UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of a new systematic method of the pathophysiology on the resident education.
Title of the study (Brief title)	The efficacy of a new systematic method of pathophysiology on the resident education.
Region	Japan

Condition
Condition	The residents
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We developed a new systematic method of the pathophysiology, which is the most important for the physicians. The purpose of this study is to evaluate the efficacy of this new method for the residents, and to compare the efficacy between the live lecture and the online lecture.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The evaluation is the record of an examination. The examination is held just before, just after, and 5 months after the lecture.
Key secondary outcomes	the results of a questionnare.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	One group will attend the live lecture for an hour, and after that they will receive the synopsis and the case practices.
Interventions/Control_2	The other group will attend the online lecture, and be able to receive the lecture online repeatedly, practice cases online after that.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The residents of 2017 fiscal year.
Key exclusion criteria	In case there is no consent, and the absence from the lecture.
Target sample size	200

Research contact person
Name of lead principal investigator	Makoto Takahashi
Organization	Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University (TMDU)
Division name	Department of Medical Education Research and Development
Address	1-5-45 Yushima, Bunkyo-ku,Tokyo 113-8510,JAPAN
TEL	03-5803-5948
Email	takahashi.merd@tmd.ac.jp

Public contact
Name of contact person	Hisashi Shimozono
Organization	Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University (TMDU)
Division name	Department of Medical Education Research and Development
Address	1-5-45 Yushima, Bunkyo-ku,Tokyo 113-8510,JAPAN
TEL	03-5803-5948
Homepage URL
Email	shimozono.merd@tmd.ac.jp

Sponsor
Institute	Department of Medical Education Research and Development, Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University (TMDU)
Institute
Department

Funding Source
Organization	Department of Medical Education Research and Development, Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University (TMDU)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	東京医科歯科大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 08 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 08 Day
Last modified on	2018 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027113