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临床试验/NCT05731167
NCT05731167招募中不适用

Validation and Application of a Multi-dimentional Frailty Assessment Tool-Cohort Intervention and Follow up

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2023年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
216
试验地点
1
主要终点
Hospitalization

研究概览

简要总结

We aim to (1) use a multifaceted, frailty assessment model. (2) use randomized controlled trials to deal with and intervene with cross-field, multi-faceted and intelligent remote management strategies for the elderly with different degrees of frailty, to further observe functional changes and analyze the probability of adverse prognosis such as falls, hospitalization, and death in the future

详细描述

Background: Frailty is a common problem among the elderly, and it is closely related to their own age, chronic diseases, physical function, and nutritional status. The higher the incidence, the higher the age. Frailty is also associated with many adverse outcomes, such as falls, disability and even mortality. At present, there is no ideal treatment for frailty. It is best to start with prevention and take precautions against various frailty factors in advance. There are two types of frailty assessments in this study. The Clinical Frailty Scale is a single observational assessment method, which can roughly know your frailty degree. Frailty indicators are further combined with questionnaires and instrumental measurements, which can be subdivided to explore different weaknesses such as subjective frailty, objective frailty, sarcopenia, osteoporosis risk, and fall risk for analysis.

Objects: Elderly people in the community (over 65 years old) who seek medical treatment in the Geriatrics Department of National Taiwan University Hospital, and who are willing to accept the frailty index test are eligible for admission. We expect to enroll about 216 cases from 2023.2.1 to 2024.12.31 with intervene and follow up for 1 year.

Method:. All the elders were given questionnaires and instruments to measure various frailty indicators, such as walking speed, standing up and walking test, muscle mass index, grip strength, 5 times of sitting and standing speed, and various physiological indicators such as blood oxygen, body fat, etc. The subjects will be randomly assigned to the intervention group or the control group. The control group will receive routine outpatient care. The intervention group will receive multi-faceted frailty prevention and treatment programs such as physical exercises, nutritional advice, cognitive training, and drug education. After that, the prognosis will be tracked by telephone every 3 months, and the self-evaluation questionnaire and the measurement of frailty indicators will be carried out at the 6th and 12th months. In order to observe the changes in the prognosis and frailty indicators of the two groups in one year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • adults aged greater than 65 years in outpatient department

排除标准

  • with dementia
  • with active cancer and those unable to operate or follow measuring instructions.
  • Individuals with pacemakers or metal implants were excluded because those devices may interfere with measurement of body composition using the bioelectrical impedance analysis (BIA) technique

结局指标

主要结局

Hospitalization

时间窗: 1 year

Hospitalization times will be evaluated by phone contact to subjects.

Fall

时间窗: 1 year

fall rate will be evaluated by phone contact to subjects.

Emergency room visits

时间窗: 1 year

Emergency room visits will be evaluated by phone contact to subjects.

次要结局

  • Skeletal muscle index(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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