- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01708395
IBD-OPERA Database, UC Protocol (OPERA)
August 14, 2015 updated by: Dartmouth-Hitchcock Medical Center
IBD-OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database
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.
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
-
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New Hampshire
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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
Adults over 18 years of age
Description
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 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 |
---|
Cohort 1
First 50 patients
|
Cohort 2
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 ulcerative colitis 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.
Collaborators
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 15, 2012
First Submitted That Met QC Criteria
October 16, 2012
First Posted (Estimate)
October 17, 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
- REMICADEIBD4007
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.
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