UMIN-CTR Clinical Trial

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
Email	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
Email	kobataku@insti.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University Kitasato Institute Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045439