UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036673 |
|---|---|
| Receipt number | R000041786 |
| Scientific Title | Study on the medical support using smart device for the patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2020/05/08 09:09:53 |
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Basic information
Public title
Study on the medical support using smart device for the patients with inflammatory bowel disease
Acronym
Study on medical support using smart device for the patients with IBD
Scientific Title
Study on the medical support using smart device for the patients with inflammatory bowel disease
Scientific Title:Acronym
Study on medical support using smart device for the patients with IBD
Region
| Japan |
Condition
Condition
Inflammatory Bowel Disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is the establishment of the system for medical support using smart devise from specialized doctors when the patients with Inflammatory Bowel Disease attend general hospital and clinic, regularly.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease severity
Key secondary outcomes
The rate for going to general hospital and clinic.
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 mild severity IBD
( Partial Mayo Score < 2 )
Key exclusion criteria
The patients with the treatment of biologic drugs
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kiichiro |
| Middle name | |
| Last name | Tsuchiya |
Organization
Tokyo Medical and Dental University
Division name
Medical Hospital, 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
Medical Hospital, 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
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5974
kii.gast@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
| 2019 | Year | 06 | 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
15
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2019 | Year | 05 | Month | 08 | Day |
Last modified on
| 2020 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041786
