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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009238
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute Tokyo Metropolitan government
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010841

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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