UMIN-CTR Clinical Trial

Basic information
Public title	Can humanoid robot EMIEW be effective support system for medical staffs? : a prospective controlled study
Acronym	Can humanoid robot EMIEW be effective support system for medical staffs? : a prospective controlled study
Scientific Title	Can humanoid robot EMIEW be effective support system for medical staffs? : a prospective controlled study
Scientific Title:Acronym	Can humanoid robot EMIEW be effective support system for medical staffs? : a prospective controlled study
Region	Japan

Condition
Condition	non
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate duty reduction effect for medical workers by using humanoid robot "EMIEW3"
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in Patient Response Time for Admission/Discharge Explanation with or without Support by EMIEW 3
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	Humanoid robot EMIES3 does the routine explanation instead of medical worker.
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Persons who obtain written consent to participate in the study.
Key exclusion criteria	Persons for whom it is difficult to confirm their intention. More than one person to explain. Persons whose research director has determined that inclusion in research is inappropriate.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tokuhara Middle name Last name Makoto
Organization	National Center for Global Health and Medicine
Division name	Admission support center
Zip code	162-8655
Address	1-21-1 Toyama Shinjuku-ku Tokyo
TEL	03-3202-7181
Email	mtokuha@hosp.ncgm.go.jp

Public contact
Name of contact person	1st name Tokuhara Middle name Last name Makoto
Organization	National Center for Global Health and Medicine
Division name	Admission support center
Zip code	162-8655
Address	1-21-1 Toyama Shinjuku-ku Tokyo
TEL	03-3202-7181
Homepage URL
Email	mtokuha@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	HITACHI Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Center for Global Health and Medicine
Address	1-21-1 Toyama Shinjuku-ku Tokyo
Tel	03-3202-7181
Email	rinrijm@hosp.ncgm.go.jp/ rinrijm@hosp.ncgm.go.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCGM-G-003095-01
Org. issuing International ID_1	National Center for Global Health and Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立国際医療研究センター

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 01 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	2019 Year 03 Month 19 Day
Date of IRB	2019 Year 04 Month 05 Day
Anticipated trial start date	2019 Year 05 Month 13 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 07 Day

Other
Other related information

Management information
Registered date	2019 Year 04 Month 30 Day
Last modified on	2021 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041726