UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053747 |
|---|---|
| Receipt number | R000061336 |
| Scientific Title | Development and Validation of a Medical Interview Training Program Using Generative Artificial Intelligence |
| Date of disclosure of the study information | 2024/03/02 |
| Last modified on | 2024/03/01 12:53:08 |
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Basic information
Public title
Development and Validation of a Medical Interview Training Program Using Generative Artificial Intelligence: A Crossover Pilot Study with a Face-to-Face Control Arm and a Generative AI Intervention Arm
Acronym
Development and Validation of a Medical Interview Training Program Using Generative Artificial Intelligence
Scientific Title
Development and Validation of a Medical Interview Training Program Using Generative Artificial Intelligence
Scientific Title:Acronym
Development and Validation of a Medical Interview Training Program Using Generative Artificial Intelligence
Region
| Japan |
Condition
Condition
Medicine in general
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to demonstrate the suitability of a Generative Artificial Intelligence-based medical interview training program learning environment compared to traditional face-to-face medical interview training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mini-CEX
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
Active
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
We will conduct a medical interview training using a generative AI. The training will consist of two parts:
1. A conversational generative AI medical interview using a simulated patient case.
2. An evaluation of the medical interview using the Mini-CEX (Mini-Clinical Evaluation Exercise).
The Mini-CEX evaluation will be conducted by both the generative AI and a physician who has reviewed the medical interview history.
Interventions/Control_2
We will conduct a face-to-face medical interview training. The training will consist of two parts:
1. A conversational medical interview using a simulated patient case.
2. An evaluation of the medical interview using the Mini-CEX (Mini-Clinical Evaluation Exercise).
The Mini-CEX evaluation will be conducted by both the generative AI and a physician who has reviewed the medical interview history.
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
1. A resident physician at Dokkyo Medical University Hospital
2. Individuals who have provided written informed consent after receiving a full explanation of the study
Key exclusion criteria
Individuals deemed ineligible by the researcher to participate in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Hirosawa |
Organization
Dokkyo Medical University
Division name
General Internal Medicine
Zip code
321-0293
Address
880 Kitakobayashi Mubu-cho Shimotsuga-gun Tochigi Japan
TEL
0282861111
hirosawa@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Hirosawa |
Organization
Dokkyo Medical University
Division name
General Internal Medicine
Zip code
321-0293
Address
880 Kitakobayashi Mubu-cho Shimotsuga-gun Tochigi Japan
TEL
0282861111
Homepage URL
hirosawa@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Takanobu Hirosawa
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University IRB
Address
880 Kitakobayashi Mubu-cho Shimotsuga-gun Tochigi Japan
Tel
0282861111
r-kenkyu@dokkyomed.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
| 2024 | Year | 03 | Month | 02 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | 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 | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061336
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
