IBD-OPERA Database, UC Protocol

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01708395

Acronym

OPERA

Enrollment

Registered

2012-10-17

Start date

2012-10-31

Completion date

2015-06-30

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

Ulcerative colitis

Brief summary

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Validity of patient self reporting	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.

Countries

United States

Outcome results