UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052345 |
|---|---|
| Receipt number | R000059759 |
| Scientific Title | Research on Easy-to-understand Medical Information |
| Date of disclosure of the study information | 2023/09/28 |
| Last modified on | 2023/09/28 22:32:45 |
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Basic information
Public title
Research on Easy-to-understand Medical Information
Acronym
Research on Easy-to-understand Medical Information
Scientific Title
Research on Easy-to-understand Medical Information
Scientific Title:Acronym
Research on Easy-to-understand Medical Information
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will examine whether providing medical information at the readability level of elementary school students using plain Japanese will lead to an improvement in the level of understanding of general Japanese adults, compared with providing medical information at the readability level of junior high school students.
Basic objectives2
Others
Basic objectives -Others
Comprehensibility of medical information
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
True/False comprehension test scores
Key secondary outcomes
Perceived understanding
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Reading comprehension of medical information (Medical information in elementary school readability level)
Interventions/Control_2
Reading comprehension of medical information (Medical information in junior high school readability level)
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese men and women in their 20s to 50s who are registered on the monitor of a research company (MACROMILL, INC.).
Key exclusion criteria
The exclusion criteria are those whose mother tongue is not Japanese, those who work or have worked as a health care professional, those trained or in training as health care professionals, those who are university students, and those who have a bachelor's degree or higher as their final educational background.
Target sample size
464
Research contact person
Name of lead principal investigator
| 1st name | Hirono |
| Middle name | |
| Last name | Ishikawa |
Organization
Teikyo University Graduate School
Division name
Public Health
Zip code
173-8605
Address
2-11-1,Kaga,Itabashi-ku,Tokyo
TEL
03-3964-1211
hirono-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Omura |
Organization
Teikyo University Graduate School
Division name
Public Health
Zip code
173-8605
Address
2-11-1,Kaga,Itabashi-ku,Tokyo
TEL
03-3964-1211
Homepage URL
22pm20005ns@stu.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University Graduate School of Public Health
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)-Japan
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
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2-11-1,Kaga,Itabashi-ku,Tokyo 173-8605
Tel
03-3964-7256
turb-office@teikyo-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 | 09 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 10 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059759
