Trajectory of Frailty and Cognitive Dysfunction in Older Adults

Not yet recruiting

• Conditions: Community-dwelling Older Adults; Cognitive Dysfunction; Frailty
• Interventions: Other: No intervention

• Registration Number: NCT06276166
• Lead Sponsor: Zheng Li

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.

Study Timeline

• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-18
• Study First Posted: 2024-02-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Study Start: 2024-03-15
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 934

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Older adults	No intervention	Older adults without clear diagnosis of any type of dementia, neurological diseases, and mental disorders that affecting cognitive function.

Primary Outcome Measures

Name	Time	Method
Cognitive function	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	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.