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NCT01708395 Clinical Trial

IBD-OPERA Database, UC Protocol

Inflammatory Bowel Disease Clinical Trial

— OPERA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01708395
Other study ID # REMICADEIBD4007
Secondary ID
Status Completed
Phase N/A
First received October 15, 2012
Last updated August 14, 2015
Start date October 2012
Est. completion date June 2015

Study information
Verified date August 2015
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire

Sponsors (2)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center Janssen Services, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validity of patient self reporting 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. 12 months No
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