UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039842 |
|---|---|
| Receipt number | R000045439 |
| Scientific Title | Feasibility study of disease management application for patients with ulcerative colitis |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/03/18 09:33:24 |
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Basic information
Public title
Feasibility study of disease management application for patients with ulcerative colitis
Acronym
Feasibility study of disease management application for patients with ulcerative colitis
Scientific Title
Feasibility study of disease management application for patients with ulcerative colitis
Scientific Title:Acronym
Feasibility study of disease management application for patients with ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the acceptability and feasibility of disease management application for patients with ulcerative colitis
Basic objectives2
Others
Basic objectives -Others
Feasibility of disease management application
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction to applications by users (patients and healthcare professionals) at week 12
Key secondary outcomes
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
1. Confirmed with diagnosis of ulcerative colitis based on the diagnosis/treatment guideline by specific disease investigation committee of Japanese ministry of health, labor and welfare ,ver. March,2019
2. Capable of using smartphones
Key exclusion criteria
1. Unable to gain informed consent by documents
2. Unable to understand Japanese
3. Participating in other interventional trials
4. Regarded as not appropriate candidate for this research by physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo, Japan
TEL
03-3444-6161
kobataku@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo, Japan
TEL
03-3444-6161
Homepage URL
kobataku@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Activaid Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Kitasato Institute Hospital
Address
5-9-1, Shirokane, Minato-ku, Tokyo, Japan
Tel
03-3444-6161
kenkyu@insti.kitasato-u.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 | 04 | 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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcome measure: Satisfaction to applications by users (patients and healthcare professionals) at week 12
Management information
Registered date
| 2020 | Year | 03 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045439
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
