ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02760836
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Eun Soo Kim, MD, PhD, Kyungpook National University

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
Crohn's Disease

Study Type : Observational
Estimated 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
Study Start Date : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease




Primary Outcome Measures :
  1. Hospitalization [ Time Frame: 2 years ]
  2. Unscheduled visit [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Bowel resection surgery [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Crohn's disease from 4 tertiary referral centers.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760836


Contacts
Contact: Eun Soo Kim, MD, PhD +82-53-200-5879 dandy813@hanmail.net

Locations
Korea, Republic of
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 41944
Contact: Eun Soo Kim, MD, PhD       dandy813@hanmail.net   
Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: Eun Soo Kim, MD, PhD Kyungpook National University

Responsible Party: Eun Soo Kim, MD, PhD, Professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT02760836     History of Changes
Other Study ID Numbers: KNUH2016-03-030
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eun Soo Kim, MD, PhD, Kyungpook National University:
Crohn's disease
disease outcomes

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases