UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062344 |
|---|---|
| Receipt number | R000071349 |
| Scientific Title | A Study on the Association between Learning Traits and Academic Performance in Medical Students (Phase 1) |
| Date of disclosure of the study information | 2026/07/28 |
| Last modified on | 2026/07/27 10:15:29 |
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Basic information
Public title
A questionnaire survey of medical students' attitudes and approaches to learning (learning traits) and their association with academic performance
Acronym
Learning Traits Study (Phase 1)
Scientific Title
A Study on the Association between Learning Traits and Academic Performance in Medical Students (Phase 1)
Scientific Title:Acronym
LTAP-1
Region
| Japan |
Condition
Condition
Not applicable (healthy adults: undergraduate medical students)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the association between learning traits and academic performance among undergraduate medical students at Tokai University School of Medicine. Five psychological traits (growth mindset, academic self-efficacy, self-regulated learning, help-seeking behavior, and intrinsic motivation) are measured using a 33-item, 6-point Likert questionnaire. Phase 1a is a prospective longitudinal cohort study of first-year students (T0: April 2026; T1: April 2027). Phase 1b is a cross-sectional study of second- to fourth-year students examining associations with cumulative GPA. No intervention is performed.
Basic objectives2
Others
Basic objectives -Others
Exploration of associations between learning traits and academic performance; this is educational research and does not evaluate safety or efficacy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Phase 1a: association between the mean scores of the five learning traits (growth mindset, academic self-efficacy, self-regulated learning, help-seeking behavior, intrinsic motivation) and first-year GPA (multiple regression analysis). Phase 1b: association between the same five trait scores and cumulative GPA (multiple regression analysis with academic year as a covariate).
Key secondary outcomes
Change in each learning trait score from T0 to T1; association between trait change and grade trajectory; association between help-seeking behavior and academic performance (exploratory analysis in the Japanese context); association between AI use and learning traits/academic performance; comparison of trait scores across academic years; measurement invariance of the 33-item factor structure across years (confirmatory factor analysis); comparison of factor loading patterns between Phase 1a (year 1) and Phase 1b (years 2-4).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Phase 1a: students who entered the medical course of Tokai University School of Medicine in academic year 2026 and who completed the learning-traits questionnaire (T0) at the freshman orientation. Phase 1b: students enrolled in year 2, 3 or 4 of the same course in academic year 2026 who voluntarily completed the questionnaire and checked the research-consent box.
Key exclusion criteria
Students who have difficulty responding in Japanese; students who did not consent to participate; for Phase 1a, students who opted out; for Phase 1b, students who did not check the research-consent box; students on leave of absence (cumulative GPA not comparable with that of other enrolled students).
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Tokai University School of Medicine
Division name
Department of Medical Education, Basic Medical Science
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL
0463-93-1121
hero@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Tokai University School of Medicine
Division name
Department of Medical Education, Basic Medical Science
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL
0463-93-1121
Homepage URL
hero@tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
Tel
0463-93-1121
tokai-rec@tokai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
26R032
Org. issuing International ID_1
Clinical Research Review Board, Tokai University School of Medicine
Study ID_2
26R032-001 M
Org. issuing International ID_2
Tokai University School of Medicine (institutional permission number)
IND to MHLW
Institutions
Institutions
東海大学医学部（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 28 | 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 | 06 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
This is a non-interventional observational study examining the association between learning traits and academic performance in medical students.
Exposures examined: five learning traits (growth mindset, 6 items; academic self-efficacy, 6 items; self-regulated learning, 8 items; help-seeking behavior, 5 items; intrinsic motivation, 8 items; 33 items in total on a 6-point Likert scale, including 7 reverse-scored items) and three items on the use of AI tools.
Outcome: academic performance (Phase 1a: first-year GPA; Phase 1b: cumulative GPA; both provided by the academic affairs unit).
Design: Phase 1a is a prospective longitudinal cohort (T0: 6 April 2026; a single follow-up T1 in April 2027). Phase 1b is a cross-sectional cohort.
Sampling: all students enrolled in the target academic years are invited; participation is voluntary.
Data collection: Microsoft Forms. In Phase 1a the student ID is replaced with a study ID and the linkage table is kept by the principal investigator. In Phase 1b the linkage table is held by the academic affairs unit and only pseudonymized data are provided to the investigators.
The Phase 1a T0 data were already collected on 6 April 2026 as part of the institutional research (IR) activity of the school. They will be used secondarily for research purposes after ethics approval and institutional permission, following a 14-day opt-out period. Phase 1b and the T1 follow-up survey involve new data collection after approval.
Management information
Registered date
| 2026 | Year | 07 | Month | 27 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071349
