- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07610109
Effects of Comprehensive Community Support Programs on Cognitive Function and Quality of Life in Older Adults
THE EFFECTS OF COMPREHENSIVE COMMUNITY SUPPORT PROGRAMS FOR THE ELDERLY ON COGNITIVE FUNCTIONS AND QUALITY OF LIFE: THE VEFAHANE MODEL
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lütfü Hanoğlu
- Phone Number: 905324868048
- Email: lhanoglu@kure.com.tr
Study Locations
-
-
Bagcılar
-
Istanbul, Bagcılar, Turkey (Türkiye)
- Recruiting
- Vefahane Life Center, Bagcilar Municipality
-
Contact:
- Lutfu Hanoglu, MD
- Phone Number: 905324868048
- Email: lhanoglu@kure.com.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Active Participation Group
Older adults actively participating in multidomain community-based activities and supportive services provided at the Vefahane Life Center.
|
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.
|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 3 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMU_Vefa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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