OPERA Database - Crohn's Protocol

Completed

• Conditions: Crohn's Disease; Inflammatory Bowel Disease

• Registration Number: NCT01720368
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-02
• Primary Completion: 2015-03
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validity of patient self reporting	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.

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States