UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062976 |
|---|---|
| Receipt number | R000072105 |
| Scientific Title | Development and Evaluation of a Hybrid Learner Support Model Combining Generative AI and Human Coaching |
| Date of disclosure of the study information | 2026/09/18 |
| Last modified on | 2026/09/18 13:46:00 |
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Basic information
Public title
Development and Evaluation of a Hybrid Learner Support Model Combining Generative AI and Human Coaching
Acronym
Development and Evaluation of a Hybrid Learner Support Model Combining Generative AI and Human Coaching
Scientific Title
Development and Evaluation of a Hybrid Learner Support Model Combining Generative AI and Human Coaching
Scientific Title:Acronym
Development and Evaluation of a Hybrid Learner Support Model Combining Generative AI and Human Coaching
Region
| Japan |
Condition
Condition
Fifth-year medical students during clinical clerkships. This is a medical education study and does not target a specific disease.
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
o examine whether providing access to study-specific generative AI coaching during a three-week community-based clinical clerkship improves self-regulated learning compared with usual clerkship education and delayed access among fifth-year medical students who wish to use AI coaching. Secondary aims are to assess resilience, educational performance, and actual use. Students who do not wish to use AI coaching will be followed in a separate observational cohort to explore differences in learning trajectories compared with the wait-list group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline to the end of the three-week community-based clinical clerkship in the mean score of the 11-item Self-regulation subscale of the modified Motivated Strategies for Learning Questionnaire for medical students. The items are translated into Japanese and adapted to the clinical clerkship context. Each item is rated from 1 to 7; the score is the mean of the 11 items (range 1-7; higher scores indicate greater self-regulation). Change is calculated as post-clerkship minus baseline score. The primary comparison is between the stratified randomized immediate-access and wait-list groups. The post-clerkship assessment is completed before the wait-list group receives access to the study coaching.
Key secondary outcomes
1. Change in total Brief Resilience Scale Japanese version (BRS-J) score from baseline to the end of the three-week clerkship. Six items are rated on five-point scales; items 2, 4 and 6 are reverse-scored before summing (range 6-30; higher scores indicate greater resilience).
2. End-of-clerkship portfolio-based reflection assessment, number of clinical skill items attained, and number of clinical cases experienced, obtained from routine clerkship records.
3. Uptake (at least one session), number of sessions, total usage time, and number of weeks with use in the immediate-access group during the three weeks.
4. Perceived usefulness and burden at the end of the clerkship.
5. Reported psychological burden, inadvertent entry of personal information, and interference with clerkship activities during the three weeks. Associations between use and educational outcomes are exploratory.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Coaching using generative AI
Interventions/Control_2
Without using generative AI coahing
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
1. Fifth-year medical students enrolled at Chiba University School of Medicine who participate in the community-based clinical clerkship during the 2026 academic year.
2. Aged 18 years or older at the time of enrollment.
3. Able to understand the study information, questionnaires, and generative AI coaching conducted in Japanese.
4. Indicated in the baseline survey that they wished to use generative AI coaching during the community-based clinical clerkship.
5. Completed the baseline assessment, including the measure of self-regulated learning, before randomization.
6. Provided voluntary informed consent to participate in the study, including random allocation to either the immediate AI coaching group or the wait-list control group.
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
1. Those who do not provide informed consent for study participation or randomization.
2. Those who indicated in the baseline survey that they did not wish to use generative AI coaching during the community-based clinical clerkship.
3. Those for whom the baseline data required for assessment of the primary outcome cannot be obtained before randomization.
4. Those for whom participation in generative AI coaching is judged by the principal investigator to impose an excessive burden on the participant or interfere with the normal conduct of the clinical clerkship.
5. Duplicate registrations by the same participant.
6. Those otherwise judged by the principal investigator to be inappropriate for participation in the randomized controlled trial.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Shikino |
Organization
Chiba University Graduate School of Medicine
Division name
Community-Oriented Medical Education
Zip code
2608670
Address
Inohana 1-8-1, Chu-ou-ku, Chiba city
TEL
043-222-5239
kshikino@gmail.com
Public contact
Name of contact person
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Shikino |
Organization
Chiba University Graduate School of Medicine
Division name
Community-Oriented Medical Education
Zip code
260-8670
Address
Inohana 1-8-1, Chu-ou-ku, Chiba city
TEL
043-222-5239
Homepage URL
kshikino@gmail.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Graduate School of Medicine, Chiba University
Address
Inohana 1-8-1, Chu-ou-ku, Chiba-city
Tel
043-222-7171
inohana-rinri@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
千葉大学医学部（千葉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 18 | 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
| 2026 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 18 | Day |
Last modified on
| 2026 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072105
