UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034728 |
|---|---|
| Receipt number | R000039589 |
| Scientific Title | Clinical research for assessment of utility and development of outpatient AI interview system |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2022/05/05 22:26:42 |
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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
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
shun081359@gmail.com
Sponsor or person
Institute
Division of Rheumatology, Department of Internal Medicine,Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039589
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
