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Clinical Trials/NCT06276166
NCT06276166
Not yet recruiting
Not Applicable

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

Zheng Li0 sites934 target enrollmentMarch 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
Zheng Li
Enrollment
934
Primary Endpoint
Cognitive function
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2024
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zheng Li
Responsible Party
Sponsor Investigator
Principal Investigator

Zheng Li

Professor

Peking Union Medical College

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Cognitive function

Time Frame: 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

Time Frame: 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.

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