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OPERA Database - Crohn's Protocol

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01720368
First received: October 31, 2012
Last updated: November 1, 2012
Last verified: October 2012
History of Changes
  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:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

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

Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720368

Locations
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
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: November 1, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013