<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01708395</url>
  </required_header>
  <id_info>
    <org_study_id>REMICADEIBD4007</org_study_id>
    <nct_id>NCT01708395</nct_id>
  </id_info>
  <brief_title>IBD-OPERA Database, UC Protocol</brief_title>
  <acronym>OPERA</acronym>
  <official_title>IBD-OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Services, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators believe that patients with ulcerative colitis are able to report details of&#xD;
      their own medical history accurately and record changes in clinical status effectively over&#xD;
      time. Using an internet-based database the investigators will ask patients to report their&#xD;
      own disease history, and the investigators will compare their reports to the medical record.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validity of patient self reporting</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>First 50 patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>2nd group of 50 patients</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults over 18 years of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MD documented diagnosis of ulcerative colitis&#xD;
&#xD;
          -  current of past prescription for anti-TNF medication&#xD;
&#xD;
          -  at least 18 years of age&#xD;
&#xD;
          -  access to medical records to verify information&#xD;
&#xD;
          -  20% of participants will be patients diagnosed within 1 year of inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unwilling or unable to provide informed consent for study participation&#xD;
&#xD;
          -  unable to access or use internet&#xD;
&#xD;
          -  less than 18 years of age&#xD;
&#xD;
          -  diagnosis of crohn's disease or IBD-U&#xD;
&#xD;
          -  illiterate or does not possess minimum level of literacy required to complete&#xD;
             questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>August 14, 2015</last_update_submitted>
  <last_update_submitted_qc>August 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ulcerative colitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01708395
org study id: REMICADEIBD4007
nct id: NCT01708395
lead sponsor: 
collaborator: 
has dmc: No
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.
time perspective: Prospective
measure: Validity of patient self reporting
time frame: 12 months
description: 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.
arm group label: Cohort 1
description: First 50 patients
arm group label: Cohort 2
description: 2nd group of 50 patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases