UMIN-CTR Clinical Trial

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
Email	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
Email	ykakuta@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054140