UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031371
Receipt number R000035823
Scientific Title 5x5 Approach for educating clinical reasoning to residents
Date of disclosure of the study information 2018/03/30
Last modified on 2020/02/21 10:05:04

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Basic information

Public title

5x5 Approach for educating clinical reasoning to residents

Acronym

5x5 Approach for educating clinical reasoning to residents

Scientific Title

5x5 Approach for educating clinical reasoning to residents

Scientific Title:Acronym

5x5 Approach for educating clinical reasoning to residents

Region

Japan


Condition

Condition

residents

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We developed a new 5x5 Approach for clinical reasoning.
The purpose of this study is to evaluate the efficacy of this approach for resident education.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

diagnoses for case summaries

Key secondary outcomes

the confidence for the diagnoses


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

lecture about 5x5 Approach (1 hour)

Interventions/Control_2

lecture about medical care security (1 hour)

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 first year residents of 2018 fiscal year.

Key exclusion criteria

In case there is no consent, and absence from the lecture.

Target sample size

110


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name 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

Zip code


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

1st name
Middle name
Last name 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

Zip code


Address

1-5-45 Yushima, Bunkyo-ku,Tokyo 113-8510,JAPAN

TEL

03-5803-5948

Homepage URL


Email

shimozono.merd@tmd.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 03 Month 30 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

2018 Year 03 Month 27 Day

Date of IRB

2018 Year 03 Month 29 Day

Anticipated trial start date

2018 Year 03 Month 30 Day

Last follow-up date

2018 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 19 Day

Last modified on

2020 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035823


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name