IBD-OPERA Database, UC Protocol

This study is currently recruiting participants.
Verified October 2013 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01708395
First received: October 15, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: IBD-OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Validity of patient self reporting [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort 1
First 50 patients
Cohort 2
2nd group of 50 patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adults over 18 years of age

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708395

Contacts
Contact: Jennifer Greene, RN jennifer.greene@bridgeibd.com
Contact: Corey Siegel, MD 603-650-8101 corey.a.siegel@hitchcock.org

Locations
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Corey A Siegel, MD    603-650-4481    corey.a.siegel@hitchcock.org   
Contact: Jennifer A Greene, RN    434-982-0709    jennifer.greene@bridgeibd.com   
Principal Investigator: Corey A Siegel, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Janssen Services, LLC
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01708395     History of Changes
Other Study ID Numbers: REMICADEIBD4007
Study First Received: October 15, 2012
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Ulcerative colitis

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 23, 2014