OPERA Database - Crohn's Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01720368
First received: October 31, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition
Inflammatory Bowel Disease
Crohn's Disease

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

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 Crohn's disease 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 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
1st Group of 50 patients
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

Men and women over 18 years of age with Crohn's disease

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720368

Contacts
Contact: Jennifer A Greene, RN jennifer.greene@bridgeibd.com
Contact: Corey A 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 Siegel, MD    603-650-4481    corey.a.siegel@hitchcock.org   
Contact: Jennifer Greene, RN    4349820709    jennifer.greene@bridgeibd.com   
Principal Investigator: Corey A Siegel, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Abbott
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01720368     History of Changes
Other Study ID Numbers: IMM 10-0162
Study First Received: October 31, 2012
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
IBD
Crohn's

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

ClinicalTrials.gov processed this record on October 01, 2014