UMIN-CTR Clinical Trial

Basic information
Public title	Development and evaluation of an English learning system using smartphones in Japanese dental hygiene education
Acronym	Development and evaluation of an English learning system using smartphones in Japanese dental hygiene education
Scientific Title	Development and evaluation of an English learning system using smartphones in Japanese dental hygiene education
Scientific Title:Acronym	Development and evaluation of an English learning system using smartphones in Japanese dental hygiene education
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarify educational effects of learning English with smartphones in dental hygiene students.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of examination scores between control and intervention groups
Key secondary outcomes	Results of questionnaire, learners' academic performance, and learning history

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Participants in group I, control group, will take examinations twice with an interval which equals to intervention group's learning period. Then, they will learn English using smartphones at the same time as the intervention group will do.
Interventions/Control_2	Participants in group II, intervention group, will take examinations before and after learning English using smartphones.
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	Students and faculties of educational or medical institutes who learned English with smartphones, and those who agree with this study
Key exclusion criteria	Those who didn't agree with the study
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Atsuhiro Middle name Last name Kinoshita
Organization	Tokyo Medical and Dental University (TMDU)
Division name	Department of Educational Media Development
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-4643
Email	kinoshita.emdv@tmd.ac.jp

Public contact
Name of contact person	1st name Akane Middle name Last name Takenouchi
Organization	Shinjuku Medical Career College
Division name	Dental Hygiene Course
Zip code	160-0017
Address	5, Samon-cho, Shinju-ku, Tokyo, Japan
TEL	03-3352-6811
Homepage URL
Email	ssjs.takenouchi@gmail.com

Sponsor
Institute	Tokyo Medical and Dental University (TMDU)
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University (TMDU)
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	Taiyo School of Dental Hygiene
Address	2-22-1, Nishi-nippori, Arakawa-ku, Tokyo, Japan
Tel	03-5810-8020
Email	matukubo@tdc.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	2018 Year 04 Month 16 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	Completed
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 04 Month 18 Day
Anticipated trial start date	2018 Year 04 Month 18 Day
Last follow-up date	2020 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	2018 Year 04 Month 16 Day
Last modified on	2021 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036790