UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056787 |
|---|---|
| Receipt number | R000064908 |
| Scientific Title | Research on the nature of tuberculosis instruction for Nepalese migrants to Japan: development of appropriate instructional materials for foreigners staying in Japan |
| Date of disclosure of the study information | 2025/01/22 |
| Last modified on | 2025/01/22 15:22:41 |
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Basic information
Public title
Research on the nature of tuberculosis instruction for Nepalese migrants to Japan: development of appropriate instructional materials for foreigners staying in Japan
Acronym
Development of TB education materials for Nepalese in Japan.
Scientific Title
Research on the nature of tuberculosis instruction for Nepalese migrants to Japan: development of appropriate instructional materials for foreigners staying in Japan
Scientific Title:Acronym
Development of TB education materials for Nepalese in Japan
Region
| Japan |
Condition
Condition
Tuberculosis
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of TB teaching materials developed for people of foreign origin who have stayed or are planning to stay in Japan for a medium to long period of time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference between the results of pre test and post test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Epidemiology of tuberculosis, information on diagnosis and treatment of tuberculosis in Japan.
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Nepalese nationals who are in Japan for the purpose of employment, study, study, etc.
Key exclusion criteria
None
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | MIKA |
| Middle name | |
| Last name | KIGAWA |
Organization
Kanagawa University of Human Services
Division name
Department of Liveral Arts and Scieences
Zip code
238-8522
Address
1-10-1 Heisei cho, Yokosuka city, Kanagawa Pref., Japan
TEL
046-828-2752
kigawa-c5s@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Kigawa |
Organization
Kanagawa University of Human Services
Division name
Department of Liveral Arts and Scieences
Zip code
238-8522
Address
1-10-1 Heisei cho, Yokosuka city, Kanagawa Pref., Japan
TEL
046-828-2752
Homepage URL
kigawa-c5s@kuhs.ac.jp
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Kanagawa University of Human Services
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
Research Ethics Inquiry Service of Kanagawa University of Human Services
Address
1-10-1 Heisei cho, Yokosuka city, Kanagawa Pref., Japan
Tel
046-828-2530
kenkyuurinri@kuhs.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
| 2025 | Year | 01 | Month | 22 | 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
| 2024 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 01 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064908
