IBD-OPERA Database, UC Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01708395
First received: October 15, 2012
Last updated: May 5, 2014
Last verified: May 2014

October 15, 2012
May 5, 2014
October 2012
March 2015   (final data collection date for primary outcome measure)
Validity of patient self reporting [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The validity of patient self report on details of their ulcerative colitis compared to chart review. Validity is defined as a match between patient self report and medical records.
Not Provided
Complete list of historical versions of study NCT01708395 on ClinicalTrials.gov Archive Site
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IBD-OPERA Database, UC Protocol
IBD-OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database

The investigators believe that patients with ulcerative colitis are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.

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Observational
Time Perspective: Prospective
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Probability Sample

Adults over 18 years of age

Inflammatory Bowel Disease
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  • Cohort 1
    First 50 patients
  • Cohort 2
    2nd group of 50 patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • MD documented diagnosis of ulcerative colitis
  • current of past prescription for anti-TNF medication
  • at least 18 years of age
  • access to medical records to verify information
  • 20% of participants will be patients diagnosed within 1 year of inclusion

Exclusion Criteria:

  • unwilling or unable to provide informed consent for study participation
  • unable to access or use internet
  • less than 18 years of age
  • diagnosis of crohn's disease or IBD-U
  • illiterate or does not possess minimum level of literacy required to complete questionnaire
Both
18 Years and older
No
Contact: Jennifer Greene, RN jennifer.greene@bridgeibd.com
Contact: Corey Siegel, MD 603-650-8101 corey.a.siegel@hitchcock.org
United States
 
NCT01708395
REMICADEIBD4007
No
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Janssen Services, LLC
Not Provided
Dartmouth-Hitchcock Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP