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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042483
Receipt No. R000048075
Scientific Title Japanese health and safety information for international visitors: a randomized controlled trial
Date of disclosure of the study information 2020/11/17
Last modified on 2020/11/17

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Basic information
Public title Japanese health and safety information for international visitors: a randomized controlled trial
Acronym Japanese health and safety information for international visitors
Scientific Title Japanese health and safety information for international visitors: a randomized controlled trial
Scientific Title:Acronym Japanese health and safety information for international visitors: a randomized controlled trial
Region
North America Australia Europe

Condition
Condition Healthy people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The number of international visitors to Japan has steadily increased over the last decade until pandemic of COVID19. Providing health information for international visitors is important to reduce the risk of health problems and enjoy a comfortable stay. In this study, we are going to examine the effect of a five minutes digital game titled Sa Chan Game Japan on the level of satisfaction and motivation of an educational experience for international visitors to Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will conduct a randomized controlled trial (RCT). We will evaluate both the differences in satisfaction and motivation level before and after the intervention which is an animation titled
Sachan game, and between the intervention and control groups will watch a digital animation in English named Mari Info Japan. We will assess the outcome of satisfaction with the CSQ (Client Satisfaction Questionnaire)8.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 sa-chan game
Interventions/Control_2 Control: one time
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

Not applicable
Gender Male and Female
Key inclusion criteria People who have registered on the site via the web research company M Mechanical Turk and have visited Japan or would like to visit in the future.
Key exclusion criteria age>18
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Mariko
Middle name
Last name Nishikawa
Organization University of Human Environments
Division name Graduate School of Nursing
Zip code 474-0035
Address 3-220, Ebata-cho, Obu City, Aichi, Japan
TEL 0562-43-0701
Email mn378@nyu.edu

Public contact
Name of contact person
1st name Mariko
Middle name
Last name Nishikawa
Organization University of Human Environments
Division name Graduate School of Nursing
Zip code 474-0035
Address 3-220, Ebata cho, Obu City, Aichi, Japan
TEL 0562-43-0701
Homepage URL
Email mn378@nyu.edu

Sponsor
Institute University of Human Environments
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Community and Global Health, Graduate School of Medicine, the University of Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, Universit of Human Environments
Address 3-220, Ebata cho, Obu City, Aichi, Japan
Tel 0562-43-0701
Email t-inayoshi@uhe.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
2020 Year 11 Month 17 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
2020 Year 12 Month 15 Day
Date of IRB
2020 Year 02 Month 23 Day
Anticipated trial start date
2020 Year 12 Month 15 Day
Last follow-up date
2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 17 Day
Last modified on
2020 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048075

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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