UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040539 |
|---|---|
| Receipt number | 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 | 2020/11/26 09:07:46 |
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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
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
kii.gast@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
| 2020 | Year | 05 | Month | 26 | Day |
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 | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046274
