The Beijing Longitudinal Disability Survey in Community Elderly

Recruiting

• Conditions: Ageing; Disability; Cognitive Impairment; Frailty; Intrinsic Capacity

• Registration Number: NCT06863727
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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?

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 Timeline

• Study Start: 2023-08-07
• Study First Submitted: 2025-02-16
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Primary Completion: 2028-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1962

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability from the individual's perspective	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).
Disability from the medical's perspective	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 Outcome Measures

Name	Time	Method
Subjective cognitive decline	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.
Cognitive impairment	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.
Hospitalization	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.
Death	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.
Appendicular skeletal muscle mass	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.
Intrinsic capacity	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.
Frailty	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.
Muscle strength	An average of 1 to 2 years	Muscle strength is assessed by the grip strength. The higher the value, the better the outcome.
Physical performance	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.
Sarcopenia	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."

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China