical, cultural, artistic, educational, and supportive services tailored to individual preferences. Available activities include handicrafts, music, painting, physical exercise, cognitive games, language courses, hobby workshops, and psychosocial support services.
Cognitive and psychosocial outcomes will be evaluated using standardized instruments including the Mini Mental State Examination (MMSE), Subjective Memory Complaints Questionnaire (SMCQ), Trail Making Test (A+B), Verbal Memory Processes Test, Clock Drawing Test, Boston Naming Test, Neuropsychiatric Inventory (NPI), Quality of Life in Alzheimer's Disease Scale (QOL-AD), Geriatric Depression Scale (GDS), Clinical Dementia Rating Scale (CDR), and CAIDE dementia risk assessment.
The primary objective of the study is to investigate changes in global cognitive performance. Secondary objectives include evaluation of memory, executive functions, depressive symptoms, neuropsychiatric symptoms, and quality of life outcomes associated with participation in the multidomain community support program.
The study is considered minimal risk because it involves non-invasive assessments and routine community-based activities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Participation Group | – | Behavioral: Multidomain Community Support ProgramOlder adults actively participating in multidomain community-based activities and supportive services provided at the Vefahane Life Center. |
| Non-Participating Control Group | – | –Older adults registered at the Vefahane Life Center but not actively participating in the available activities during the study period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling older adults aged 60 years and above registered at the Vefahane Life Center in Bağcılar, Istanbul, Türkiye. Participants include individuals actively participating in multidomain community-based activities and age-compatible individuals registered at the center but not actively participating during the study period.
Key inclusion criteria (4 listed)
- Elderly individuals aged 60 and over who attend or will attend Vefahane Life Center
- Able to cooperate,
- Individuals who speak Turkish
- Individuals who are literate
Key exclusion criteria (5 listed)
- Individuals previously diagnosed with dementia,
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 |
|---|---|---|
| Multidomain Community Support ProgramParticipants in the exposure group will attend multidomain community-based activities and supportive services provided at the Vefahane Life Center according to their individual preferences. Available activities include cognitive, social, physical, cultural, artistic, educational, and supportive programs such as handicrafts, music, painting, physical exercise, cognitive games, language courses, hobby workshops, psychosocial support, occupational therapy, and counseling services. Participation frequency and attendance will be prospectively recorded throughout the study period. | Behavioural | Active Participation Group |
Primary outcome
Change in global cognitive performance measured by Mini Mental State Examination (MMSE)
Time frame: Baseline and 3 months
The primary outcome is the change in MMSE score between baseline and 3-month follow-up assessments in older adults participating in the multidomain community support program compared with controls.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline and Aging, run by Istanbul Medipol University Hospital 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lütfü Hanoğlu (905324868048, lhanoglu@kure.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognitive performance measured by Mini Mental State Examination (MMSE) (time frame: Baseline and 3 months). 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 27 May 2026.