UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051391 |
|---|---|
| Receipt number | R000057833 |
| Scientific Title | A study on the dissemination and implementation of the e-learning material on evidence-based medicine for laypersons: investigation of learning effectiveness by target group characteristics and needs for additional materials |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2026/06/21 20:28:19 |
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Basic information
Public title
A study on the dissemination and implementation of the e-learning material on evidence-based medicine for laypersons
Acronym
A study on the dissemination and implementation of the e-learning material on evidence-based medicine for laypersons
Scientific Title
A study on the dissemination and implementation of the e-learning material on evidence-based medicine for laypersons: investigation of learning effectiveness by target group characteristics and needs for additional materials
Scientific Title:Acronym
A study on the dissemination and implementation of the e-learning material on evidence-based medicine for laypersons
Region
| Japan |
Condition
Condition
Nothing in particular
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate learning effectiveness by target group characteristics and needs for additional materials about the e-learning material on evidence-based medicine for laypersons.
Basic objectives2
Others
Basic objectives -Others
Exploration of effectiveness and needs
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in the mean of the total number of responses rated as "very confident" or "confident" in terms of confidence among the responses that correctly answered 18 questions about knowledge before and after the use of the material.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Using the e-learning material
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Using Internet on a daily basis
Key exclusion criteria
Having difficulty to read and write on website.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Satoe |
| Middle name | |
| Last name | Okabayashi |
Organization
Kyoto University
Division name
Agency for Health, Safety and Environment
Zip code
606-8501
Address
Yoshida Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2412
okabayashi.satoe.8c@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | "Health Information Nattokun" |
| Middle name | |
| Last name | Research Office |
Organization
Kyoto University
Division name
Agency for Health, Safety and Environment
Zip code
606-8501
Address
Yoshida Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2412
Homepage URL
nattokun-trial@hc2.hoken.kyoto-u.ac.jp
Sponsor or person
Institute
University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
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
ethcom@kuhp.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
| 2023 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000057833
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000057833
Number of participants that the trial has enrolled
530
Results
The mean number of questions answered correctly with confidence for the entire group was 8.75 (standard deviation [SD] 4.68) before using the educational materials and 10.37 (SD 5.42) after using them, with a difference of 1.62 (SD 2.96). The mean number of correct answers was 11.77 (SD 3.77) before using the teaching materials and 12.72 (SD 3.94) after using them, with a difference of 0.94 (SD 2.27).
The result was presented at "Health Communication Week 2025".
Results date posted
| 2026 | Year | 06 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were 530 participants, 52 of whom had prior training in epidemiology and evidence-based medicine or held national medical licenses.
Participant flow
Among the participants, 448 responded to the questions administered both before and after using the educational materials; of these, 42 had prior training in epidemiology and EBM or held a national medical license, while 406 did not.
Adverse events
None.
Outcome measures
The primary outcome measure was the mean number of questions answered correctly with confidence, and the secondary outcome measure was the mean number of correct answers.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2023 | Year | 06 | Month | 20 | Day |
Last modified on
| 2026 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057833
