UMIN-ICDS Clinical Trial

Public title

A study to validate educational interventions and assessment tools for behavioral economics dialogue skills using AI-simulated patients in diabetes care.

Acronym

Educational Study on Diabetes Communication Skills using AI Simulated Patients

Scientific Title

Educational intervention for behavioral economic communication skills using AI-simulated patients in diabetes care and validation of an assessment tool: A three-group comparative study among junior, specialty-trained, and expert physicians

Scientific Title:Acronym

3-Group Comparison of AI-Simulated Patient Education for Diabetes

Region

Japan

Condition

Type 2 Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the educational efficacy (improvement in communication skills and self-efficacy) of behavioral economic communication training using AI-simulated patients among junior, specialty-trained, and expert physicians. This study also aims to compare the learning effects across these three experience levels and validate the construct validity of the AI-based scoring system using the expert physicians' dialogue data as a benchmark.

Basic objectives2

Others

Basic objectives -Others

Verification of educational intervention efficacy

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change in AI-generated total score for behavioral economic communication skills from Pre-test to Post-test (approximately 40-50 minutes after the start of the study).

Key secondary outcomes

Change in self-efficacy (confidence levels, Q1-Q4) from Pre-test to Post-test.

Change in the number of dialogue turns (rounds of conversation) required to reach a consensus with the AI patient.

Mean scores of the System Usability Scale (SUS) in the post-intervention questionnaire.

Comparison of baseline AI-generated scores among the three groups (junior, specialty-trained, and expert physicians) to verify construct validity.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

A single session of behavioral economic communication training using AI-simulated patients (interaction with 3 cases and reviewing feedback, approx. 40-50 min) for three cohorts: (1) junior physicians (3-7 years post-grad), (2) specialty-trained physicians in Endocrinology and Diabetes, and (3) board-certified diabetologists.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

24

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Physicians who provided written informed consent.

Physicians meeting any of the following: Junior physicians (3-7 years post-grad), Specialty-trained physicians in Endocrinology and Diabetes (without Diabetology Board certification), or Board-certified Diabetologists.

Key exclusion criteria

Those who have difficulty preparing an internet environment or device.

Those judged inappropriate by the principal investigator.

Target sample size

43

Name of lead principal investigator

1st name	Ichiro
Middle name
Last name	Nojima

Organization

Okayama University Hospital

Division name

Dept. of Nephrology, Rheumatology, Endocrinology and Metabolism

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama

TEL

086-235-7235

Email

kohaku8551@yahoo.co.jp

Name of contact person

1st name	Ichiro
Middle name
Last name	Nojima

Organization

Okayama University Hospital

Division name

Dept. of Nephrology, Rheumatology, Endocrinology and Metabolism

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama

TEL

086-235-7235

Homepage URL

Email

kohaku8551@yahoo.co.jp

Institute

Okayama University Hospital

Institute

Department

Personal name

Wada Jun

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Okayama University Hospital Institutional Review Board

Address

2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan

Tel

086-235-6938

Email

mae6605@adm.okayama-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岡山大学病院(岡山県)、岡山済生会総合病院（岡山県）、岡山医療センター（岡山県）、岡山市立市民病院（岡山県）、倉敷中央病院（岡山県）

Date of disclosure of the study information

2026

Year

06

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

06

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

07

Month

01

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

04

Month

30

Day

Last modified on

2026

Year

04

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070279