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临床试验/NCT06276166
NCT06276166尚未招募不适用

Study of the Joint Trajectory of Frailty and Cognitive Dysfunction Among Community-dwelling Older Adults

Zheng Li0 个研究点目标入组 934 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
934
主要终点
Cognitive function

研究概览

简要总结

To explore the heterogeneity of the development trend of frailty and cognitive function of older adults.

详细描述

According to the inclusion and exclusion criteria, the older adults will be selected from community health service centers in four districts of Beijing. Frailty and cognitive function of the older adults will be assessed for a 24-month longitudinal multi-time (baseline, 6, 12 and 24 months). The heterogeneity of the development trend of frailty and cognitive function will be explored, and the subgroups of joint development trajectory of frailty and cognitive impairment will be classified, so as to identify high-risk populations that need to be managed.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age ≥60 years.
  • •Older adults with clear consciousness, ability of simple written and verbal communication.
  • •They volunteered to participate in this study, and signed an informed consent.

排除标准

  • •A clear diagnosis of any type of dementia.
  • •There are neurological diseases that clearly lead to cognitive dysfunction, such as severe cerebrovascular disease, brain trauma, intracranial tumors, etc.
  • •They have been clearly diagnosed with mental disorders affecting cognitive function, including schizophrenia, depression, bipolar disorder, etc.

结局指标

主要结局

Cognitive function

时间窗: Baseline, 6 month, 12 month, and 24 month

The method to assess objective cognitive function is Montreal Cognitive Assessment-Beijing version for Chinese, which is a classical tool to screen for MCI, including 7 cognitive domains (visuospatial and executive function, naming, attention, language, abstraction, delayed recall, and orientation). The total score of the scale is 30, with higher scores indicating better cognitive function. The Mini-Mental State Examination (MMSE) which included 30 questions to measure the cognitive status will be also performed to assess objective cognitive function. In addition, We use the 9-items subjective cognitive decline questionnaire (SCD-Q9) to measure the symptoms of subjective cognition. The SCD-Q9 is a simple and quick screening scale to identify those who suffer from MCI from general populations. SCD-Q9 lists the 9 core items of SCD symptoms and contains 2 dimensions and 9 items.

Frailty

时间窗: Baseline, 6 month, 12 month, and 24 month

Frailty was evaluated by the Fried phenotype model, which was proposed and validated by Fried and colleagues, and is the most widely adopted model, generally regarded as the standard model for physical frailty. In Fried's model, the frailty phenotype is based on the following five components: slowness (gait speed), weakness (hand grip), weight loss, exhaustion, and low physical activity.

次要结局

未报告次要终点

研究者

发起方
Zheng Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zheng Li

Professor

Peking Union Medical College

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