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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06167889
Other study ID # YXLL-KY-2023(140)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2009
Est. completion date October 31, 2023

Study information

Verified date December 2023
Source Qianfoshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Elderly disability and cognitive impairment rates were different between elderly man and woman. Sex-specific risk factors and observed gender differences across the lifespan were associated with different degrees of cognitive and activity of daily living function decline between men and women. However, some of these viewpoint remains controversial. The aim of this study is to explore the gender differences and influencing factors of disability and cognitive impairment among the elderly.


Description:

With the rapid increase in the aging population in China, age-related cognitive impairment and disability has become a pressing public health concern. A number of large-scale studies in China and abroad have shown that the average life expectancy of women elderly is higher than men, but the rates of disability and cognitive impairment are higher. However, it is lack of exploration of the factors associated with the gender-specific of disability and cognitive impairment. The aim of this study is to explore the gender differences and influencing factors of disability and cognitive impairment among the elderly. A retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform is conducted to collect data. And the data from the China Longitudinal Healthy Longevity Survey (CLHLS) was used to further validate the results.


Recruitment information / eligibility

Status Completed
Enrollment 23640
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1.The elderly aged 65 and above. Exclusion Criteria: 1. Lack of diagnostic information. 2. Missing key influencing factors such as gender and age. 3. Hearing or linguistic impairment. 4. Comatose patients.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Fang Tang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disability We identified disability according to the Katz index. This Katz index includes six activities of daily life: bathing, transferring, dressing, eating, toileting, and continence. Disability was defined as needing help with at least one of the six activities of daily life. 2002-2023
Primary Cognitive impairment The main outcome was assessed by the Chinese version of the Mini-Mental State Examination (CMMSE).For participants who had never received education, an MMSE score of 17 or less was considered as cognitive impairment; for those who had less than 6 years of education, an MMSE score of 20 or less was considered as cognitive impairment; and for those who had more than 6 years of education, an MMSE score of 24 or less was considered as cognitive impairment. For each level of education, scores above the threshold were considered cognitively normal. 2002-2023
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