OPERA Database - Crohn's Protocol (OPERA)

August 14, 2015 updated by: Dartmouth-Hitchcock Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1st Group of 50 patients
2nd Group of 50 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of patient self reporting
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 1, 2012

First Posted (Estimate)

November 2, 2012

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMM 10-0162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe