- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06863727
The Beijing Longitudinal Disability Survey in Community Elderly (BLINDSCE)
March 3, 2025 updated by: Xuanwu Hospital, Beijing
The goal of this observational study is to establish the prospective cohort of the Beijing Longitudinal Disability Survey in Community Elderly (BLINDSCE) to explore the high-risk factors and preventive interventions for disability and cognitive impairment among community-dwelling adults aged 65 years and over. The main question it aims to answer is:
- What are the high-risk factors able to predict the incidence and advance of disability and cognitive impairment in community-dwelling adults aged 65 years and over?
- What are the categories of function and cognitive performance trajectory in community-dwelling adults aged 65 years and over?
Study Overview
Status
Recruiting
Detailed Description
BLINDSCE is a community-based prospective cohort study that includes individuals aged 65 and over from urban and rural areas in Beijing.
Participants will provide detailed demographic information and undergo multifactorial questionnaires, disability measurements, cognitive assessments, other disability-related outcomes, and clinical biochemical measures.
The study has started recruitment and enrollment in 2023 and will follow-up once every 1-2 year.
This work consists of three steps as follows.
First, by collecting baseline and follow-up data of participants, we plan to establish a community-dwelling elderly database in Beijing.
Second, high-risk factors can be pre-screening based on this cross-sectional analysis.
Third, longitudinal data was used to develop the prediction model and trajectory analysis for disability and cognitive impairment.
Study Type
Observational
Enrollment (Estimated)
1962
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yansu Guo, Ph.D
- Phone Number: 0086031183973736
- Email: gys188@163.com
Study Locations
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-
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Beijing, China, 100053
- Recruiting
- Xuanwu Hospital, Capital Medical University
-
Contact:
- Yansu Guo, Ph.D
- Phone Number: 0086031183973736
- Email: gys188@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Community residents aged 65 years or older in Beijing
Description
Inclusion Criteria:
- Community-dwelling adults aged 65 years or older who reside in Beijing.
- Participants who sign an institutionally approved informed consent.
Exclusion Criteria:
- Participants with severe mental disorders and serious medical conditions preventing study investigation
- Participants undergoing long-term professional treatment for physical function and cognitive functioning, such as hospitalization or rehabilitation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability from the individual's perspective
Time Frame: An average of 1 to 2 years
|
Disability is assessed using the 12-item World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0).
The WHODAS 2.0 is a patient-reported disability measure, comprising six life domains involving cognition, mobility, self-care, interpersonal relationships, life activities, and participation.
The total score of 12-item WHODAS 2.0 categorizes disability from no disability (score 0) to complete disability (score 48).
|
An average of 1 to 2 years
|
|
Disability from the medical's perspective
Time Frame: An average of 1 to 2 years
|
Disability is assessed using the basic activities of daily living (BADL) scale, the Katz Index scale.
The minimum value is 0 , and the maximum value is 6.
The higher the score, the better the outcome.
|
An average of 1 to 2 years
|
|
Disability from the medical's perspective
Time Frame: An average of 1 to 2 years
|
Disability is assessed using the instrumental activities of daily living (IADL) scale, the Lawton and Brody IADL scale.
The minimum value is 0, and the maximum value is 8.
The higher the score, the better the outcome.
|
An average of 1 to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive impairment
Time Frame: An average of 1 to 2 years
|
The cognitive impairment is assessed by the Mini-Mental State Examination (MMSE).
The minimum value is 0, and the maximum value is 30.
The higher the score, the better the outcome.
|
An average of 1 to 2 years
|
|
Cognitive impairment
Time Frame: An average of 1 to 2 years
|
The cognitive impairment is assessed by the Montreal Cognitive Assessment-Basic (MoCA-B).
The minimum value is 0, and the maximum value is 30.
The higher the score, the better the outcome.
|
An average of 1 to 2 years
|
|
Subjective cognitive decline
Time Frame: An average of 1 to 2 years
|
Subjective cognitive decline is assessed by the subjective cognitive decline questionnaire-9 items (SCD9).
The minimum value of SCD9 is 0, and the maximum value is 9, the higher the score, the worse the outcome.
|
An average of 1 to 2 years
|
|
Intrinsic capacity
Time Frame: An average of 1 to 2 years
|
Intrinsic capacity is the composite of physical and mental abilities that an individual can draw upon.
It comprises locomotor, sensory (hearing and vision), vitality, psychological, and cognition domains.
The intrinsic capacity composite score is used to assess intrinsic capacity.
The intrinsic capacity composite score ranges from 0 to 100, and the higher the score, the better the outcome.
|
An average of 1 to 2 years
|
|
Intrinsic capacity
Time Frame: An average of 1 to 2 years
|
Intrinsic capacity is assessed by the integrated care for older people (ICOPE) scale.
The minimum value of the ICOPE score is 0, and the maximum value is 5, the higher the score, the better the outcome.
|
An average of 1 to 2 years
|
|
Frailty
Time Frame: An average of 1 to 2 years
|
Frailty is assessed using the Fried frailty phenotype (FFP) scale.
The minimum value is 0, and the maximum value is 5.
The higher the score, the worse the outcome.
|
An average of 1 to 2 years
|
|
Hospitalization
Time Frame: An average of 1 to 2 years
|
Hospitalized times, duration, diagnosis, surgery, bedridden status, assisted ventilation treatment, catheter treatment are collected by questionnaire and supplemented through a review of electronic medical records.
|
An average of 1 to 2 years
|
|
Death
Time Frame: An average of 1 to 2 years
|
The date and cause of death are collected from the participant's family members/healthcare providers and supplemented through a review of electronic medical records.
|
An average of 1 to 2 years
|
|
Appendicular skeletal muscle mass
Time Frame: An average of 1 to 2 years
|
Appendicular skeletal muscle mass (ASM) is estimated using a physical measurement formula.
Weight in kilograms, height in centimeters, gender(male or female), and age in years are combined to report ASM through the formula: ASM = 0.193*weight(kg) + 0.107*height(cm) - 4.157 * gender - 0.037*age(year) - 2.631.
The higher the value, the better the outcome.
|
An average of 1 to 2 years
|
|
Muscle strength
Time Frame: An average of 1 to 2 years
|
Muscle strength is assessed by the grip strength.
The higher the value, the better the outcome.
|
An average of 1 to 2 years
|
|
Physical performance
Time Frame: An average of 1 to 2 years
|
Physical performance is assessed by the Short Physical Performance Battery (SPPB) test.
The minimum score is 0, and the maximum score is 12.
The higher the score, the better the outcome.
|
An average of 1 to 2 years
|
|
Sarcopenia
Time Frame: An average of 1 to 2 years
|
Sarcopenia is screened by the SARC-F scale.
The minimum value is 0, and the maximum value is 10.
The higher the score, the worse the outcome.
|
An average of 1 to 2 years
|
|
Sarcopenia
Time Frame: An average of 1 to 2 years
|
Sarcopenia is assessed based on the criteria recommended by the Asian Working Group for Sarcopenia (AWGS) 2019 consensus, including muscle strength, plus appendicular skeletal muscle mass (ASM), and/or physical performance.
AWGS 2019 contends that diagnosing sarcopenia requires both low muscle strength and muscle mass, and defines persons with low muscle mass, low muscle strength, and low physical performance as having "severe sarcopenia."
|
An average of 1 to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yansu Guo, Ph.D, Beijing Geriatric Healthcare and Disease Prevention Center, Xuanwu Hospital, Capital Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2023
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
July 31, 2028
Study Registration Dates
First Submitted
February 16, 2025
First Submitted That Met QC Criteria
March 3, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 3, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- No.[2023]129
- 2024-2G-20112 (Other Grant/Funding Number: Capital's Funds for Health Improvement and Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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