- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07508813
A Digitally-Enabled System for Precision Assessment and Intervention of Disability Risk in Older Adults
March 30, 2026 updated by: Jin Jingfen, Second Affiliated Hospital, School of Medicine, Zhejiang University
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
- Identify the primary risk factors for disability in older adults through multi-dimensional risk factor screening.
- 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.
- 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.
- 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
- 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.
Study Type
Interventional
Enrollment (Estimated)
238
Phase
- Not Applicable
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
- Name: Jingfen Jin, Master
- Phone Number: +86 15888841161
- Email: zrjzkhl@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Recruiting
- The Second Affiliated Hospital of Medical College of Zhejiang University
-
Contact:
- Jingfen Jin, Master
- Phone Number: +86 13757118239
- Email: zrjzkhl@zju.edu.cn
-
-
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
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Implement a digital platform for elderly disability risk intervention to conduct comprehensive, multi-scenario intelligent assessments, dynamic monitoring, and targeted interventions for disability risks.
|
Implement a digital platform for elderly disability risk intervention to conduct comprehensive, multi-scenario intelligent assessments, dynamic monitoring, and targeted interventions for disability risks.
|
|
No Intervention: Control group
Conduct routine community-based geriatric health management, such as health education, exercise guidance, and dietary counseling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline, 3 months after intervention, and 6 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months after intervention
|
|
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.
|
At baseline, 3 months after intervention, and 6 months after intervention
|
|
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.
|
3 months after intervention, and 6 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jingfen Jin, Master, The Second Affiliated Hospital of Medical College of Zhejiang 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)
October 31, 2025
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
September 24, 2025
First Submitted That Met QC Criteria
March 30, 2026
First Posted (Actual)
April 2, 2026
Study Record Updates
Last Update Posted (Actual)
April 2, 2026
Last Update Submitted That Met QC Criteria
March 30, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023-1268
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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