UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030130
Receipt number R000034399
Scientific Title A intervention study of Brazilian and Japanese mothers with young children in Japan to enhance disaster preparedness
Date of disclosure of the study information 2017/12/04
Last modified on 2018/11/28 11:22:43

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Basic information

Public title

A intervention study of Brazilian and Japanese mothers with young children in Japan to enhance disaster preparedness

Acronym

disaster preparedness

Scientific Title

A intervention study of Brazilian and Japanese mothers with young children in Japan to enhance disaster preparedness

Scientific Title:Acronym

disaster preparedness

Region

Japan


Condition

Condition

disaster

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

: To clarify the state of disaster preparedness of women who bring up under four years children for survival for 3 days, and their affecting factors; To verify the stage shift after educational intervention program for earthquake preparedness, and the differences between Japanese and Brazilian women.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intervation study
The intervention effect will be evaluated.
assessing level of awareness
intension and behavior
Prof Paton questionnaire for the social cognitive preparation model

Ovsevation study
assessing level of awareness
intension and behavior
Prof Paton questionnaire for the social cognitive preparation model

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are 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

Other

Interventions/Control_1

Educational program of disaster prevention and reduction for Japanese women

between January and October in 2018

Interventions/Control_2

Educational program of disaster prevention and reduction for Brazilian women

between January and October in 2018

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Japanese and Brazilian women who bring up under four years children

Key exclusion criteria

under twenty years women

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hatashita Hiroyo

Organization

Mie university

Division name

Graduate school of medicine

Zip code


Address

2-174 Edobashi Tsu city, Mie

TEL

0592315274

Email

hihatash@nurse.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hatashita Hiroyo

Organization

Mie university

Division name

Graduate school of medicine

Zip code


Address

2-174 Edobashi Tsu city, Mie

TEL

0592315274

Homepage URL


Email

hihatash@nurse.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie university

Institute

Department

Personal name



Funding Source

Organization

Mie university

Organization

Division

Category of Funding Organization

Other

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

2017 Year 12 Month 04 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

Preinitiation

Date of protocol fixation

2017 Year 11 Month 29 Day

Date of IRB


Anticipated trial start date

2017 Year 12 Month 05 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

2017 Year 11 Month 27 Day

Last modified on

2018 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034399


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name