UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051447 |
|---|---|
| Receipt number | R000055840 |
| Scientific Title | The Development of an Educational Program for Earthquake Preparedness of Mothers with Infants and its Effectiveness in a Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/06/26 |
| Last modified on | 2023/06/26 09:15:12 |
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Basic information
Public title
The Effectiveness of an Educational Intervention on Earthquake Preparedness for Mothers with their Infants
Acronym
The Effectiveness of a Disaster Prevention Educational Program for Mothers with Infants
Scientific Title
The Development of an Educational Program for Earthquake Preparedness of Mothers with Infants and its Effectiveness in a Randomized Controlled Trial
Scientific Title:Acronym
The Effectiveness of a Disaster Prevention Educational Program for Mothers with Infants
Region
| Japan |
Condition
Condition
Mothers who have their infants for the first time
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of an educational program for midwives to provide earthquake preparedness support to mothers with their infants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome
(measured before, immediately after,
Two weeks and one month after the intervention)
1.Action of earthquake preparedness
Key secondary outcomes
Secondary outcome
(measured before, immediately after,
Two weeks and one month after the intervention)
1.Knowledge of earthquake preparedness
2.Perceptions of earthquake preparedness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: provide the as follows:ing
1.Education program (80-minute workshop)
2.A booklet for self-study
Interventions/Control_2
Control group: not provided
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
1. raise a child for the first time
2. an infant up to 11 months old
3. live in the 23 wards in Tokyo
4. Nuclear family household
5. Have an ability to answer the questionnai
re written in Japanese
6. Have a stable network connection for onli
ne participation
Key exclusion criteria
1.Those who engaged in disaster-related acti
vities (Firefighters, police officers, sel
f-defense personnel, medical personnel, an
d others)
2.Those who engaged in childcare-related act
ivities
3.multiple children
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Yamamoto |
Organization
Japanese Red Cross College of Nursing
Division name
Nursing Science
Zip code
150-0012
Address
4-1-3 Hiroo, Shibuya-ku, Tokyo, Japan
TEL
03-3409-0875
219D110@redcross.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Yamamoto |
Organization
Japanese Red Cross College of Nursing, Postgraduate School
Division name
Nursing Science
Zip code
150-0012
Address
4-1-3 Hiroo, Shibuya-ku, Tokyo, Japan
TEL
03-3409-0875
Homepage URL
219D110@redcross.ac.jp
Sponsor or person
Institute
Japanese Red Cross College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Yamaji Fumiko Professional Nursing Education and Research Foundation
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
Japanese Red Cross College of Nursing
Address
4-1-3 Hiroo, Shibuya-ku, Tokyo, Japan
Tel
03-3409-0875
219D110@redcross.ac.jp
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
| 2023 | Year | 06 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055840
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
