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临床试验/NCT05993572
NCT05993572Enrolling By Invitation不适用

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

Gulhane Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
2,000
试验地点
1
主要终点
Short term Healthy Aging status (changes in frailty level)

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
80 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Short term Healthy Aging status (changes in frailty level)

时间窗: 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).

Short term Healthy Aging status (changes in cognitive functions)

时间窗: 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)

Short term Healthy Aging status (changes dependency )

时间窗: 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)

Short term Healthy Aging status (changes in mood)

时间窗: 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)

Long term Healthy Aging status (changes in cognitive functions)

时间窗: 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).

Long term Healthy Aging status (changes in mood)

时间窗: 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).

Short term Healthy Aging status (mortality)

时间窗: 1-,3-,6- month

Outcomes were evaluated according to the national electronic database.

Short term Healthy Aging status (changes in nutrition)

时间窗: 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).

Short term Healthy Aging status (changes in mobility status)

时间窗: 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).

Long term Healthy Aging status (changes dependency )

时间窗: 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)

Long term Healthy Aging status (changes in frailty level)

时间窗: 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.)

Long term Healthy Aging status (changes in nutrition)

时间窗: 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).

Long term Healthy Aging status (mortality)

时间窗: 1- and 2- year

Outcomes were evaluated according to the national electronic database.

Long term Healthy Aging status (changes in mobility status)

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Gulhane Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Bilal Katipoglu

Associate Professor

Gulhane Training and Research Hospital

研究点 (1)

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