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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yansu Guo, Ph.D
  • Phone Number: 0086031183973736
  • Email: gys188@163.com

Study Locations

  • China
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Municipal Health Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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