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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040539
Receipt No. R000046274
Scientific Title Study for medical support using smart devise for IBD patients under the novel coronavirus prevalence.
Date of disclosure of the study information 2020/07/01
Last modified on 2020/05/27

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Basic information
Public title Study for medical support using smart devise for IBD patients under the novel coronavirus prevalence.
Acronym Medical support using IBD app
Scientific Title Study for medical support using smart devise for IBD patients under the novel coronavirus prevalence.
Scientific Title:Acronym Medical support using IBD app
Region
Japan

Condition
Condition Inflammatory Bowel Disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is difficult for the patients to come hospital under the novel coronavirus prevalence. We aim to evaluate the utility of smart device, which the patients are able to input their symptoms every day. Moreover, the doctors are also able to check clinical state of each IBD patients.
Basic objectives2 Others
Basic objectives -Others benefit of smart device for the patients with IBD
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Utilization rate of smart device after 24 weeks
Key secondary outcomes Clinical state of the patients

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria The patients with Ulcerative Colitis who attend our hospital.
Key exclusion criteria under 19 years old
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Kiichiro
Middle name
Last name Tsuchiya
Organization Tokyo Medical and Dental University
Division name Gastroenterology and Hepatology
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5974
Email kii.gast@tmd.ac.jp

Public contact
Name of contact person
1st name Kiichiro
Middle name
Last name Tsuchiya
Organization Tokyo Medical and Dental University
Division name Gastroenterology and Hepatology
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5974
Homepage URL
Email kii.gast@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Hitachi, Ltd.
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 Tokyo Medical and Dental University ethics committee
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-5096
Email info.bec@tmd.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
2020 Year 07 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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 05 Month 27 Day
Last modified on
2020 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046274

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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