UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039434 |
|---|---|
| Receipt number | R000044958 |
| Scientific Title | The flipped classroom is effective for medical students to improve funduscopic examination skills: A mixed methods study |
| Date of disclosure of the study information | 2020/02/08 |
| Last modified on | 2020/02/08 15:55:23 |
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Basic information
Public title
The flipped classroom is effective for medical students to improve funduscopic examination skills: A mixed methods study
Acronym
The flipped classroom is effective for medical students to improve funduscopic examination skills: A mixed methods study
Scientific Title
The flipped classroom is effective for medical students to improve funduscopic examination skills: A mixed methods study
Scientific Title:Acronym
The flipped classroom is effective for medical students to improve funduscopic examination skills: A mixed methods study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this research is to investigate the effectiveness of the flipped classroom teaching methodology compared to traditional teaching method for training medical students in fundoscopy. The purpose of this study is also to analyze how the educational effect of the flipped classroom has affected the performance of fundus examination by qualitative research.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic accuracy of funduscopic findings (ie, normal fundus, optic disc edema, pathological optic disc cupping, or not observed) and time taken to identify funduscopic findings were assessed in pre-test and post-test. Semi-structured focused group interview about teaching method.
Key secondary outcomes
Five-Likert scale questionnaires about the confidence of funduscopic examinations and motivation for funduscopic examinations were assessed before and after training session.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Flipped classroom teaching method in fundus examination
Interventions/Control_2
Traditional teaching method in fundus examination
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study population consisted of 104 medical students participating in a general medicine clerkship rotation from 2018 to 2019.
Key exclusion criteria
NA
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masatomi |
| Middle name | |
| Last name | Ikusaka |
Organization
Chiba University Hospital
Division name
General Medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chu-ou-ku
TEL
043-222-7171
ikusaka@ga2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Shikino |
Organization
Chiba University Hospital
Division name
General Medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chu-ou-ku
TEL
043-222-7171
Homepage URL
kshikino@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
NA
Other related organizations
Co-sponsor
NA
Name of secondary funder(s)
NA
IRB Contact (For public release)
Organization
Chiba University
Address
Chiba
Tel
043-222-7171
igaku-rinri@office.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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
104
Results
The mean diagnostic accuracy was scores of each post-test significantly increased from pre-test in both intervention and control groups. The mean diagnostic accuracy scores in the pre-test and post-test were 36.6% and 63.4 % in the intervention group, 28.3% and 34.6 % in the control group.
Results date posted
| 2020 | Year | 02 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We received consent from all 104 medical students and were able to complete the quantitative research. Six small groups (30 medical students) were able to complete the qualitative research. The mean age of the participants was 23.4 years, of which 75.0% were men. We found no statistically significant differences between the intervention control groups. None of the participants had prior clinical clerkship rotation in ophthalmology.
Participant flow
Writing consent form
Adverse events
NA
Outcome measures
Main outcome measures
The diagnostic accuracy of funduscopic findings (ie, normal fundus, optic disc edema, pathological optic disc cupping, or not observed) and time taken to identify funduscopic findings were assessed in pre-test and post-test.
Plan to share IPD
NA
IPD sharing Plan description
NA
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 08 | Day |
Last modified on
| 2020 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044958
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