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IBD-OPERA Database, UC Protocol (OPERA)

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ClinicalTrials.gov Identifier: NCT01708395
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : August 17, 2015
Janssen Services, LLC
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

October 15, 2012
October 17, 2012
August 17, 2015
October 2012
March 2015   (Final data collection date for primary outcome measure)
Validity of patient self reporting [ Time Frame: 12 months ]
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.
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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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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.
June 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Janssen Services, LLC
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Dartmouth-Hitchcock Medical Center
August 2015