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

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. 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.
  2. 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.
  3. 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.
  4. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
238

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital of Medical College of Zhejiang University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Risk Assessment of Disability and Precision Intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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