NCT05993572

Brief Summary

Depending on the YASAM project which was established to home-visit evaluate community-dwelling older adults (80 years of age and over), we aimed to determine the prevalence (prevalence) of geriatric syndromes (dependence, frailty, malnutrition, depression, dementia, comorbidity burden, polypharmacy) in these individuals and to determine possible changes in the follow-up of the patients during the 2-year follow-up period. (HEAVEN trial)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 21, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

July 21, 2023

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (14)

  • Short term Healthy Aging status (mortality)

    Outcomes were evaluated according to the national electronic database.

    1-,3-,6- month

  • Short term Healthy Aging status (changes dependency )

    Outcomes were evaluated according to the specific test Katz scales the 1 is minimum and 6 is maximum value for scale, and higher scores mean a better outcome, higher scores mean a better outcome for dependency)

    1-,3-,6- month

  • Short term Healthy Aging status (changes in frailty level)

    Outcomes were evaluated according to the specific test (Fraility via Clinical fraility scales the 1 is minimum and 9 is maximum value for scale, and higher scores mean a worse outcome).

    1-,3-,6- month

  • Short term Healthy Aging status (changes in nutrition)

    Outcomes were evaluated according to the specific test (MNA scale for nutritional status the 0 is minimum and 14 is maximum value for scale, and higher scores mean a better outcome).

    1-,3-,6- month

  • Short term Healthy Aging status (changes in cognitive functions)

    Outcomes were evaluated according to the specific test (cognitive functions with MMSE scale, the 0 is minimum and 30 is maximum value for scale, and higher scores mean a better outcome)

    1-,3-,6- month

  • Short term Healthy Aging status (changes in mood)

    Outcomes were evaluated according to the specific test (Outcomes were evaluated according to the specific test ( Yesavage for Depression status the 0 is minimum and 15 is maximum value for scale, and higher scores mean a worse outcome)

    1-,3-,6- month

  • Short term Healthy Aging status (changes in mobility status)

    Outcomes were evaluated according to the specific test (Chair stand test higher scores (\>13,5 seconds) means a worse outcome for mobility status).

    1-,3-,6- month

  • Long term Healthy Aging status (mortality)

    Outcomes were evaluated according to the national electronic database.

    1- and 2- year

  • Long term Healthy Aging status (changes dependency )

    Outcomes were evaluated according to the specific test Katz scales the 1 is minimum and 6 is maximum value for scale, and higher scores mean a better outcome, higher scores mean a better outcome for dependency)

    1- and 2- year

  • Long term Healthy Aging status (changes in frailty level)

    Outcomes were evaluated according to the specific test (Fraility via Clinical fraility scales the 1 is minimum and 9 is maximum value for scale, and higher scores mean a worse outcome.)

    1- and 2- year

  • Long term Healthy Aging status (changes in nutrition)

    Outcomes were evaluated according to the specific test (MNA scale for nutritional status the 1 is minimum and 14 is maximum value for scale, and higher scores mean a better outcome).

    1- and 2- year

  • Long term Healthy Aging status (changes in cognitive functions)

    Outcomes were evaluated according to the specific test (cognitive functions with MMSE scale, the 0 is minimum and 30 is maximum value for scale, and higher scores mean a better outcome).

    1- and 2- year

  • Long term Healthy Aging status (changes in mood)

    Outcomes were evaluated according to the specific test ( Yesavage scale for Depression status the 0 is minimum and 15 is maximum value for scale, and higher scores mean a worse outcome).

    1- and 2- year

  • Long term Healthy Aging status (changes in mobility status)

    Outcomes were evaluated according to the specific test (Outcomes were evaluated according to the specific test (Chair stand test higher scores (\>13,5 seconds) means a worse outcome for mobility status).

    1- and 2- year

Interventions

Comprehensive Geriatric Assessments include functional status, fraility comorbidity, cognition, mental health, social support, nutrition, and geriatric syndromes

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

It is planned to include a total of 6000 individuals in the first phase, which is carried out in 20 centers throughout the province of Balıkesir (rural and central area) and whose coordination center is Balikesir Atatürk City Hospital. In the follow-ups, it is planned to include the whole cohort consisting of individuals over the age of 40 thousand 80, by increasing the number of teams.

You may qualify if:

  • years and over older adults
  • individuals giving verbal and written consent for the YASAM project

You may not qualify if:

  • \<80 years older adults
  • those who did not give verbal and written consent for the YASAM project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir Ataturk City Hospital

Balıkesir, None Selected, 10100, Turkey (Türkiye)

Location

Related Publications (2)

  • Katipoglu B, Kocyigit SE, Ergun U, Kocak AO, Aydeniz O, Mert I, Keskin SK. A Community-Based Integrated Healthy Aging Program at a Tertiary Hospital (YASAM) for the Oldest Old Participants May have the Potential to Reduce Emergency Admission: Preliminary Evidence from a Pre-Post-Intervention Study. J Emerg Med. 2025 May;72:112-120. doi: 10.1016/j.jemermed.2024.12.009. Epub 2024 Dec 31.

  • Katipoglu B, Kocyigit SE. Impact of geriatric syndrome burden on healthcare services utilization and mortality among community-dwelling older adults: is it still too late to do something? Eur Geriatr Med. 2025 Jun;16(3):1055-1061. doi: 10.1007/s41999-025-01189-w. Epub 2025 Mar 22.

MeSH Terms

Conditions

FrailtyDementiaDepressionMalnutrition

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Bilal Katipoglu

    Gulhane Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2023

First Posted

August 15, 2023

Study Start

June 15, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations