- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07752160
Research and Application of an AI Agent-Based MBBS Course Assistant
Prior to the quasi-experiment, this study performed semi-structured interviews among Bachelor of Medicine and Bachelor of Surgery(MBBS) undergraduate students from the Belt and Road International Medical College, Zhejiang University. Based on learning science, cognitive load theory and causal inference frameworks, the interview outline focused on system usability, feedback quality, learning reasoning processes, cognitive burden and instructional optimization advice. Each 20-30 minute individual interview was audio-recorded with participants' informed consent and verbatim transcribed for standardized qualitative analysis.
The quasi-experiment recruited no fewer than 60 MBBS students. The sample size was determined by intergroup statistical power analysis to guarantee around 30 participants per group for valid intergroup comparison. All eligible students were randomly assigned into two groups with balanced demographic and academic baseline characteristics. The experimental group (n=30) received structured epidemiological learning assisted by the (Socratic Agent for Guided Epidemiology) SAGE (Artificial Intelligence)AI agent with professional Socratic cognitive guidance. The control group (n=30) adopted general large language model (LLM)-based learning without systematic thinking intervention. Participants with clinically diagnosed severe mental disorders, cognitive dysfunction or inability to finish the complete research process were excluded. A baseline epidemiological knowledge pre-test confirmed no significant academic differences between the two groups via independent samples t-test, and all participants had no prior experience of AI-assisted medical learning.
The semi-structured interviews were conducted to collect students' authentic learning experiences, interactive perceptions and cognitive characteristics during the use of SAGE agent and general LLMs, providing qualitative evidence for the iterative optimization of AI teaching tools. All interviewees completed baseline assessments and preliminary AI learning trials, ensuring qualified professional foundation and genuine interactive experience. Conducted by trained researchers, the standardized interviews centered on three core themes: system usability and feedback clarity; AI-induced changes in information extraction, hypothesis formulation and causal inference; and common learning barriers including interactive obstacles, comprehension difficulties, cognitive overload and potential AI over-reliance. Transcribed interview data were analyzed through thematic analysis to summarize typical user experience patterns. Qualitative outcomes were triangulated with quantitative experimental results to revise the SAGE teaching protocol, optimize agent prompt chains and improve the interpretation of experimental findings.
The quasi-experiment consisted of three standardized stages. In the pre-test stage, all participants signed informed consent, completed a 25-item clinical epidemiology knowledge scale, an 11-item reasoning ability test and a demographic questionnaire to establish consistent baseline levels. In the intervention stage, the experimental group received standardized training in confounder identification and causal inference construction in strict accordance with the SAGE teaching protocol. The SAGE agent improved students' advanced epidemiological reasoning ability through continuous multi-round Socratic questioning and targeted cognitive guidance. The control group received equal-duration learning in the same experimental environment, only using conventional search engines and unguided LLMs for basic information retrieval without any cognitive and thinking intervention. All participants submitted screenshots to record their accurate AI tool usage duration after completing learning tasks.
In the post-test stage, all participants finished parallel-version epidemiological knowledge assessments and unified reasoning ability tests. Validated scales were adopted to evaluate students' cognitive load, system usability, learning satisfaction and academic self-confidence. Students' final scores of the Epidemiology course were collected as supplementary indicators of long-term learning effectiveness. Upon the completion of data collection, backend AI interaction logs were summarized and strictly screened. Invalid samples with insufficient interaction rounds or incomplete responses were excluded to ensure high data quality and reliable experimental conclusions.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Yibo Wu
- Telefonnummer: 0579-89935056
- E-mail: wuyiboism@zju.edu.cn
Studiesteder
-
-
Zhejiang
-
Yiwu, Zhejiang, Kina, 322000
- Rekruttering
- Zhejiang University International School of Medicine
-
Kontakt:
- Yibo Wu
- Telefonnummer: 0579-89935056
- E-mail: wuyiboism@zju.edu.cn
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 1: The undergraduate students of the "Belt and Road Initiative" International Medical School of Zhejiang University who have officially registered for the MBBS program
- 2: Voluntary signing of the informed consent form
Exclusion Criteria:
- 1: Having severe mental illnesses (such as severe depression, bipolar disorder, acute phase of schizophrenia), serious physical diseases or cognitive impairments
- 2: Is currently participating in other studies that may affect the outcome indicators of this research
- 3: Have systematically studied or participated in research that is highly similar to this study
- 4: No experience of AI agent learning
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention group
Socratic Agent for Guided Epidemiology
|
A total of 30 participants are assigned to the experimental group receiving the SAGE teaching model, namely the Socratic Agent for Guided Epidemiology.
|
|
Aktiv komparator: Control group
General LLM
|
30 participants are allocated to the control group with teaching assistance from a general large language model (General LLM).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Epidemiology Knowledge Assessment Scale (Utrecht questionnaire on knowledge on clinical epidemiology for evidence-based practice)
Tidsramme: Before the intervention (One to seven days before starting the epidemiology course) and After the intervention(Within half a month after completing the epidemiology course)
|
The test consists of 19 multiple-choice questions and 2 calculation questions, each worth 1 point.
There are also 4 essay questions, each worth 3 points.
The total score is 33 points.
The higher the score, the better the mastery of clinical epidemiology knowledge.
|
Before the intervention (One to seven days before starting the epidemiology course) and After the intervention(Within half a month after completing the epidemiology course)
|
|
Epidemiological Reasoning Test
Tidsramme: Before the intervention (One to seven days before starting the epidemiology course ) and After the intervention(Within half a month after completing the epidemiology course)
|
This section consists of eleven questions and is designed to test students' epidemiological reasoning skills.
Scores range from 0 to 11, with higher scores indicating higher levels of epidemiological reasoning ability.
|
Before the intervention (One to seven days before starting the epidemiology course ) and After the intervention(Within half a month after completing the epidemiology course)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
System Usability Scale(SUS)
Tidsramme: Immediately after intervention(One to seven days after completing the epidemiology course)
|
It consists of 10 items and is scored using the Likert scale (1 = strongly disagree, 5 = strongly agree).
The total score is converted to a range of 0-100 to evaluate the overall usability of the system.
Additionally, based on a standardized scoring system, the SUS score is assigned letter grades, ranging from "F" (0-60 points) to "A" (91-100 points).
|
Immediately after intervention(One to seven days after completing the epidemiology course)
|
|
Needs and perceptions questionnaire (AI-powered simulation-based teaching agent)
Tidsramme: Qualitative research stage (one to five months before starting the epidemiology course
|
This questionnaire employs the 5-point Likert scale (ranging from 1 to 5), with a total score range of 18 to 90.
The higher the score, the greater the subject's acceptance of the AI-assisted teaching system, the effectiveness of teaching support, and the evaluation of its application value.
|
Qualitative research stage (one to five months before starting the epidemiology course
|
|
Student's final exam score in the Epidemiology course
Tidsramme: Immediately after intervention(One to seven days after completing the epidemiology course)
|
The score ranges from 0 to 100 points.
A score of 60 or above is considered passing.
|
Immediately after intervention(One to seven days after completing the epidemiology course)
|
|
Demographic information questionnaire
Tidsramme: Before the intervention (One to seven days before starting the epidemiology course)
|
The title of this section is used to analyze demographic data, and it mainly includes Name,Tel,Birthday,Gender,Grade,Country,GPA or credit grade,Monthly Disposable income,your father's education level,your mother's education level, Previous AI Experience.
|
Before the intervention (One to seven days before starting the epidemiology course)
|
|
Learning Satisfaction and Self-confidence Scale
Tidsramme: Immediately after intervention(One to seven days after completing the epidemiology course)
|
Participants rated each item using a Likert-type response scale indicating their level of agreement with the statements (1 = strongly disagree to 5 = strongly agree).
the total score ranges from 13 to 65.Higher scores indicated greater satisfaction with the learning experience and higher perceived self-confidence in learning.
|
Immediately after intervention(One to seven days after completing the epidemiology course)
|
|
Cognitive Load Scale
Tidsramme: After the intervention(Within half a month after completing the epidemiology course)
|
The 10 items are scored on a scale of 0 ("completely not") to 10 ("completely"), with higher scores indicating greater cognitive load.
Total score ranges from 0 to 100 points.
|
After the intervention(Within half a month after completing the epidemiology course)
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KY-2025-374
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .