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NCT Number: NCT07508813

A Digitally-Enabled System for Precision Assessment and Intervention of Disability Risk in Older Adults

1. Identify the primary risk factors for disability in older adults through multi-dimensional risk factor screening. 2. Develop a risk stratification model for disability in older adults by integrating outcome indicators and temporal characteristics, and construct an intelligent early warning model to enable automated assessment and monitoring of disability risk. 3. Establish key digital technologies for early warning and prevention of disability risk in older adults, and develop a whole-process digital intervention platform incorporating a decision support system for disability prevention management. 4. Create a digitally empowered hospital-community-household collaborative system for precise assessment and intervention of disability risk in older adults, achieving data-driven whole-process active disability management. The system will be demonstrated and evaluated in communities with diverse characteristics across urban, county, and rural settings.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Jingfen Jin, Master

CONTACT

[email protected]

+86 13757118239

About this study

  • Multidimensional Risk Factor Screening and Identification of Key Risk Factors for Disability in Older Adults: Health records from a cohort of 100,000 urban and rural older adults in Zhejiang Province between 2018 and 2022 were reviewed. Data indicators including demographics, disease characteristics, cognitive psychological assessments, and family-social factors were extracted. Disability in older adults was used as the outcome variable to preliminarily screen risk factors, forming a multidimensional indicator set for disability risk. Principal component analysis was applied to identify disability risk syndromes. The Elastic Net model was employed to further extract major risk factors, and full-cycle key risk factors for disability were determined based on five-year risk exposure characteristics.
  • Construction of a Time Series-Based Risk Stratification and Early Warning Model for Disability in Older Adults:Integrating full-cycle disability characteristics (such as disability severity, features, and time points) as primary outcome indicators. Apply weighting and clustering decisions based on key risk factors to achieve risk stratification and identification. Define key risk factor abnormalities, risk syndromes, disability risk, and actual disability occurrence as monitoring nodes, corresponding to zero-level, level-one, level-two, and level-three warning tiers respectively. By integrating time-series features, a Long Short-Term Memory (LSTM) neural network model is constructed to develop an incapacitation risk early warning system.
  • Development of Digital Diagnosis and Treatment Technologies for Early Warning and Prevention of Disability Risk and Construction of an Intervention Decision Support System:Based on evidence-based medicine, multi-scenario disability prevention requirements, and expert consensus, a big data knowledge database and technology library for disability prevention and control wiil be established. The logical framework, technical architecture, and functional design of the disability risk intervention decision support system will be systematically planned, forming a knowledge graph network related to disability. Integrating modules for elderly disability risk assessment and dynamic monitoring, an internet-based technical module for elderly disability management will be established. This covers the entire process from information collection, assessment and monitoring, to early warning decision-making and targeted interventions. The system will be deeply integrated and optimised with the 'Internet Plus Nursing' platform to construct a digitalised elderly disability risk intervention platform.
  • Application of the Precision Assessment and Intervention System for Disability Risks in the Elderly: Conducting standardized demonstration research on disability prevention and control bases using this system. Establish demonstration bases in cities, counties, and townships across Zhejiang Province to develop standardized protocols for preventing disability among the elderly through coordinated efforts between hospitals, communities, and households.Based on data-driven to optimize staffing, service processes, resource integration and technical support, we will continue to improve the overall technical implementation plan for intelligent assessment, monitoring and precise intervention of disability risk in the elderly.This will build a multi-level demonstration model for the prevention and control of elderly disability risk in cities, counties and townships in Zhejiang Province.The application effect of the elderly disability risk accurate assessment and intervention system was evaluated by indicators such as disability risk score, disability incidence, disability intervention compliance.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Community-dwelling permanent residents aged ≥65 years;
  • Able to operate a smartphone independently or with assistance from a primary caregiver;
  • Clear consciousness with basic comprehension and communication abilities;
  • Voluntarily agree to participate in the study and provide informed consent.

Exclusion criteria

  • Those who are unable to perform basic activities of daily living independently, or who have significant cognitive or communication impairments.

Treatment and study plan

Risk Assessment of Disability and Precision Intervention

Other

Implement a digital platform for elderly disability risk intervention to conduct comprehensive, multi-scenario intelligent assessments, dynamic monitoring, and targeted interventions for disability risks.

Primary outcomes

  1. SPPB(SHORT PHYSICAL PERFORMANCE BATTERY PROTOCOL)

    Time frame: At baseline, 3 months after intervention, and 6 months after intervention

    the range of score is 0-12, and the higher scores mean a better outcome.

Secondary outcomes

  1. Incidence of disability

    Time frame: 6 months after intervention

    The incidence of disability will be assessed using validated scales for Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL). Disability is defined as a new-onset, significant limitation in performing basic or complex everyday activities. The occurrence (i.e., the number of new cases) of disability will be determined at predefined study timepoints. The final outcome will be calculated as the proportion or rate of participants who develop disability during the study period, relative to the total number of participants.

  2. Disability Risk Score

    Time frame: At baseline, 3 months after intervention, and 6 months after intervention

    The Disability Risk Score is a continuous variable ranging from 0 to 1, calculated using a pre-validated prediction model. A higher score indicates a greater predicted risk of developing disability.

  3. Intervention adherence

    Time frame: 3 months after intervention, and 6 months after intervention

    Adherence to the intervention protocol (e.g., exercise, dietary tasks) will be objectively monitored and recorded via a dedicated smartphone application. Participants are required to log or "check-in" within the app upon completion of each prescribed task. Adherence rates will be calculated as the percentage of completed tasks logged, relative to the total number of tasks assigned during the study period.

Study contacts

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

Jingfen Jin, Master

CONTACT

[email protected]

+86 15888841161

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

The Construction of a Digitally-Enabled Precision Assessment and Intervention System for Disability Risk in Older Adults and a Full-Cycle, Multi-Scenario Demonstration Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

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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