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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013976
Receipt No. R000016278
Scientific Title Effectiveness of an Educational Intervention for Midwives about Early-Childhood Immunization
Date of disclosure of the study information 2014/05/16
Last modified on 2015/05/18

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Basic information
Public title Effectiveness of an Educational Intervention for Midwives about Early-Childhood Immunization
Acronym Effectiveness of an Immunization Educational Program for Midwives
Scientific Title Effectiveness of an Educational Intervention for Midwives about Early-Childhood Immunization
Scientific Title:Acronym Effectiveness of an Immunization Educational Program for Midwives
Region
Japan

Condition
Condition In-service midwives
Mothers have a month old infants
Classification by specialty
Obsterics and gynecology Pediatrics Nursing
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of an education program for midwives to provide immunization support to women in pre/post-partum period
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Primary outcome for midwives
A change in implementation rate of immunization support activities
(measured before, immediate after, one and two months after the intervention)

2. Primary outcome for mothers
Intention to immunize voluntary vaccines
(Hepatitis B and Rota virus) for their infants at a month old
Key secondary outcomes 1. Secondary outcome for midwives(measured before, immediate after, one and two months after the intervention)
1) A change in difficulties with providing immunization support activities
2) A change in attitudes and perception of immunization and its support activities
3) A change in knowledge test score

2. Secondary outcome for mothers
( 1) to 4) are measured at one month check-up)
1) Understanding of need for Rubella vaccination
2) Frequency of receiving immunization related supports by midwives
3) Preparedness for immunization (selection of medical facilities for initial vaccination)
4) Knowledge test score
5) Up-to-date status of initial vaccination at two months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention:provide the following 1-5
1. education program (an hour lecture)
2. a handout for immunization support activities
3. a list of information resource site
4. a booklet to self-study
5. in person and e-mail consultation
Interventions/Control_2 Control
Above 2-5.
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Midwives
1. who have opportunities to implement immunization support activities in their day-to-day work
2. who understand the purpose and method of this study and give consent in writing
3. who can participate the whole process of the study (taking part in the education program and filling out multiple questionnaire)

Mothers
1. who have one month old infants
2. who complete postpartum check-up
3. who understand the purpose and method of this study and respond in agreement
4. who are capable to understand and fill out the questionnaire in Japanese
*target sample size 204
Key exclusion criteria Prospective participants who do not meet any of the above-mentioned criteria
Target sample size 76

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeko Horiuchi
Organization St.Luke's International University
Division name Nursing Science, Women's Health&Midwifery
Zip code
Address 10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
TEL 03-3543-6391
Email shigeko-horiuchi@slcn.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Endo
Organization St.Luke's International University, Postgraduate School
Division name Nursing Science, Women's Health&Midwifery
Zip code
Address 8-5-3, Tsukiji, Chuo-ku, Tokyo,104-0045, Japan
TEL 03-6226-6361
Homepage URL
Email 12dn002a8e-ts@slcn.ac.jp

Sponsor
Institute St.Luke's International University
Institute
Department

Funding Source
Organization St.Luke's Life Science Institute
Organization
Division
Category of Funding Organization Non profit foundation
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
2014 Year 05 Month 16 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
2014 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 16 Day
Last modified on
2015 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016278

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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