IBD-OPERA Database, UC Protocol

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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Key information

Conditions

Inflammatory Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

Janssen Services, LLC

Registry information

Official study title

IBD-OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database

Acronym: OPERA

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Oct 17, 2012
Registry last updated: Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed