UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047474 |
|---|---|
| Receipt number | R000054140 |
| Scientific Title | Building a platform for surveying and sharing information on patients with inflammatory bowel disease using social network services. |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/06/17 15:12:21 |
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Basic information
Public title
Building a platform for surveying and sharing information on patients with inflammatory bowel disease using social network services.
Acronym
IBD-LINQ
Scientific Title
Building a platform for surveying and sharing information on patients with inflammatory bowel disease using social network services.
Scientific Title:Acronym
IBD-LINQ
Region
| Japan |
Condition
Condition
Inflammatory bowel disease, Crohn's disease, ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will construct a platform for conducting disease condition and awareness surveys of patients with inflammatory bowel disease using social network services on smartphones and other devices owned by the patients, and examine the usefulness and problems of using this platform as a tool for interactive patient care and research.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Annual change in response rate for regular survey questionnaires
Response rates and trends for irregular surveys
Key secondary outcomes
Enrollment rate in the system among patients attending an outpatient clinic for the disease in question
Differences in response rates between anonymized and linkable anonymized questionnaires
Differences in response rates between surveys that generate rewards and those that do not
Comparison of all of the above by disease, gender, and age group
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
Diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis, intestinal Behcet's disease, etc.)
The individual is using the LINE service operated by LINE Corporation on his/her mobile device.
Key exclusion criteria
(1) Those who have difficulty using the LINE service
(2) Others whom the attending physician deems inappropriate
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Kakuta |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo Aoba, Sendai
TEL
0227177171
ykakuta@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Kakuta |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo Aoba, Sendai
TEL
0227177171
Homepage URL
ykakuta@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo Aoba, Sendai
Tel
022-728-4105
med-kenkyo@grp.tohoku.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
| 2022 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will conduct a regular questionnaire twice a year and a brief questionnaire on an irregular basis.
Management information
Registered date
| 2022 | Year | 04 | Month | 12 | Day |
Last modified on
| 2022 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054140
