UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035045 |
|---|---|
| Receipt number | R000039366 |
| Scientific Title | The effect of standardized education with the American Academy of Pediatrics and the Japan Pediatric Society established the joint project |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2018/10/16 17:04:14 |
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Basic information
Public title
The effect of standardized education with the American Academy of Pediatrics and the Japan Pediatric Society established the joint project
Acronym
The effect of japanese version VIS
Scientific Title
The effect of standardized education with the American Academy of Pediatrics and the Japan Pediatric Society established the joint project
Scientific Title:Acronym
The effect of japanese version VIS
Region
| Japan |
Condition
Condition
Vaccine preventable diseases
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the effectiveness of immunization education using japanese Vaccine Information Statement offered at different perinatal period on the infantile immunization status and knowledge, attitudes and beliefs regarding immunization, and intent to vaccinate infants in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
up-to-date immunization status
Key secondary outcomes
immunization schedule adherence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Immunization education using japanese version vaccine information statement will be provided to the intervention group on 4 occasions: 1) 2 month old, 2) 3 month old , 3) 4-month old, 4) 5 month old, in an outpatient setting at a hospital or clinic.
Interventions/Control_2
For the control group, we provide only teaching materials which contain general contents of immunization
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
Female
Key inclusion criteria
Mother aged 18 years or older who were able to communicate in Japanese
Key exclusion criteria
Subjects with cognitive impairment, or subjects who suffer from physical or mental burden by the investigation, which are judged by the investigators or medical professionals
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aya Saitoh |
Organization
St.Luke's International University
Division name
Graduate School of Nursing Science
Zip code
Address
10-1 Akashi-cho, chuo-ku,Tokyo
TEL
0335436391
ayasaitoh8@slcn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Saitoh |
Organization
St.Luke's International University
Division name
Graduate School of Nursing Science
Zip code
Address
10-1 Akashi-cho, chuo-ku,Tokyo
TEL
0335436391
Homepage URL
ayasaitoh8@slcn.ac.jp
Sponsor or person
Institute
Japan Society for the Promotion of Science
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 02 | Month | 01 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2018 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039366
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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