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NCT Number: NCT06863727

The Beijing Longitudinal Disability Survey in Community Elderly

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?

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location status: Recruiting

Location contact

Yansu Guo, Ph.D

CONTACT

[email protected]

0086031183973736

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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."

Study contacts

Contact information is provided by the study sponsor or research team.

Yansu Guo, Ph.D

CONTACT

[email protected]

0086031183973736

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Beijing Municipal Health Commission

Registry information

Acronym: BLINDSCE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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