UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013976 |
|---|---|
| Receipt number | 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 08:57:19 |
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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
| Obstetrics 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
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
12dn002a8e-ts@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016278
