UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012833 |
|---|---|
| Receipt number | 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 13:46:09 |
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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 | Obstetrics 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
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
aya-saitoh@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014992
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