Tokyo, Sept. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062976) titled 'Development and Evaluation of a Hybrid Learner Support Model Combining Generative AI and Human Coaching' on Sept. 18.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Chiba University

Condition: Condition - Fifth-year medical students during clinical clerkships. This is a medical education study and does not target a specific disease. Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - Coaching using generative AI Interventions/Control_2 - Without using generative AI coahing

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 Size - 90

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072105

Disclaimer: Curated by HT Syndication.