Clinical trial NCT05993572: HEalthy Aging Team Supported Home-care Services (HEAT-YASAM)
Official title: Does Healthy Aging Team-supported Home-care Services Pilot Program Reduce ED Visits? A Prospective before-and After-intervention Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Frailty
Dementia
Depression
Malnutrition
Old Age; Debility
Drug Use
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Provincial Health Services Authority
First posted: 2023-08-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Short term Healthy Aging status (mortality)
timeFrame: 1-,3-,6- month
measure: Short term Healthy Aging status (changes dependency )
timeFrame: 1-,3-,6- month
measure: Short term Healthy Aging status (changes in frailty level)
timeFrame: 1-,3-,6- month
measure: Short term Healthy Aging status (changes in nutrition)
timeFrame: 1-,3-,6- month
measure: Short term Healthy Aging status (changes in cognitive functions)
timeFrame: 1-,3-,6- month
measure: Short term Healthy Aging status (changes in mood)
timeFrame: 1-,3-,6- month
measure: Short term Healthy Aging status (changes in mobility status)
timeFrame: 1-,3-,6- month
measure: Long term Healthy Aging status (mortality)
timeFrame: 1- and 2- year
measure: Long term Healthy Aging status (changes dependency )
timeFrame: 1- and 2- year
measure: Long term Healthy Aging status (changes in frailty level)
timeFrame: 1- and 2- year
measure: Long term Healthy Aging status (changes in nutrition)
timeFrame: 1- and 2- year
measure: Long term Healthy Aging status (changes in cognitive functions)
timeFrame: 1- and 2- year
measure: Long term Healthy Aging status (changes in mood)
timeFrame: 1- and 2- year
measure: Long term Healthy Aging status (changes in mobility status)
timeFrame: 1- and 2- year
Secondary outcomes:
Other outcomes:
Locations:
city: Balikesir
country: Turkey
facility: Balikesir Ataturk City Hospital
state: None Selected
Study officials:
affiliation: Gulhane Training and Research Hospital
name: Bilal Katipoglu
role: STUDY_DIRECTOR
References: