HEalthy Aging Team Supported Home-care Services (HEAT-YASAM)

Depression Clinical Trial

— HEAT-YASAM  

Official title:

Does Healthy Aging Team-supported Home-care Services Pilot Program Reduce ED Visits? A Prospective before-and After-intervention Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05993572
• Other study ID #: 2023-3-24
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Dementia
• Depression
• Drug Use
• Frailty
• Malnutrition
• Old Age; Debility

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