UMIN-CTR Clinical Trial

Basic information
Public title	Effect of iExaminer teaching method on fundus examination skills: A randomized controlled trial
Acronym	Effect of iExaminer teaching method on fundus examination skills: A randomized controlled trial
Scientific Title	Effect of iExaminer teaching method on fundus examination skills: A randomized controlled trial
Scientific Title:Acronym	Effect of iExaminer teaching method on fundus examination skills: A randomized controlled trial
Region	Japan

Condition
Condition	Medical students
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Our objective was to compare the effect of the iExaminer teaching method with the traditional method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The diagnostic accuracy of funduscopic findings selected from normal fundus, optic disc edema, pathological optic disc cupping, or not observed, and time taken to identify funduscopic findings were assessed in pre/post-test.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	teaches fundus examination skills while sharing screens with students in the iExaminer teaching method using the iExaminer system).
Interventions/Control_2	Faculty teaches fundus examination skills while the student describes what they see to the faculty in the traditional teaching method not using the iExaminer system.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	This study participant consisted of medical students in general medicine clinical clerkship rotation from 2017 to 2018.
Key exclusion criteria	Students who can not agree with this research were excluded.
Target sample size	115

Research contact person
Name of lead principal investigator	1st name Kiyoshi Middle name Last name Shikino
Organization	Chiba University Hospital
Division name	Department of General Medicine
Zip code	260-8677
Address	1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba pref. Japan
TEL	043-222-7171
Email	kshikino@gmail.com

Public contact
Name of contact person	1st name Kiyoshi Middle name Last name Shikino
Organization	Chiba University Hospital
Division name	Department of General Medicine
Zip code	260-8677
Address	1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba pref. Japan
TEL	043-222-7171
Homepage URL
Email	kshikino@gmail.com

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the Ethics Committee of Chiba University School of Medicine
Address	1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba pref. Japan
Tel	043-226-2501
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

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	115
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	2017 Year 03 Month 18 Day
Date of IRB	2017 Year 07 Month 18 Day
Anticipated trial start date	2017 Year 07 Month 18 Day
Last follow-up date	2018 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 17 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042639