UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061319 |
|---|---|
| Receipt number | R000070159 |
| Scientific Title | Development of coordination between hospitals and clinics using an IBD app monitoring symptom of IBD patients. |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/20 12:26:18 |
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Basic information
Public title
Development of coordination between hospitals and clinics using an IBD app monitoring symptom of IBD patients.
Acronym
IBD app
Scientific Title
Development of coordination between hospitals and clinics using an IBD app monitoring symptom of IBD patients.
Scientific Title:Acronym
IBD app
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this newly developed IBD app is to establish a system whereby patients can record their symptoms daily-such as the number of bowel movements and the frequency of bloody stools-and doctors can monitor this information. Furthermore, the aim is to establish a system of inter-hospital collaboration whereby IBD specialists at specialist hospitals can monitor patients currently receiving treatment at other hospitals and provide this information to their attending doctors.
Basic objectives2
Others
Basic objectives -Others
Demonstrate the convenience offered by the app.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
None
Key secondary outcomes
Frequency of IBD app malfunctions, frequency of patient data entry into the IBD app, burden on doctors in monitoring patients, frequency of detecting disease flare-ups, number of unscheduled visits, and development of a flare-up prediction algorithm
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients currently receiving treatment at the University of Tsukuba Hospital or the Tsukuba Gastroenterology and Endoscopy Clinic
2. Patients diagnosed with ulcerative colitis
3. Patients aged 18 or over
4. Patients who are able to install the IBD app on a smart device
Key exclusion criteria
those deemed inappropriate by the researchers
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kiichiro |
| Middle name | |
| Last name | Tsuchiya |
Organization
University of Tsukuba Hospital
Division name
Gastroenterology
Zip code
305-8575
Address
1-1-1, Tennodai, Tsukuba city, Ibaraki
TEL
029-853-3218
kii.gast@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kiichiro |
| Middle name | |
| Last name | Tsuchiya |
Organization
University of Tsukuba Hospital
Division name
Gastroenterology
Zip code
305-8575
Address
1-1-1, Tennodai, Tsukuba city, Ibaraki
TEL
029-853-3218
Homepage URL
kii.gast@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Plusmedi Corp.
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
Ethical Committee, University of Tsukuba Hospital
Address
2-1-1, Amakubo, Tsukuba city, Ibaraki
Tel
029-853-3914
rinshokenkyu@un.tsukuba.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
| 2026 | Year | 04 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070159
