Smart Analysis and Decision-Making for Emerging Infectious Diseases

NCT07678619 | Enrolling By Invitation

• 1 other identifier: PKUINF-2026
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief Summary

Emerging infectious diseases, such as COVID-19, mpox, and dengue fever, are characterized by rapid transmission, wide impact, and high uncertainty, posing ongoing threats to global public health. While China achieved significant success in COVID-19 control, the response also revealed key challenges, including fragmented information, delayed risk perception, experience-dependent assessment, and inefficiencies in complex decision-making. This study aims to establish a smart technology system covering the full chain of "risk perception-situational assessment-intelligent decision-making-comprehensive evaluation." Specific objectives include: Constructing a global disease burden database and knowledge graph for emerging infectious diseases; Developing early risk assessment models covering the full transmission spectrum (cross-species, imported, and local outbreak); Building an AI-driven collective intelligence decision-support tool for epidemic control; Developing precise intervention frameworks and comprehensive evaluation indicators for key populations (e.g., elderly, students); Integrating the above technologies into a multi-agent toolkit and evaluating its effectiveness through a cluster randomized controlled trial across 52 CDC sites in five provinces (Guangdong, Zhejiang, Hubei, Sichuan, and Shanghai). The study population includes public health professionals and managers responsible for epidemic surveillance, risk assessment, decision-making, and emergency response at the city/district/county CDC levels across the five provinces. Approximately 780 participants will be enrolled. The intervention group will use the smart toolkit alongside routine practices, while the control group will follow routine practices only. The primary outcome is response time for epidemic assessment and decision-making (hours from risk perception to decision completion). Secondary outcomes include epidemic control effectiveness, user satisfaction, and socioeconomic benefits. The intervention period is 3 months, starting around July 2026 and ending in December 2027. This study has been approved by the Peking University Biomedical Ethics Committee. The study does not involve individual patient data; all data are aggregated at the district/county level from CDC sources or publicly available data. Anonymous questionnaires do not collect any personal identifiable information.

Conditions

Emerging Infectious Diseases; COVID-19; Influenza; Mpox (Monkeypox); Dengue Fever; Chikungunya Fever; Avian Influenza

Keywords

Emerging Infectious Diseases; Cluster Randomized Controlled Trial; Artificial Intelligence; Machine Learning; Risk Assessment; Early Warning; Public Health Emergency

Outcome Measures

Primary Outcomes (1)

• Response Time for Risk Assessment Report Generation and Submission

  Response time consists of two components measured in hours: (1) Report generation time - time from the diagnosis of the index case in a cluster outbreak to the system's automatic generation of the first risk assessment report and decision-support recommendations; and (2) Report submission time - time from report generation to its official submission. Measured via electronic questionnaire and CDC reporting logs.

  Measured at baseline (enrollment) and at the end of the 3-month intervention period

Secondary Outcomes (9)

• Consistency of Risk Assessment Results between Multi-Agent Toolkit and Expert Panel

  Assessed at the end of the 3-month intervention period

• Epidemic Control Effectiveness

  Assessed continuously throughout the 3-month intervention period and summarized at the end of the intervention

• User Experience and Satisfaction with the Smart Toolkit

  Measured at the end of the 3-month intervention period

• Healthcare Resource Consumption

  Assessed at the end of the 3-month intervention period

• Prevention and Control Resource Inputs

  Assessed at the end of the 3-month intervention period

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this arm will receive the multi-agent integrated smart toolkit, consisting of Data-Knowledge, Assessment, Decision, and Evaluation agents, in addition to routine infectious disease prevention and control practices. The toolkit is designed to assist CDC staff with epidemic risk perception, situational assessment, and emergency decision-making throughout the 3-month intervention period, alongside their routine CDC workflow.

Other: Multi-Agent Integrated Smart Toolkit for Emerging Infectious Diseases

Control Group

ACTIVE COMPARATOR

Participants in this arm will follow routine infectious disease prevention and control practices only, without access to the multi-agent integrated smart toolkit, including standard epidemic surveillance, information collection, risk assessment, and emergency response procedures currently implemented at their respective CDC, and will continue their regular workflow without any additional intervention during the 3-month study period.

Other: Routine Practices

Interventions

Multi-Agent Integrated Smart Toolkit for Emerging Infectious Diseases OTHER

The multi-agent integrated smart toolkit consists of four integrated agents: (1) Data-Knowledge Agent - for early risk perception based on historical event experience; (2) Assessment Agent - for risk assessment and situational analysis; (3) Decision Agent - for emergency decision support; and (4) Evaluation Agent - for effect simulation and comprehensive evaluation. The toolkit is designed to assist CDC staff with epidemic risk perception, situational assessment, and emergency decision-making. It is used alongside routine infectious disease prevention and control practices.

Also known as: SMART-ID Toolkit

Intervention Group

Routine Practices OTHER

Routine infectious disease prevention and control practices currently implemented at the CDC, including standard epidemic surveillance, information collection, risk assessment, and emergency response procedures.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Working at a district/county/city-level CDC in one of the five participating provinces/municipalities (Zhejiang, Guangdong, Hubei, Sichuan, or Shanghai) where at least one emerging infectious disease (COVID-19, mpox, influenza, dengue, chikungunya, or avian influenza) has occurred.
• Currently responsible for or involved in infectious disease epidemic prevention and control work, including information collection, risk perception, risk assessment, decision-making, risk management, and emergency response at the CDC.
• Willing to voluntarily participate in this study and provide written informed consent.

You may not qualify if:

• Under 18 years of age.
• Diagnosed with severe mental illness or other conditions that impede normal communication.
• Employed in the current CDC position for less than 1 year.

Sponsors & Collaborators

• Peking University: lead
• National Health Commission's Pharmaceutical and Health Technology Development Research Center: collaborator

Study Sites (1)

Jue Liu

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Communicable Diseases, Emerging; COVID-19; Influenza, Human; Mpox, Monkeypox; Dengue; Chikungunya Fever; Influenza in Birds

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Poxviridae Infections; DNA Virus Infections; Primate Diseases; Animal Diseases; Rodent Diseases; Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Alphavirus Infections; Togaviridae Infections; Bird Diseases

Study Officials

• Jue Liu, Doctor

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a multicenter, cluster-randomized, parallel-group trial. A total of 52 district/county/city-level Centers for Disease Control and Prevention (CDCs) across five provinces/municipalities (Guangdong, Zhejiang, Hubei, Sichuan, and Shanghai) are randomized in a 1:1 ratio to either the intervention group or the control group. Randomization is stratified by socioeconomic level (high, medium, low) for the four provinces and by urban functional zone (central urban vs. new/suburban districts) for Shanghai municipality. The trial follows a single-blind design with statisticians blinded to group allocation.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): July 17, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

CN (1)