UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059521 |
|---|---|
| Receipt number | R000068085 |
| Scientific Title | The influence of team-based learning in clinical reasoning education on medical students' self-regulated learning skills: A mixed-methods study |
| Date of disclosure of the study information | 2025/10/23 |
| Last modified on | 2025/10/23 17:15:15 |
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Basic information
Public title
The influence of team-based learning in clinical reasoning education on medical students' self-regulated learning skills: A mixed-methods study
Acronym
The influence of team-based learning in clinical reasoning education on medical students' self-regulated learning skills
Scientific Title
The influence of team-based learning in clinical reasoning education on medical students' self-regulated learning skills: A mixed-methods study
Scientific Title:Acronym
The influence of team-based learning in clinical reasoning education on medical students' self-regulated learning skills
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare students' self-assessments of their SRL skills before and after an educational intervention and to investigate the strengths of TBL in clinical reasoning education for medical students prior to clinical practice. Furthermore, it examines which elements of TBL enhance medical students' SRL skills from the perspective of their cognitive processes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Quantitative study
To investigate the effect of TBL on medical students' SRL skills prior to clinical practice, a cross-sectional study using questionnaires was conducted. The quantitative data in this study examined self-assessments of SRL skills via questionnaires before and after the TBL educational intervention.
2. Qualitative study
Following the quantitative evaluation, a qualitative evaluation was conducted to examine the effect of TBL on medical students' SRL skills from the perspective of their cognitive processes. For the qualitative data, an open-ended questionnaire survey was administered, and content analysis was used to examine which elements of TBL enhance medical students' SRL skills.
Key secondary outcomes
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
| 22 | years-old | <= |
Age-upper limit
| 31 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Fourth-year medical students enrolled at Yokohama City University School of Medicine
Participants in the Symptoms and Pathophysiology team-based learning (TBL) course (10 units)
Provided written informed consent after receiving a full explanation of the study
Key exclusion criteria
Students with incomplete data on pre- or post-intervention questionnaires or tests
Students who withdrew consent
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Ishizuka |
Organization
Department of General Medicine, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan
Division name
Department of General Medicine, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama-city, Kanagawa pref. Japan
TEL
045-787-2800
e103007c@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Ishizuka |
Organization
Department of General Medicine, Yokohama City University School of Medicine, Yokohama, Kanagawa, Jap
Division name
Department of General Medicine, Yokohama City University School of Medicine, Yokohama, Kanagawa, Jap
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama-city, Kanagawa pref. Japan
TEL
045-787-2800
Homepage URL
e103007c@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama Foundation for Medical Research and Education
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of General Medicine, Yokohama City University School of Medicine
Address
3-9 Fukuura, Kanazawa-ku, Yokohama-city, Kanagawa pref. Japan
Tel
0457872800
e103007c@yokohama-cu.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 | 10 | Month | 23 | 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
86
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2025 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068085
