NCT06167889

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23,640

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

14.8 years

First QC Date

December 4, 2023

Last Update Submit

December 11, 2023

Conditions

Keywords

ElderlyDisabilityCognitive impairmentGender-specific

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • The elderly aged 65 and above.

You may not qualify if:

  • Lack of diagnostic information.
  • Missing key influencing factors such as gender and age.
  • Hearing or linguistic impairment.
  • Comatose patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Fang Tang, Doctor

    The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 13, 2023

Study Start

January 1, 2009

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations