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

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 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


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

Value
https://center6.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