UMIN-CTR Clinical Trial

Basic information
Public title	Impact of using ICT for learning English in the elementary education.
Acronym	Impact of using ICT for learning English in the elementary education.
Scientific Title	Impact of using ICT for learning English in the elementary education.
Scientific Title:Acronym	Impact of using ICT for learning English in the elementary education.
Region	Japan

Condition
Condition	Education
Classification by specialty	Not applicable Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify how effective using tablet devices for English learning in the early elementary education.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Increase in test scores after the intervention
Key secondary outcomes	Increase in satisfaction scores after the intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Educational program using tablet device and application.
Interventions/Control_2	Educational program using tablet device without application.
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	6 years-old <=
Age-upper limit	8 years-old >=
Gender	Male and Female
Key inclusion criteria	Lower elementary students who are independent using tablet device and agree with this program.
Key exclusion criteria	Lower elementary students who are not independent using tablet device.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name FUJII
Organization	Osaka university
Division name	Division of Health Science, Graduate school of medicine
Zip code	5650871
Address	1-7 Yamadaoka, Suita
TEL	0668792614
Email	m.fujii@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Rikito Middle name Last name HORI
Organization	Kansai university
Division name	Elementary school
Zip code	569-1098
Address	1-7 Hakubaicho, Takatsuki
TEL	072-684-4000
Homepage URL
Email	r.hori@kansai-u.ac.jp

Sponsor
Institute	Kansai university
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka university
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kansai university
Address	3-3-35, Yamatecho, Suita
Tel	06-6368-1784
Email	kenken@jm.kansai-u.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	2021 Year 02 Month 08 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	No longer recruiting
Date of protocol fixation	2020 Year 11 Month 01 Day
Date of IRB	2021 Year 01 Month 25 Day
Anticipated trial start date	2021 Year 02 Month 19 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 04 Month 01 Day
Date trial data considered complete	2021 Year 04 Month 30 Day
Date analysis concluded	2022 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2021 Year 01 Month 16 Day
Last modified on	2022 Year 02 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049122