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History-taking TrainingSPAR-HNCT06766383

Simulated Patient and AI-based Roleplay for History-taking

A study testing GPT-simulated patients and traditional role-playing in people with History-taking Training and GPT, run by zhen wang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to evaluate whether AI-based simulated patient training can improve clinical reasoning and history-taking skills in medical students. The main questions it aims to answer is: Does GPT-based simulated patient training improve medical students' history-taking skills compared to… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
History-taking Training, GPT, Medical Education
What is being tested?
GPT-simulated patients and traditional role-playing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
7 Oct 2024to 15 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Students enrolled in a medical or health-related professional program.
  • Clinical coursework completion:
  • Students who have completed basic clinical coursework, including foundational topics in patient communication and clinical reasoning.
  • Age group:
  • Participants aged 18-30 years to reflect typical medical student demographics.
  • Language proficiency:
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  • Adequate proficiency in the language used for the study (e.g., English) to effectively interact with the AI-simulated patient and understand feedback.
  • Willingness and availability:
  • Students who provide informed consent and are willing to participate in all required study activities, including training sessions and assessments.
  • Access to technology:
  • Ability to access and use the necessary technology, such as a computer and internet connection, to complete the simulated patient interactions.
  • -

Who cannot join

  • Students not enrolled in medical or related health professions programs. Students in early years of study who have not completed basic clinical coursework.
  • Technical limitations:
  • Inability to access or use the required technology (e.g., computer or online platforms).
  • Time constraints:
  • Inability to complete all required training and assessments within the study timeline.
  • Language barriers:
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  • Insufficient proficiency in the language used for the study (e.g., English) to effectively communicate or understand the simulated patient interactions.
  • Health-related factors:
  • Conditions that may impair participation, such as significant hearing or vision impairment, or severe psychological conditions.
  • Prior participation in similar studies:
  • Students who have already participated in studies involving similar AI-based simulated patient training or feedback.
  • -

Trial locations and contacts

1 site in 1 country.

China1 site
  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

Other trials in China

About this study

Official title: Feasibility Study of Using GPT for History-taking Training in Medical Education

The goal of this clinical trial is to evaluate whether AI-based simulated patient training can improve clinical reasoning and history-taking skills in medical students. The main questions it aims to answer is:

Does GPT-based simulated patient training improve medical students' history-taking skills compared to traditional role-playing methods?

Read more

Participants will:

Participants in the intervention group perform medical history-taking conversations with an AI-simulated patient. Receive AI-generated structured feedback on their performance. The control group participated in role-playing exercises with instructors who acted as patients, receiving feedback after each session. Complete standardized assessments to evaluate clinical reasoning and decision-making skills.

Being tested
GPT-simulated patients, traditional role-playing
Keywords
History-taking Training, Artificial Intelligence, Medical Education, GPT Simulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GPT-simulated patientsBehavioural

    GPT-simulated patients

  • traditional role-playingBehavioural

    traditional role-playing

Study groups in NCT06766383
Study groupRoleWhat they receive
intervention groupExperimentalusing GPT-simulated patients
Receives: Behavioral: GPT-simulated patients
control groupActive comparatorusing traditional role-playing
Receives: Behavioral: traditional role-playing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. structured clinical examination to measure students' abilities in history taking

    Pre and Post Training: This primary endpoint measures improvements in students' clinical skills using a structured clinical examination conducted both before and after the training. The total score is out of 100 points, aggregated from four components:

    History Collection (30 points): Assesses the level of detail in the chief complaint and symptoms (10 points), the ability to understand and identify patient information (10 points), and the appropriateness and logic of follow-up questions (10 points).

    Clinical Reasoning (30 points): Evaluates the thoroughness of diagnostic thinking (15 points) and efficiency in processing information and forming clinical judgments (15 points).

    Communication Skills (20 points): Includes interaction with patients (10 points) and clarity of information delivery (10 points).

    Professional Behavior (20 points): Measures adherence to clinical procedural norms (10 points) and professional attitude towards patients (1

    Measured: From enrollment to the end of treatment at 4 weeks

Secondary outcomes (2)
  1. Training Feedback Assessment

    Training Feedback Assessment Measurement Tool: Structured Questionnaire on a 5-point Likert scale.

    Components Assessed:

    • Post-class self-directed learning.
    • Enthusiasm for learning.
    • Communication and feedback skills.
    • Expressiveness.
    • Interview logical reasoning ability.
    • Anxiety levels during the interview process. Description: This secondary endpoint collects feedback on the training methods' effectiveness through a structured questionnaire. Each aspect is rated on a 5-point Likert scale, where 1 indicates 'strongly disagree' and 5 indicates 'strongly agree'.

    Measured: From enrollment to the end of treatment at 4 weeks

  2. Student Satisfaction Survey

    Measurement Tool: Satisfaction Questionnaire on a 5-point Likert scale.

    Components Assessed:

    • Diversity of diseases encountered during training.
    • Naturalness of patient interaction.
    • Usability of the training methods.
    • Likelihood of recommending the training to peers. Description: This secondary endpoint evaluates student satisfaction concerning various aspects of the training experience. The questionnaire assesses each factor on a 5-point Likert scale, where 1 is 'very dissatisfied' and 5 is 'very satisfied'.

    Measured: From enrollment to the end of treatment at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start7 Oct 2024
  3. Primary completion15 Dec 2024
  4. Study completion15 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06766383
Sponsor's protocol ID
GPT for history-taking Trainin
Other IDs
2023jyxm1150
Acronym
SPAR-H
Status last verified
Oct 2024
First submitted
27 Dec 2024
Last updated
14 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wang Z, Fan TT, Li ML, Zhu NJ, Wang XC. Feasibility study of using GPT for history-taking training in medical education: a randomized clinical trial. BMC Med Educ. 2025 Jul 10;25(1):1030. doi: 10.1186/s12909-025-07614-9.

    PubMed 40640776

Questions about this trial

What is this clinical trial studying?

A study testing GPT-simulated patients and traditional role-playing in people with History-taking Training and GPT, run by zhen wang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

structured clinical examination to measure students' abilities in history taking (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06766383, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.

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