UMIN-CTR Clinical Trial

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
Institute	Kyoto University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036005