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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039434
Receipt No. 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

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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
Email 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
Email kshikino@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044958

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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