UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041435
Receipt number R000047280
Scientific Title The impact of medical interview assistance system using an artificial intelligence for medical interns on simulated patients: a crossover randomized controlled trial.
Date of disclosure of the study information 2020/09/01
Last modified on 2022/09/30 08:32:16

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Basic information

Public title

The impact of medical interview assistance system using an artificial intelligence for medical interns on simulated patients: a crossover randomized controlled trial.

Acronym

The impact of medical interview assistance system using an artificial intelligence for medical interns on simulated patients: a crossover randomized controlled trial.

Scientific Title

The impact of medical interview assistance system using an artificial intelligence for medical interns on simulated patients: a crossover randomized controlled trial.

Scientific Title:Acronym

The impact of medical interview assistance system using an artificial intelligence for medical interns on simulated patients: a crossover randomized controlled trial.

Region

Japan


Condition

Condition

General medical disorders

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to verify the effectiveness of the medical interview assistance system using an artificial intelligence.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Accuracy of differential diagnosis

Key secondary outcomes

Time required for medical interview


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

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Medical interviews with medical interview assistance system using an artificial intelligence.
Interviews are conducted 10 times in total, with 5 times using the assistance system.

Interventions/Control_2

Medical interviews without assistance system using an artificial intelligence.
Interviews are conducted 10 times in total, without 5 times using the assistance system.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Medical interns in their first year after graduating who voluntarily agreed to participate in the study.

Key exclusion criteria

1. Medical interns who did not get consent to participate in the research.
2. Medical interns who have been judged by researchers to be inappropriate as research subjects.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Kazutoshi
Middle name
Last name Fujibayashi

Organization

Juntendo University School of Medicine

Division name

Department of General Medicine

Zip code

113-8421

Address

3-1-3, Hongo, Bunkyo-Ku, Tokyo 113-8421, Japan

TEL

03-5802-1190

Email

kfujiba@juntendo.ac.jp


Public contact

Name of contact person

1st name Kazutoshi
Middle name
Last name Fujibayashi

Organization

Juntendo University School of Medicine

Division name

Department of General Medicine

Zip code

113-8421

Address

3-1-3, Hongo, Bunkyo-Ku, Tokyo 113-8421, Japan

TEL

03-5802-1190

Homepage URL


Email

kfujiba@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Self-procurement

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee Faculty of Medicine, Juntendo University

Address

3-1-3, Hongo, Bunkyo-Ku, Tokyo 113-8421, Japan

Tel

03-5802-1584

Email

hongo-rinri@juntendo.ac.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

2020 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

20

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

2019 Year 08 Month 20 Day

Date of IRB

2019 Year 09 Month 10 Day

Anticipated trial start date

2019 Year 09 Month 15 Day

Last follow-up date

2019 Year 11 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 17 Day

Last modified on

2022 Year 09 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047280


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name