- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06923410
Clinical Intelligent Management System - Multilingual Exploration
Multilingual Exploration of the Clinical Intelligent Management System Based on a Multimodal Foundation Model
This study aims to explore the diagnostic and therapeutic performance of a multimodal foundation model-based clinical intelligent management system in simulated outpatient scenarios. Specifically, it will compare the system's AI agent with general practitioners from different linguistic and cultural backgrounds worldwide, as well as various dialect and minority language regions in China.
The study will be conducted across multiple centers in diverse regions to comprehensively evaluate the system's adaptability. Using a prospective, single-blind design, each center will recruit primary care physicians.
Standardized simulated patients across all centers will be trained based on the same set of standardized cases and then will consult with four real physicians and the AI agent, ensuring consistency.
By comparing diagnostic and treatment quality, patient satisfaction, and clinical outcomes, this study aims to explore the system's effectiveness in enhancing primary care and patient management across different regions and linguistic environments.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Beijing
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Beijing, Beijing, China, 102218
- Recruiting
- Tiantongyuan North Community Healthcare Center
-
Contact:
- Professor
- Phone Number: 010-50985761
- Email: jzh23@mails.tsinghua.edu.cn
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria for primary care physicians:
- Fluent in the local languages spoken at each center.
- With the general practice medical qualifications.
- Agree to participate in the study and sign the informed consent form.
Inclusion criteria for simulated patient volunteers:
- Age ≥ 18 years.
- Fluent in the local languages spoken at each center.
- Able to use electronic devices with intelligent systems.
- Able to accurately express symptoms and participate throughout the process.
- Agree to participate in the study and sign the informed consent form.
Exclision criteria: N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: AI Agent Doctor group
Standardized simulated patients consult with AI Agent Doctor, providing AI-generated diagnoses and treatments for health care.
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The clinical intelligent AI system is equipped with an AI agent doctor, enabling patients to conduct self-consultations and receive care anytime and anywhere without the need for a real doctor.
|
|
No Intervention: Primary care physicians groups
Standardized simulated patients consult with physicians, providing routine diagnoses and treatments as their usual standard health care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comprehensive Assessment of physician's clinical abilities
Time Frame: Immediately after the simulated consultation
|
Clinical Abilities Assessment Scales for Primary Care (range: 0 to 100 for each case; the higher scores means the better performance)
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Immediately after the simulated consultation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System's Usability
Time Frame: Immediately after the simulated consultation with AI system
|
System Usability Evaluation Scale accessed by participating simulated patients, rated on a five-point Likert scale from strongly disagree (1) to strongly agree (5).
(A higher scale value indicates higher perceived usability of the technology.)
|
Immediately after the simulated consultation with AI system
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 24694-4-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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