- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Lütfü Hanoğlu
- Telefonnummer: 905324868048
- E-mail: lhanoglu@kure.com.tr
Studiesteder
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-
Bagcılar
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Istanbul, Bagcılar, Tyrkiet (Türkiye)
- Rekruttering
- Vefahane Life Center, Bagcilar Municipality
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Kontakt:
- Lutfu Hanoglu, MD
- Telefonnummer: 905324868048
- E-mail: lhanoglu@kure.com.tr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in global cognitive performance measured by Mini Mental State Examination (MMSE)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IMU_Vefa
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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