Effects of Comprehensive Community Support Programs on Cognitive Function and Quality of Life in Older Adults

May 20, 2026 updated by: Prof. Lutfu Hanoglu, MD, Istanbul Medipol University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Bagcılar
      • Istanbul, Bagcılar, Turkey (Türkiye)
        • Recruiting
        • Vefahane Life Center, Bagcilar Municipality
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Participation Group
Older adults actively participating in multidomain community-based activities and supportive services provided at the Vefahane Life Center.
Behavioral: Multidomain Community Support Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vefahane Bağcılar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMU_Vefa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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