Clinical Intelligent Management System - Multilingual Exploration

NCT06923410 | Recruiting DMC

• 1 other identifier: 24694-4-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Care Diseases

Outcome Measures

Primary Outcomes (1)

• Comprehensive Assessment of physician's clinical abilities

  Clinical Abilities Assessment Scales for Primary Care (range: 0 to 100 for each case; the higher scores means the better performance)

  Immediately after the simulated consultation

Secondary Outcomes (1)

• System's Usability

  Immediately after the simulated consultation with AI system

Study Arms (2)

AI Agent Doctor group

ACTIVE COMPARATOR

Standardized simulated patients consult with AI Agent Doctor, providing AI-generated diagnoses and treatments for health care.

Device: AI model

Primary care physicians groups

NO INTERVENTION

Standardized simulated patients consult with physicians, providing routine diagnoses and treatments as their usual standard health care.

Interventions

AI model DEVICE

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.

AI Agent Doctor group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• Tsinghua University: lead

Study Sites (1)

Tiantongyuan North Community Healthcare Center

Beijing, Beijing Municipality, 102218, China

RECRUITING

Study Design

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

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 11, 2025
• Study Start: April 15, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)