UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058162 |
|---|---|
| Receipt number | R000066473 |
| Scientific Title | An Intervention Study and Effectiveness Evaluation of AI-Facilitated Educational Materials to Enhance Reflective Capacity in Healthcare Professionals |
| Date of disclosure of the study information | 2025/06/12 |
| Last modified on | 2025/06/12 13:49:04 |
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Basic information
Public title
Developing and Evaluating AI-Facilitated Educational Tools to Foster Reflective Practice among Healthcare Providers
Acronym
Enhancing Medical Reflection via AI Instruction
Scientific Title
An Intervention Study and Effectiveness Evaluation of AI-Facilitated Educational Materials to Enhance Reflective Capacity in Healthcare Professionals
Scientific Title:Acronym
Intervention and Evaluation of AI-Facilitated Reflection Training Materials for Healthcare Professionals
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop AI-facilitated instructors and evaluate their effectiveness in creating meaningful time for both instructors and learners, while providing psychologically safe and effective reflective opportunities for learners.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate and SpO2 will be monitored during interviews with the AI instructor, and an online questionnaire will be collected after the session. The results will be compared with those from interviews conducted with human instructors.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
interviews with the AI instructor
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
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Instructors who have participated in seminars or workshops on the R2C2 model and conduct learner interviews using the R2C2 approach, and their learners.
Key exclusion criteria
Persons with cognitive impairment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Miyoshi |
Organization
Kyoto University
Division name
Center for Medical Education and Internationalization
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-9454
miyoshi.tomoko.7z@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Person in charge |
| Middle name | |
| Last name | Person in charge |
Organization
Kyoto University
Division name
General Affairs and Planning Division
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-9301
Homepage URL
060kensui@mail2.adm.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-u.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
| 2025 | Year | 06 | Month | 12 | 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 | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 16 | 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
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066473
