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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012833
Receipt No. R000014992
Scientific Title The efficacy of multidisciplinary and comprehensive approaches of the stepwise perinatal immunization education to improve immunization status
Date of disclosure of the study information 2014/05/01
Last modified on 2016/02/15

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Basic information
Public title The efficacy of multidisciplinary and comprehensive approaches of the stepwise perinatal immunization education to improve immunization status
Acronym The efficacy of the stepwise immunization education
Scientific Title The efficacy of multidisciplinary and comprehensive approaches of the stepwise perinatal immunization education to improve immunization status
Scientific Title:Acronym The efficacy of the stepwise immunization education
Region
Japan

Condition
Condition vaccine preventable diseases
Classification by specialty
Infectious disease Obsterics and gynecology Pediatrics
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy of standardized immunization education shared with the common concept of multidisciplinary individual affecting to intent to vaccinate children in Japan where immunization education is not standarlized.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Immunization status of the following infantile vaccines at 6 months of age; rotavirus, hepatitis B, Haemophilus influenzae type b, pneumococcal conjugate, DPT+IPV(diphtheria, tetanus, pertussis, polio) vaccines
2. Changes in maternal knowledge, attitudes and beliefs between the pre- and post-study evaluation
Key secondary outcomes 1. The cost of implementing the intervention
2. Change in maternal intention to receive immunization between the pre- and post-study evaluation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Provide interactive immunization education and visual teaching materials for intervention group at three different stages: third trimester, within one week after birth and one month of age
Interventions/Control_2 For the control group, we provide only teaching materials which contain general contents of immunization at the third trimester
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 Uncomplicated pregnant women who were 18 years or older , who are 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 108

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoko Nagata
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Community Health Nursing, Division of Health Sciences and Nursing
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
TEL 03-5841-3597
Email satoko-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aya Saitoh
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Community Health Nursing, Division of Health Sciences and Nursing
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
TEL 03-5841-3597
Homepage URL
Email aya-saitoh@umin.ac.jp

Sponsor
Institute Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization St.Like's Science Institute
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2014 Year 05 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 The present results indicate that stepwise perinatal immunization education improved immunization schedule adherence and increased maternal knowledge of infant immunization practice. In addition, knowledge score was significantly improved by the intervention. These findings confirm the importance of perinatal immunization education. Future efforts should focus on developing a standardized perinatal immunization education system that improves infant immunization outcomes.
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 Completed
Date of protocol fixation
2013 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2015 Year 10 Month 30 Day
Date of closure to data entry
2015 Year 10 Month 30 Day
Date trial data considered complete
2015 Year 10 Month 30 Day
Date analysis concluded
2015 Year 11 Month 15 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 13 Day
Last modified on
2016 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014992

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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