UMIN-CTR Clinical Trial
| 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 (Ver. 1) |
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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 | |
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| Condition | ||
| Condition | Not applicable | |
| Classification by specialty |
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| 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 |
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| Interventions/Control_1 | Flipped classroom teaching method in fundus examination | |
| Interventions/Control_2 | Traditional teaching method in fundus examination | |
| Interventions/Control_3 | ||
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| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| 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 | |||||||
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| Name of contact person |
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| 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 | |
| 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 |
| 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 |
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| Date of disclosure of the study information |
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| 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. |
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| Results date posted |
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| 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. |
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| Participant flow | Writing consent form |
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| Adverse events | NA |
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| 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. |
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| Plan to share IPD | NA | ||||||
| IPD sharing Plan description | NA | ||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044958 |
