HEAT-YASAM: HEalthy Aging Through YASAM

Sponsor
Gulhane Training and Research Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05993572
Collaborator
Provincial Health Services Authority (Other)
2,000
1
29.6
67.6

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Comprehensive Geriatric Assessment

Detailed Description

Individuals over the age of 80 who will participate in the YASAM project will first be informed by phone and their appointments will be made. Subsequently, a home visit will be conducted after obtaining verbal and written consent from the patients and their relatives.

The chronic diseases and medications of the patients will be questioned and controlled from the electronic data set. To determine the level of frailty and dependency, the Katz, Lawton-Brody, and Clinical Frailty scales will be filled in, respectively, by the previously trained health personnel, by interviewing their relatives. Mini-Cog, Mini Mental Status Assessment, Mini Nutrition Assessment, and Geriatric Depression (Yesavage) Assessments will be planned. According to dependency status, individuals will be re-evaluated in the 1st or 2nd month. If the patients are fully independent, control follow-up is planned in the 3rd month. Written file records will be created by obtaining the consent of the patients and their relatives at each patient visit. Each team will be responsible for the follow-up of 300 patients. 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 and whose coordination center is Atatürk city hospital. In the follow-ups, it is planned to include the whole cohort consisting of 40 thousand individuals over the age of 80, by increasing the number of teams. The short-term results of the patient's follow-up (1st, 3rd, and 6th-month results), changes in mortality, addiction, frailty level, and changes in nutrition and cognitive functions within the specified period will be evaluated as short-term results. It is aimed to record the long-term outcomes (1st and 2nd year) of the same variables.

Since the whole population will be included in the study, sample size and power analysis were not performed.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
HEalthy Aging Through YASAM: Prospective Longitudinal Study
Actual Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Short term Healthy Aging status (mortality) [1-,3-,6- month]

    Outcomes were evaluated according to the national electronic database.

  2. Short term Healthy Aging status (changes dependency ) [1-,3-,6- month]

    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)

  3. Short term Healthy Aging status (changes in frailty level) [1-,3-,6- month]

    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).

  4. Short term Healthy Aging status (changes in nutrition) [1-,3-,6- month]

    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).

  5. Short term Healthy Aging status (changes in cognitive functions) [1-,3-,6- month]

    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)

  6. Short term Healthy Aging status (changes in mood) [1-,3-,6- month]

    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)

  7. Short term Healthy Aging status (changes in mobility status) [1-,3-,6- month]

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

  8. Long term Healthy Aging status (mortality) [1- and 2- year]

    Outcomes were evaluated according to the national electronic database.

  9. Long term Healthy Aging status (changes dependency ) [1- and 2- year]

    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)

  10. Long term Healthy Aging status (changes in frailty level) [1- and 2- year]

    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.)

  11. Long term Healthy Aging status (changes in nutrition) [1- and 2- year]

    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).

  12. Long term Healthy Aging status (changes in cognitive functions) [1- and 2- year]

    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).

  13. Long term Healthy Aging status (changes in mood) [1- and 2- year]

    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).

  14. Long term Healthy Aging status (changes in mobility status) [1- and 2- year]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
80 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 80 years and over older adults

  • individuals giving verbal and written consent for the YASAM project

Exclusion Criteria:
  • <80 years older adults

  • those who did not give verbal and written consent for the YASAM project

Contacts and Locations

Locations

Site City State Country Postal Code
1 Balikesir Ataturk City Hospital Balikesir None Selected Turkey 10100

Sponsors and Collaborators

  • Gulhane Training and Research Hospital
  • Provincial Health Services Authority

Investigators

  • Study Director: Bilal Katipoglu, Gulhane Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bilal Katipoglu, Associate Professor, Gulhane Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05993572
Other Study ID Numbers:
  • 2023-3-24
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2023