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PICASSO: Predictive Model of Clinical Outcomes Using Web-based Self-reporting Symptom Diary for Crohn's Disease

Sponsor
Kyungpook National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02760836
Collaborator
(none)
250
Enrollment
1
Location
56
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Development and Validation of Predictive Model of Clinical Outcomes Using Pattern Analysis of Web-based Self-reporting Symptom Diary for Crohn's Disease
    Actual Study Start Date :
    Apr 1, 2016
    Anticipated Primary Completion Date :
    Apr 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Hospitalization [2 years]

    2. Unscheduled visit [2 years]

    Secondary Outcome Measures

    1. Bowel resection surgery [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kyungpook National University Hospital Daegu Korea, Republic of 41944

    Sponsors and Collaborators

    • Kyungpook National University Hospital

    Investigators

    • Principal Investigator: Eun Soo Kim, MD, PhD, Kyungpook National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eun Soo Kim, MD, PhD, Professor, Kyungpook National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02760836
    Other Study ID Numbers:
    • KNUH2016-03-030
    First Posted:
    May 4, 2016
    Last Update Posted:
    Aug 13, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Eun Soo Kim, MD, PhD, Professor, Kyungpook National University Hospital
    Crohn's disease
    disease outcomes
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of Aug 13, 2019