OPERA Database - Crohn's Protocol

IBD-OPERA Database IBD OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database - Crohn's Protocol

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01720368

Acronym

OPERA

Enrollment

Registered

2012-11-02

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

Crohn's Disease, Inflammatory Bowel Disease

Keywords

IBD, Crohn's

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results