UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032739
Receipt number R000036005
Scientific Title Effectiveness of an e-learning program on evidence-based-medicine for lay persons with interest
Date of disclosure of the study information 2018/06/10
Last modified on 2021/05/30 23:02:02

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Basic information

Public title

Effectiveness of an e-learning program on evidence-based-medicine for lay persons with interest

Acronym

Effectiveness of an e-learning program on evidence-based-medicine for lay persons with interest

Scientific Title

Effectiveness of an e-learning program on evidence-based-medicine for lay persons with interest

Scientific Title:Acronym

Effectiveness of an e-learning program on evidence-based-medicine for lay persons with interest

Region

Japan


Condition

Condition

Not particularly limited

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of the originally developed e-learning program of evidence-based medicine for Japanese lay persons

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The mean value of knowledge-test score (answered correctly with confidence) right after watching the e-learning program

Key secondary outcomes

1. The mean value of knowledge-test score (answered correctly with confidence) four weeks after watching the e-learning program
2. The mean value of knowledge-test score (answered correctly) right after watching the e-learning program
3. The mean value of knowledge-test score (answered correctly) four weeks after watching the e-learning program
4. The change of the score of "Communicative and Critical Health Literacy" between baseline and right after watching the e-learning program
5. The change of the score of "Communicative and Critical Health Literacy" between baseline and four weeks after watching the e-learning program


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

To watch whole part of the originally developed e-learning program on evidence-based medicine and epidemiology for Japanese lay persons (only once on the study day)

Interventions/Control_2

To watch only introduction part of the originally-developed e-learning program on evidence-based medicine and epidemiology for Japanese lay persons (only once on the study day)

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Using the Internet in daily life

Key exclusion criteria

1. Qualified healthcare professionals (doctors, dentists, nurses, pharmacists, midwives, public health nurses, physiotherapists, occupational therapists, nutritionists/administrative dieticians, medical radiology technicians, clinical laboratory technicians, and so on)
2. Undergraduate/postgraduate students of medicine/dentistry/pharmacy/nursing/other healthcare professional schools
3. Graduates of medicine/dentistry/pharmacy/nursing/other healthcare professional schools
4. Those who have systematically studied evidence-based medicine and epidemiology

Target sample size

130


Research contact person

Name of lead principal investigator

1st name Satoe
Middle name
Last name Okabayashi

Organization

Kyoto University

Division name

Health Service

Zip code

606-8501

Address

Yoshida-Honmachi, Sakyo-ku, Kyoto, JAPAN

TEL

075-753-2435

Email

okabayashi.satoe.8c@kyoto-u.ac.jp


Public contact

Name of contact person

1st name Research Secretariat of Kenko Joho Nattokun
Middle name
Last name Research Secretariat of Kenko Joho Nattokun

Organization

Kyoto University

Division name

Health Service

Zip code

606-8501

Address

Yoshida-Honmachi, Sakyo-ku, Kyoto, JAPAN

TEL

075-753-2435

Homepage URL


Email

nattokun-trial@hc2.hoken.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

075-753-4680

Email

ethcom@uhp.kyoto-u.ac.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

2018 Year 06 Month 10 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

122

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Because the results have not been published yet.

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 05 Month 22 Day

Date of IRB

2018 Year 06 Month 12 Day

Anticipated trial start date

2018 Year 11 Month 27 Day

Last follow-up date

2020 Year 01 Month 04 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 05 Month 28 Day

Last modified on

2021 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036005