CClinicalTrials.gg
CompletedNCT06167889Updated Dec 13, 2023

A Study of Gender-specific Impact Factors on Elderly Disability and Cognitive Impairment

An observational study in Aging, sponsored by Fang Tang. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by Fang Tang · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
23,640
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Aging

Keywords

  • Elderly
  • Disability
  • Cognitive impairment
  • Gender-specific
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,099 are open to participants now.

This study's enrollment of 23,640 is above the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Fang Tang is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The elderly aged 65 and above in the China Longitudinal Healthy Longevity Survey (CLHLS) database and the elderly with health care neurology visits recorded in Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform

Inclusion criteria

1.The elderly aged 65 and above.

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
23,640 participants (actual)
Patient registry
No

Groups and cohorts

  • Retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform

    A retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform is conducted to collect data and to explore the gender differences and influencing factors of disability and cognitive impairment among the elderly.

  • Retrospective cohort from CLHLS

    The data from the China Longitudinal Healthy Longevity Survey (CLHLS) was used to further validate the results.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2002-2023

  2. 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.

    Time frame: 2002-2023

07

Study locations

1 site
  • The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
    Jinan, Shandong 250014, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06167889
Lead sponsor
Fang Tang
Responsible party
Fang Tang (Doctor, Qianfoshan Hospital) — Sponsor-investigator
First posted
Dec 13, 2023
Start date
Jan 1, 2009
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023
Last update
Dec 13, 2023

Study contacts

Fang Tang, Doctor
principal investigator · The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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