UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009238 |
|---|---|
| Receipt number | R000010841 |
| Scientific Title | Promoting VZV immunization through face-to-face education. |
| Date of disclosure of the study information | 2012/11/05 |
| Last modified on | 2013/05/11 13:33:48 |
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Basic information
Public title
Promoting VZV immunization through face-to-face education.
Acronym
Promoting VZV immunization through face-to-face education.
Scientific Title
Promoting VZV immunization through face-to-face education.
Scientific Title:Acronym
Promoting VZV immunization through face-to-face education.
Region
| Japan |
Condition
Condition
Varicella
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether medical doctor's advice for varicella vaccine can change parental behavior and immunization rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase in parental awareness of varicella vaccination after detailed explanation.
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Children over 1-year-old who is admitted to General Pediatrics.
2)Written consent is obtained before our clinical resarch.
Key exclusion criteria
1)Patients who have already been
infected with varicella.
2)Patients contradicated for varicella immunization.
3)Pediatricians judged disqualified patients to this study.
4)Patients who have already subjects for this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Hasegawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of General Pediatrics
Zip code
Address
2-8-29 Musashidai, Fuchu-city, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chihiro Iwasaki |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of General Pediatrics
Zip code
Address
2-8-29 Musashidai, Fuchu-city, Tokyo
TEL
042-300-5111
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan government
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2012 | Year | 11 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)First questionnaire is returned after consent is obtained.
2)Detailed explanation about varicella immunization is performed.
3)Second questionnaire is returned after VZV immunization education.
4)Phone survey is conducted to confirm whether immunized or not 90(76-104)days after discharge.
Management information
Registered date
| 2012 | Year | 11 | Month | 01 | Day |
Last modified on
| 2013 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010841
