UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047906 |
|---|---|
| Receipt number | R000054610 |
| Scientific Title | Electronic vaccination record as the basis of the next-generation electronic maternal and child health handbook |
| Date of disclosure of the study information | 2022/05/31 |
| Last modified on | 2023/12/01 10:55:45 |
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Basic information
Public title
Electronic vaccination record and its effectiveness
Acronym
Electronic vaccination record and its effectiveness
Scientific Title
Electronic vaccination record as the basis of the next-generation electronic maternal and child health handbook
Scientific Title:Acronym
Electronic vaccination record as the basis of the next-generation electronic maternal and child health handbook
Region
| Japan |
Condition
Condition
Vaccine Preventable Diseases
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a PHR (personal health record) system that uses a card with a built-in IC chip for short-range wireless communication (NFC), we will verify the effect of suppressing vaccination errors in the field.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of electronic vaccination records and the number of vaccinations without error
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Infants who live in Kawasaki-ku, Kawasaki City and have never been vaccinated at the time of recruitment
Key exclusion criteria
Infants scheduled to move out of Kawasaki-ku
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Shinjoh |
Organization
Keio University School of Medicine
Division name
Department of Pediatrics
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3816
m-shinjo@keio.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Narabayashi |
Organization
Kawasaki Municipal Hospital
Division name
Department of Pediatrics
Zip code
210-0013
Address
12-1 Shinkawadori, Kawasaki-ku, Kawasaki, Kanagawa, Japan
TEL
044-233-5521
Homepage URL
naraba@2000.jukuin.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Institute of Industrial Science and Technology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
N/A
med-rinri-jimu@adst.keio.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
| 2022 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Registered an infant who lives in Kawasaki-ku, Kawasaki City and has never been vaccinated at the time of recruitment. Register until 2023/3/31.
Management information
Registered date
| 2022 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054610
