OPERA Database - Crohn's Protocol

Dartmouth Health

Status: Completed

Conditions: Inflammatory Bowel Disease; Crohn's Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01720368

IMM 10-0162

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

1st Group of 50 patients

2nd Group of 50 patients