NCT07449182

Brief Summary

The goal of this interventional study is to evaluate the effectiveness of a Large Language Model (LLM)-based educational AI Agent in graduate students (Masters and PhD) specializing in medicine or nursing who are enrolled in the "Machine Learning and Data Mining" course. The main questions it aims to answer are: Does the use of an educational AI Agent improve students' academic performance and practical skills in machine learning compared to traditional methods? Does the AI intervention enhance students' learning confidence, satisfaction, and cognitive engagement? Researchers will compare students currently using the AI Agent (experimental group) to a historical control group (students from the previous cohort who did not use the AI tool) to see if the AI-assisted learning model leads to significantly higher learning achievements and better educational experiences. Participants will: Utilize the Teaching Agent for real-time answers to theoretical questions, personalized study planning, and knowledge reinforcement. Engage with the Research Agent to assist with literature reviews, research design optimization, and academic writing structure. Use the Practice Innovation Agent for guidance on coding, algorithm debugging, and applying machine learning models to medical data analysis projects.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 27, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

Educational AgentMachine LearningKGRAGLarge Language Models

Outcome Measures

Primary Outcomes (1)

  • Composite Academic Performance Score

    Assessed through the final cumulative course grade (range: 0-100), which indicates the student's overall mastery of machine learning concepts and applications. The score is calculated based on three weighted components: In-class Assignments (20%): Evaluations of regular assignments submitted via the course platform. Research Progress Paper (40%): A written paper on a free-exploration topic assessing theoretical understanding and research design skills. Group Final Project Presentation (40%): Assessment of a practical project where students present solutions and results based on given medical cases and datasets. Higher scores indicate better academic performance. The experimental group's scores will be compared with the historical control group

    After the intervention (at the end of the course, approximately week 3)

Secondary Outcomes (5)

  • Objective Knowledge Acquisition Rate

    After the intervention (at the end of the course, approximately week 3)

  • Perceived Usefulness and Technology Acceptance

    After the intervention (at the end of the course, approximately week 3)

  • AI Agent Engagement: Interaction Frequency

    At the end of the course (approximately Week 3)

  • AI Agent Engagement: Temporal Patterns

    At the end of the course (approximately Week 3)

  • AI Agent Engagement: Query Themes

    At the end of the course (approximately Week 3)

Study Arms (1)

AI Agent Intervention Group

EXPERIMENTAL

Graduate students enrolled in the "Machine Learning and Data Mining" course during the 2025-2026 academic year. Participants in this group will utilize the custom-developed KGRAG-based AI Educational Agent system throughout the semester. The system includes three modules: a Teaching Agent for concept explanation, a Research Agent for academic writing support, and a Practice Innovation Agent for code generation and debugging

Other: KGRAG-based AI Educational Agent System

Interventions

The intervention involves a custom-developed AI educational system powered by Large Language Models (LLMs) and Knowledge Graph-based Retrieval-Augmented Generation (KGRAG) technology. The system comprises three specialized agents to support self-directed learning: 1. Teaching Agent: Provides real-time concept explanations, personalized study plans, and knowledge reinforcement based on the course curriculum. 2. Research Agent: Assists with literature review, research question refinement, and academic writing structure. 3. Practice Innovation Agent: Guides students through code generation, algorithm debugging, and data mining projects using Socratic tutoring methods to foster problem-solving skills. Participants have 24/7 access to this system throughout the semester.

AI Agent Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical graduate students from universities in the Guangdong-Hong Kong-Macao Greater Bay Area;
  • Graduate students who have taken the "Machine Learning and Data Mining" course;
  • Have completed the required prerequisite courses: "Medical Statistics" and "Nursing Research";
  • Capable of operating the AI Educational Agent system normally and willing to undergo relevant teaching interventions and assessments during the study period.

You may not qualify if:

  • Unwilling to use the AI education agent system, or refusing to allow the research team to collect their relevant data;
  • Students who cannot commit to the full duration of the course or have known scheduling conflicts that would prevent regular attendance;
  • Students who have previously enrolled in or audited this course in prior academic years to avoid learning effect bias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Campus of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a non-randomized study utilizing a historical control design. The current cohort of students serves as the single experimental group receiving the AI Agent intervention. Their outcomes will be compared to a historical control group (students from the previous academic year) who received standard instruction. Propensity Score Matching (PSM) will be used to control for baseline differences between the two non-concurrent cohorts.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

May 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The data will be shared one year after the results of the study'are published. The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After the publication of the study
Access Criteria
The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.

Locations