UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001596
Receipt number R000001915
Scientific Title An open-label randomized trial of web-based educational program for diagnostic capability of skin tumor
Date of disclosure of the study information 2008/12/31
Last modified on 2009/12/24 13:12:45

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Basic information

Public title

An open-label randomized trial of web-based educational program for diagnostic capability of skin tumor

Acronym

A randomized trial of educational program for diagnostic capability of skin tumor

Scientific Title

An open-label randomized trial of web-based educational program for diagnostic capability of skin tumor

Scientific Title:Acronym

A randomized trial of educational program for diagnostic capability of skin tumor

Region

Japan


Condition

Condition

skin tumor

Classification by specialty

Medicine in general Dermatology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of web-based educational program with self-learning materials on diagnostic capability of skin tumor

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Scores of self-administered questionnaires about definitive diagnosis of skin tumor

Key secondary outcomes

Scores of self-administered questionnaires about differentiating skin cancer


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


Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Educational program group= Web-based educational program with self-learning materials+ ordinary learning with own sources

Interventions/Control_2

Control group= Ordinary learning with own sources

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

1. Medical doctors mainly engaging general or family practice.
2. Medical doctors fluent in Japanese.

Key exclusion criteria

1. Medical doctors mainly engaging dermatological practice.
2. Medical doctors working less than three days a week.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yosuke Yamamoto

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Epidemiology and Healthcare Research

Zip code


Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Epidemiology and Healthcare Research

Zip code


Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Japan Ministry of Health, Labor, and Welfare

Organization

Division

Category of Funding Organization

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

2008 Year 12 Month 31 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

Terminated

Date of protocol fixation

2008 Year 10 Month 03 Day

Date of IRB


Anticipated trial start date

2009 Year 01 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 12 Month 24 Day

Last modified on

2009 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001915


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name