AgeingBLINDSCENCT06863727
The Beijing Longitudinal Disability Survey in Community Elderly
An observational study of Ageing and Disability, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ageing, Disability, Cognitive Impairment
- How many people
- 1,962 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2023to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community residents aged 65 years or older in Beijing
Who may be able to join
- Community-dwelling adults aged 65 years or older who reside in Beijing.
- Participants who sign an institutionally approved informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Yansu Guo, Ph.D, 0086031183973736, gys188@163.com
About this study
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?
Read the 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.
- Conditions
- Ageing, Disability, Cognitive Impairment, Frailty, Intrinsic Capacity
- Keywords
- Ageing, Disability, Cognitive Impairment, Community, Cohort
- Medical subject headings
- Cognitive Dysfunction, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability from the individual's perspective
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).
Measured: An average of 1 to 2 years
Disability from the medical's perspective
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.
Measured: An average of 1 to 2 years
Disability from the medical's perspective
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.
Measured: An average of 1 to 2 years
Secondary outcomes (13)
Cognitive impairment
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.
Measured: An average of 1 to 2 years
Cognitive impairment
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.
Measured: An average of 1 to 2 years
Subjective cognitive decline
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.
Measured: An average of 1 to 2 years
Intrinsic capacity
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.
Measured: An average of 1 to 2 years
Intrinsic capacity
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.
Measured: An average of 1 to 2 years
Frailty
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.
Measured: An average of 1 to 2 years
Hospitalization
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.
Measured: An average of 1 to 2 years
Death
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.
Measured: An average of 1 to 2 years
Appendicular skeletal muscle mass
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.
Measured: An average of 1 to 2 years
Muscle strength
Muscle strength is assessed by the grip strength. The higher the value, the better the outcome.
Measured: An average of 1 to 2 years
Physical performance
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.
Measured: An average of 1 to 2 years
Sarcopenia
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.
Measured: An average of 1 to 2 years
Sarcopenia
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."
Measured: An average of 1 to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start7 Aug 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,962 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Responsible party
- Sponsor
- Investigators
- Yansu Guo, Ph.D, Principal investigator, Beijing Geriatric Healthcare and Disease Prevention Center, Xuanwu Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863727
- Sponsor's protocol ID
- No.[2023]129
- Other IDs
- 2024-2G-20112
- Acronym
- BLINDSCE
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cheng S, Du X, Hou C, Liu H, Lei S, Wu Y, Yue X, Guo Y. Beijing Longitudinal Disability Survey in Community Elderly (BLINDSCE): protocol for a community-based prospective longitudinal cohort study about disability prediction model. BMJ Open. 2025 May 15;15(5):e091955. doi: 10.1136/bmjopen-2024-091955.
PubMed 40379348
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beijing Longitudinal Disability Survey in Community Elderly
- ClinicalTrials.gov ID
- NCT06863727
- Acronym / sponsor ID
- BLINDSCE / No.[2023]129
- Conditions
- Ageing, Disability, Cognitive Impairment, Frailty, Intrinsic Capacity
- Keywords
- Ageing, Disability, Cognitive Impairment, Community, Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,962 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community residents aged 65 years or older in Beijing
Key inclusion criteria (2 listed)
- Community-dwelling adults aged 65 years or older who reside in Beijing.
- Participants who sign an institutionally approved informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
13 secondary outcomes
Cognitive impairment
Time frame: An average of 1 to 2 years
Cognitive impairment
Time frame: An average of 1 to 2 years
Subjective cognitive decline
Time frame: An average of 1 to 2 years
Intrinsic capacity
Time frame: An average of 1 to 2 years
Intrinsic capacity
Time frame: An average of 1 to 2 years
Frailty
Time frame: An average of 1 to 2 years
Hospitalization
Time frame: An average of 1 to 2 years
Death
Time frame: An average of 1 to 2 years
Appendicular skeletal muscle mass
Time frame: An average of 1 to 2 years
Muscle strength
Time frame: An average of 1 to 2 years
Physical performance
Time frame: An average of 1 to 2 years
Sarcopenia
Time frame: An average of 1 to 2 years
Sarcopenia
Time frame: An average of 1 to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Derived from this study: PubMed 40379348Cheng S, Du X, Hou C, Liu H, Lei S, Wu Y, Yue X, Guo Y. Beijing Longitudinal Disability Survey in Community Elderly (BLINDSCE): protocol for a community-based prospective longitudinal cohort study about disability prediction model. BMJ Open. 2025 May 15;15(5):e091955. doi: 10.1136/bmjopen-2024-091955.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yansu Guo, Ph.D principal investigator
Beijing Geriatric Healthcare and Disease Prevention Center, Xuanwu Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ageing and Disability, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yansu Guo, Ph.D (0086031183973736, gys188@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability from the individual's perspective (time frame: An average of 1 to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06863727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.