UMIN-CTR Clinical Trial

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	https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-10627-w
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	1062
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	CSQ-8
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 12 Month 15 Day
Date of IRB	2020 Year 02 Month 23 Day
Anticipated trial start date	2021 Year 03 Month 15 Day
Last follow-up date	2021 Year 03 Month 17 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2021 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 11 Month 17 Day
Last modified on	2021 Year 05 Month 19 Day

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