- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02760836
Predictive Model of Clinical Outcomes Using Web-based Self-reporting Symptom Diary for Crohn's Disease (PICASSO)
August 12, 2019 updated by: Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
Development and Validation of Predictive Model of Clinical Outcomes Using Pattern Analysis of Web-based Self-reporting Symptom Diary for Crohn's Disease
The purpose of this study is to develop and validate a predictive model of clinical outcomes based on the results of web-based self-reporting symptom diary for Crohn's disease.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eun Soo Kim, MD, PhD
- Phone Number: +82-53-200-5879
- Email: dandy813@hanmail.net
Study Locations
-
-
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Daegu, Korea, Republic of, 41944
- Recruiting
- Kyungpook National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Crohn's disease from 4 tertiary referral centers.
Description
Inclusion Criteria:
- Newly diagnosed of Crohn's disease within 6 months
- Must record their symptom in a web-based symptom diary at least 4 consecutive times for 2 months.
Exclusion Criteria:
- Not able to use smart phone.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospitalization
Time Frame: 2 years
|
2 years
|
Unscheduled visit
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bowel resection surgery
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Anticipated)
April 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
May 2, 2016
First Submitted That Met QC Criteria
May 3, 2016
First Posted (Estimate)
May 4, 2016
Study Record Updates
Last Update Posted (Actual)
August 13, 2019
Last Update Submitted That Met QC Criteria
August 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KNUH2016-03-030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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