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OPERA Database - Crohn's Protocol (OPERA)

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. Read our disclaimer for details. Identifier: NCT01720368
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : August 17, 2015
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:
The investigators believe that patients with Crohn's disease 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.

Condition or disease
Inflammatory Bowel Disease Crohn's Disease

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Study Type : Observational
Actual Enrollment : 50 participants
Time Perspective: Prospective
Official Title: IBD-OPERA Database IBD OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database - Crohn's Protocol
Study Start Date : October 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

1st Group of 50 patients
2nd Group of 50 patients

Primary Outcome Measures :
  1. Validity of patient self reporting [ Time Frame: 12 months ]
    The validity of patient self report on details of their Crohn's disease compared to chart review. Validity is defined as a match between patient self report and medical records.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men and women over 18 years of age with Crohn's disease

Inclusion Criteria:

  • Adults (over 18 years of age) with physician diagnosed Crohn's disease
  • A current or past prescription of anti-TNF
  • Access to medical record for validation of clinical information

Exclusion Criteria:

  • Unwilling or unable to provide informed consent for study participation
  • Unable to access or use the internet
  • Ulcerative colitis or IBD-U
  • Illiterate or does not possess minimum level of literacy required to complete questionnaire

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 identifier (NCT number): NCT01720368

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United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center

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Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT01720368     History of Changes
Other Study ID Numbers: IMM 10-0162
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Keywords provided by Dartmouth-Hitchcock Medical Center:
Additional relevant MeSH terms:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases