UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056228
Receipt number R000064153
Scientific Title Evaluating the Usefulness of Artificial Intelligence Simulated Patients in Medical Interviewing
Date of disclosure of the study information 2024/11/21
Last modified on 2026/01/07 11:44:49

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Basic information

Public title

Evaluating the Usefulness of Artificial Intelligence Simulated Patients in Medical Interviewing

Acronym

Evaluating the Usefulness of Artificial Intelligence Simulated Patients in Medical Interviewing

Scientific Title

Evaluating the Usefulness of Artificial Intelligence Simulated Patients in Medical Interviewing

Scientific Title:Acronym

Evaluating the Usefulness of Artificial Intelligence Simulated Patients in Medical Interviewing

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objectives of this study are to give the AI the role of a simulated patient, conduct a simulated interview with a medical student, and evaluate its usefulness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Medical interviews with simulated AI patients and medical interviews with simulated human patients will be evaluated using the mini-CEX (mini-Clinical Evaluation Exercise).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

A medical student conducts a medical interview with a simulated human patient.

Interventions/Control_2

A medical student conducts a medical interview with a simulated AI patient.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

21 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

The inclusion criteria for this study are medical students on a general medicine rotation at Chiba University School of Medicine from December 2024 to September 2025.

Key exclusion criteria

Exclusions include failure to obtain consent to participate in the study and failure to carry out the medical interview to the end of the study.

Target sample size

88


Research contact person

Name of lead principal investigator

1st name Takanori
Middle name
Last name Uehara

Organization

Chiba University Hospital

Division name

General Medicine

Zip code

260-8677

Address

1-8-1, Inohana, Chuo-ku, Chiba city

TEL

043-222-7171

Email

takanori.ue@nifty.com


Public contact

Name of contact person

1st name Yasutaka
Middle name
Last name Yanagita

Organization

Chiba University Hospital

Division name

General Medicine

Zip code

260-8677

Address

1-8-1, Inohana, Chuo-ku, Chiba city

TEL

043-222-7171

Homepage URL


Email

ahna5650@chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Japan Medical Education Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University

Address

1-8-1, Inohana, Chuo-ku, Chiba city

Tel

043-222-7171

Email

igaku-rinri@office.chiba-u.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2024 Year 11 Month 21 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

NA

Number of participants that the trial has enrolled

48

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2024 Year 11 Month 11 Day

Date of IRB

2024 Year 11 Month 30 Day

Anticipated trial start date

2024 Year 12 Month 02 Day

Last follow-up date

2025 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 11 Month 21 Day

Last modified on

2026 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064153