UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of standardized education with the American Academy of Pediatrics and the Japan Pediatric Society established the joint project
Title of the study (Brief title)	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	Aya Saitoh
Organization	St.Luke's International University
Division name	Graduate School of Nursing Science
Address	10-1 Akashi-cho, chuo-ku,Tokyo
TEL	0335436391
Email	ayasaitoh8@slcn.ac.jp

Public contact
Name of contact person	Aya Saitoh
Organization	St.Luke's International University
Division name	Graduate School of Nursing Science
Address	10-1 Akashi-cho, chuo-ku,Tokyo
TEL	0335436391
Homepage URL
Email	ayasaitoh8@slcn.ac.jp

Sponsor
Institute	Japan Society for the Promotion of Science
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039366