UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043560 |
|---|---|
| Receipt number | R000049745 |
| Scientific Title | A Web-based Randomized Controlled Trial Investigating Efficacy of Behavioral Insights with Simple Scientific Information For Recovering Low-HPV Vaccination Rate in Japan |
| Date of disclosure of the study information | 2021/03/09 |
| Last modified on | 2021/03/09 13:58:42 |
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Basic information
Public title
A Web-based Randomized Controlled Trial Investigating Efficacy of Behavioral Insights with Simple Scientific Information For Recovering Low-HPV Vaccination Rate in Japan
Acronym
A Web-based Randomized Controlled Trial Investigating Efficacy of Behavioral Insights with Simple Scientific Information For Recovering Low-HPV Vaccination Rate in Japan
Scientific Title
A Web-based Randomized Controlled Trial Investigating Efficacy of Behavioral Insights with Simple Scientific Information For Recovering Low-HPV Vaccination Rate in Japan
Scientific Title:Acronym
A Web-based Randomized Controlled Trial Investigating Efficacy of Behavioral Insights with Simple Scientific Information For Recovering Low-HPV Vaccination Rate in Japan
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of these behavioral insights utilizing fundamental scientific information on vaccine benefits, along with statistics on cervical cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of the willingness on the daughter's vaccination
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
provided the BI-material prior to answering questions related to preventive awareness, following consent for the online study
Interventions/Control_2
provided with the same material as that provided to the intervention group after all responses were completed
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who are registered members of the research panel owned by Macromill, Inc. (Tokyo, Japan).
Key exclusion criteria
None
Target sample size
1660
Research contact person
Name of lead principal investigator
| 1st name | YUKIO |
| Middle name | |
| Last name | SUZUKI |
Organization
Yokohama City University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
0457872800
yetii18@yahoo.co.jp
Public contact
Name of contact person
| 1st name | YUKIO |
| Middle name | |
| Last name | SUZUKI |
Organization
Yokohama City University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
0457872800
Homepage URL
yetii18@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
the Japan Agency for Medical Research and Development
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
Institutional Research Ethics Committee of Yokohama City University School of Medicine
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
Tel
0457872800
yetii18@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
A180200004
Org. issuing International ID_1
Yokohama City University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 09 | 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
1660
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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049745
