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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05993572
Other study ID # 2023-3-24
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 15, 2023
Est. completion date December 1, 2025

Study information

Verified date November 2023
Source Gulhane Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2000
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 80 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Turkey Balikesir Ataturk City Hospital Balikesir None Selected

Sponsors (2)

Lead Sponsor Collaborator
Gulhane Training and Research Hospital Provincial Health Services Authority

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Short term Healthy Aging status (mortality) Outcomes were evaluated according to the national electronic database. 1-,3-,6- month
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Long term Healthy Aging status (mortality) Outcomes were evaluated according to the national electronic database. 1- and 2- year
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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