UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research for assessment of utility and development of outpatient AI interview system
Acronym	Clinical research for assessment of utility of outpatient AI interview system
Scientific Title	Clinical research for assessment of utility and development of outpatient AI interview system
Scientific Title:Acronym	Clinical research for assessment of utility of outpatient AI interview system
Region	Japan

Condition
Condition	Outclinic patient
Classification by specialty	Clinical immunology Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the usefulness and problems of the AI interview system in clinical practice and to further reflect these assessment and develop the system.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Satisfaction level for interview among doctors and patients
Key secondary outcomes	Time for patient examination

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Prior interview with conventional paper interview card
Interventions/Control_2	Prior interview with AI interview system
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	In cases where informed consent can be acquired from the principal or substitute of patients, at the visits of outpatient clinic
Key exclusion criteria	Patients who can not obtain informed consent to participate in the study
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Kaneko
Organization	Department of Internal Medicine, Keio University School of Medicine
Division name	Division of Rheumatology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3786
Email	ykaneko.z6@keio.jp

Public contact
Name of contact person	1st name Shuntaro Middle name Last name Saito
Organization	Department of Internal Medicine, Keio University School of Medicine
Division name	Division of Rheumatology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3786
Homepage URL
Email	shun081359@gmail.com

Sponsor
Institute	Division of Rheumatology, Department of Internal Medicine,Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
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	IRB of Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel	0333531211
Email	med-rinri-jimu@adst.keio.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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	439
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	Main results already published
Date of protocol fixation	2018 Year 11 Month 02 Day
Date of IRB	2019 Year 02 Month 25 Day
Anticipated trial start date	2019 Year 02 Month 28 Day
Last follow-up date	2022 Year 04 Month 13 Day
Date of closure to data entry	2022 Year 04 Month 13 Day
Date trial data considered complete	2022 Year 04 Month 13 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 31 Day
Last modified on	2022 Year 05 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039589