UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053160 |
|---|---|
| Receipt number | R000060667 |
| Scientific Title | Development of educational intervention materials for peer counsellors providing preconception care |
| Date of disclosure of the study information | 2024/01/25 |
| Last modified on | 2023/12/19 15:52:12 |
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Basic information
Public title
Development of educational intervention materials for peer counsellors providing preconception care
Acronym
Development of educational intervention materials for peer counsellors providing preconception care
Scientific Title
Development of educational intervention materials for peer counsellors providing preconception care
Scientific Title:Acronym
Development of educational intervention materials for peer counsellors providing preconception care
Region
| Japan |
Condition
Condition
(Healthy people)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to develop educational materials for peer educators who provide peer counselling on preconception care to adolescents and young adults, this study aims to identify the acceptability, practicality and demands of the materials by interviewing women in their early 20s who are potential peer counsellors.
Basic objectives2
Others
Basic objectives -Others
In order to develop educational materials for peer educators who provide peer counselling on preconception care to adolescents and young adults, this study aims to identify the acceptability, practicality and demands of the materials by interviewing women in their early 20s who are potential peer counsellors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Focuses in materials for peer counsellors providing preconception care and the acceptability, practicality and demand for the materials developed.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
1. women aged between 20 and 25 years
2. nursing students or postgraduate nursing students
3. who are interested in preconception care
4. who are able to participate in the focus group interview after watching the video beforehand
Key exclusion criteria
There is no exclusion criteria
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Suzuki |
Organization
National Center for Child Health and Development
Division name
Perinatal and Maternity care center
Zip code
157-8535
Address
2-10-1 Ookura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
suzuki-hi@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Suzuki |
Organization
National Center for Child Health and Development
Division name
Perinatal and Maternity care center
Zip code
157-8535
Address
2-10-1 Ookura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
Homepage URL
suzuki-hi@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Developmnet
Address
2-10-1 Ookura, Setagaya-ku, Tokyo, Japan
Tel
03-3416-0181
suzuki-hi@ncchd.go.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
| 2024 | Year | 01 | Month | 25 | 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
| 2024 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 25 | 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
No data
Management information
Registered date
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060667
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
