<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/NCT01692743</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00049230</org_study_id>
    <nct_id>NCT01692743</nct_id>
  </id_info>
  <brief_title>Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)</brief_title>
  <acronym>TELE-IBD</acronym>
  <official_title>Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Improved methods are needed to monitor patients with inflammatory bowel disease. Telemedicine&#xD;
      has shown promise in patients with other chronic diseases; pilot testing in our patients with&#xD;
      inflammatory bowel disease demonstrated that the technology was feasible and improved&#xD;
      clinical outcomes.&#xD;
&#xD;
      The telemedicine system for patients with inflammatory bowel disease (Tele-IBD) should&#xD;
      improve outcomes for patients, improve access to care in areas with limited resources, and&#xD;
      decrease health care costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Inflammatory bowel disease (IBD) is a chronic condition that results in&#xD;
      debilitating symptoms. Although effective treatments exist, inadequate monitoring of symptoms&#xD;
      and side effects, nonadherence, and poor patient knowledge are barriers to success.&#xD;
      Telemedicine has been used in other chronic diseases to improve outcomes; pilot testing of&#xD;
      telemedicine demonstrated that it is feasible and accepted in IBD. Our preliminary results&#xD;
      from a randomized trial in participants with ulcerative colitis showed significant&#xD;
      improvements in quality of life from baseline to one year in the telemanagement group.&#xD;
&#xD;
      Study Design: Telemedicine for Patients with Inflammatory Bowel Disease (Tele-IBD) is a&#xD;
      12-month, multicenter, randomized, controlled trial to assess the impact of Tele-IBD compared&#xD;
      to standard care in participants with IBD. The aims of the study are to: (1) assess disease&#xD;
      activity in participants with IBD using Tele-IBD compared to participants using standard&#xD;
      care, (2) assess quality of life in participants with IBD using Tele-IBD compared to&#xD;
      participants using standard care, and (3) estimate differences of person-level rates of&#xD;
      utilization of health care resources in participants with IBD using Tele-IBD compared to&#xD;
      participants using standard care.&#xD;
&#xD;
      Methods: Tele-IBD consists of a web-portal and a weight scale. Participants answer questions&#xD;
      about IBD symptoms, side effects and adherence using their home PC or a laptop with wireless&#xD;
      Internet access provided to them for the study. A series of educational topics is&#xD;
      administered via video messaging every 2-3 weeks. Tele-IBD participants complete self-testing&#xD;
      weekly or every other week; the results are immediately available on the web-portal for&#xD;
      review. Based on the responses, alerts and action plans are created for each participant. A&#xD;
      nurse care coordinator consults the participant's medical provider for management changes if&#xD;
      necessary. IBD patients evaluated at the University of Maryland, Baltimore, University of&#xD;
      Pittsburgh, and Vanderbilt University will be invited to participate. Interested patients&#xD;
      will be randomized in a 1:1:1 fashion to receive Tele-IBD weekly, Tele-IBD every other week,&#xD;
      or standard care. Disease activity, quality of life, medical adherence, and utilization of&#xD;
      health care resources will be assessed every 6 months for one year. In addition, provider&#xD;
      interactions with patients in all three arms will be monitored and recorded.&#xD;
&#xD;
      Expected Findings: Tele-IBD will decrease disease activity and improve quality of life&#xD;
      through improved adherence and monitoring of symptoms, earlier and more effective&#xD;
      implementation of therapy, more frequent patient-provider interactions, and improved patient&#xD;
      self-management. Better control of IBD will result in decreased utilization of health care&#xD;
      resources.&#xD;
&#xD;
      Significance: If Tele-IBD improves outcomes, it is likely to be used to improve IBD care, to&#xD;
      contain health care costs, to increase access to care, and to improve adherence with&#xD;
      physician performance measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Harvey Bradshaw Index</measure>
    <time_frame>12 months</time_frame>
    <description>Disease activity measure for patients with Crohn's disease. The activity index is comprised of 5 items. General well being (0-4), abdominal pain (0-3), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0-3), and complications (1 point per item). The total score is the sum of the individual parameters with scores less than 5 consistent with clinical remission. The minimum score is 0 and there is no pre-specified maximum score as it depends on the number of liquids stools.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammatory Bowel Disease Questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Description: A quality of life (QoL) questionnaire for patients with inflammatory bowel diseases [1].&#xD;
Format: 32 questions grouped into four dimensions: bowel, systemic, social, and emotional.&#xD;
Scoring: Scores for each question range from 1 (poorest QoL) to 7 (best QoL). The overall range for the 32 item questionnaire is 32-224 with higher scores indicate better QoL. Scores &gt;168 have been shown to correlate with clinical remission in patients with Crohn's disease and a change in score of 16-32 points is considered significant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health Care Utilization</measure>
    <time_frame>One year</time_frame>
    <description>Total healthcare encounters 1 year post randomization (a specific scale was not used, simple counts of all encounters after randomization were carried out)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">348</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <condition>Crohn's Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Indeterminate Colitis</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weekly Home Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home Monitoring Every Other Week</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home Monitoring</intervention_name>
    <description>Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
    <arm_group_label>Weekly Home Monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home Monitoring</intervention_name>
    <description>Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
    <arm_group_label>Home Monitoring Every Other Week</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of Crohn's disease, ulcerative colitis or indeterminate colitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot comprehend simple instructions in English&#xD;
&#xD;
          -  Inability to comply with the study protocol (i.e., active drug or alcohol abuse or&#xD;
             history of nonadherence to medical visits and/or medications)&#xD;
&#xD;
          -  Presence of an ileostomy, colostomy, ileoanal j pouch anastomosis or ileorectal&#xD;
             anastomosis&#xD;
&#xD;
          -  Imminent surgery&#xD;
&#xD;
          -  History of short bowel syndrome&#xD;
&#xD;
          -  No flares of disease in last two years&#xD;
&#xD;
          -  Uncontrolled medical or psychiatric disease Degenerative neurologic condition Unstable&#xD;
             angina Class III/IV congestive heart failure Severe asthma or chronic obstructive&#xD;
             pulmonary disease Symptomatic peripheral vascular disease Chronic renal insufficiency&#xD;
             (creatinine &gt; 2.0) Malignancy within the last 5 years (excluding squamous or basal&#xD;
             cell cancers of the skin) Poorly controlled depression, mania, and schizophrenia&#xD;
             Active infection Acquired immunodeficiency syndrome&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Age less than 18 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond K Cross, MD, MS, AGAF</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, College Park</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>October 3, 2017</results_first_submitted>
  <results_first_submitted_qc>April 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 17, 2019</results_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Raymond Cross</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Inflammatory bowel disease</keyword>
  <keyword>Crohn's disease</keyword>
  <keyword>Ulcerative colitis</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Health care utilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard of Care</title>
          <description>Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.</description>
        </group>
        <group group_id="P2">
          <title>Weekly Home Monitoring</title>
          <description>Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
        </group>
        <group group_id="P3">
          <title>Home Monitoring Every Other Week</title>
          <description>Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
                <participants group_id="P2" count="116"/>
                <participants group_id="P3" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="81"/>
                <participants group_id="P3" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard of Care</title>
          <description>Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.</description>
        </group>
        <group group_id="B2">
          <title>Weekly Home Monitoring</title>
          <description>Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
        </group>
        <group group_id="B3">
          <title>Home Monitoring Every Other Week</title>
          <description>Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="117"/>
            <count group_id="B2" value="116"/>
            <count group_id="B3" value="115"/>
            <count group_id="B4" value="348"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.1" spread="11.7"/>
                    <measurement group_id="B2" value="36.4" spread="11.5"/>
                    <measurement group_id="B3" value="40.1" spread="13.2"/>
                    <measurement group_id="B4" value="38.9" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="197"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="113"/>
                    <measurement group_id="B4" value="344"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="108"/>
                    <measurement group_id="B4" value="319"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Quality of Life (IBDQ)</title>
          <description>The Inflammatory Bowel Disease Questionnaire (IBDQ) score ranges from 32-224, with higher scores indicating greater disease-specific quality of life. An IBDQ score of greater than 168 has been shown to correlate with clinical remission in patients with Crohn's disease. Further, scores of 16 to 32 have been found to be significant changes when compared to baseline values.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="168.1" spread="34"/>
                    <measurement group_id="B2" value="172.3" spread="34.5"/>
                    <measurement group_id="B3" value="172.3" spread="33.1"/>
                    <measurement group_id="B4" value="171.0" spread="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Harvey Bradshaw Index</title>
        <description>Disease activity measure for patients with Crohn's disease. The activity index is comprised of 5 items. General well being (0-4), abdominal pain (0-3), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0-3), and complications (1 point per item). The total score is the sum of the individual parameters with scores less than 5 consistent with clinical remission. The minimum score is 0 and there is no pre-specified maximum score as it depends on the number of liquids stools.</description>
        <time_frame>12 months</time_frame>
        <population>Crohn's disease population</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Home Monitoring</title>
            <description>Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
          </group>
          <group group_id="O3">
            <title>Home Monitoring Every Other Week</title>
            <description>Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
          </group>
        </group_list>
        <measure>
          <title>Harvey Bradshaw Index</title>
          <description>Disease activity measure for patients with Crohn's disease. The activity index is comprised of 5 items. General well being (0-4), abdominal pain (0-3), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0-3), and complications (1 point per item). The total score is the sum of the individual parameters with scores less than 5 consistent with clinical remission. The minimum score is 0 and there is no pre-specified maximum score as it depends on the number of liquids stools.</description>
          <population>Crohn's disease population</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="3.6"/>
                    <measurement group_id="O2" value="3.2" spread="3.4"/>
                    <measurement group_id="O3" value="4.2" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inflammatory Bowel Disease Questionnaire</title>
        <description>Description: A quality of life (QoL) questionnaire for patients with inflammatory bowel diseases [1].&#xD;
Format: 32 questions grouped into four dimensions: bowel, systemic, social, and emotional.&#xD;
Scoring: Scores for each question range from 1 (poorest QoL) to 7 (best QoL). The overall range for the 32 item questionnaire is 32-224 with higher scores indicate better QoL. Scores &gt;168 have been shown to correlate with clinical remission in patients with Crohn's disease and a change in score of 16-32 points is considered significant.</description>
        <time_frame>12 months</time_frame>
        <population>IBDQ Scores</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Home Monitoring</title>
            <description>Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
          </group>
          <group group_id="O3">
            <title>Home Monitoring Every Other Week</title>
            <description>Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
          </group>
        </group_list>
        <measure>
          <title>Inflammatory Bowel Disease Questionnaire</title>
          <description>Description: A quality of life (QoL) questionnaire for patients with inflammatory bowel diseases [1].&#xD;
Format: 32 questions grouped into four dimensions: bowel, systemic, social, and emotional.&#xD;
Scoring: Scores for each question range from 1 (poorest QoL) to 7 (best QoL). The overall range for the 32 item questionnaire is 32-224 with higher scores indicate better QoL. Scores &gt;168 have been shown to correlate with clinical remission in patients with Crohn's disease and a change in score of 16-32 points is considered significant.</description>
          <population>IBDQ Scores</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="116"/>
                <count group_id="O3" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179.3" spread="28.2"/>
                    <measurement group_id="O2" value="179.2" spread="32.8"/>
                    <measurement group_id="O3" value="181.5" spread="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Care Utilization</title>
        <description>Total healthcare encounters 1 year post randomization (a specific scale was not used, simple counts of all encounters after randomization were carried out)</description>
        <time_frame>One year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Home Monitoring</title>
            <description>Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
          </group>
          <group group_id="O3">
            <title>Home Monitoring Every Other Week</title>
            <description>Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Care Utilization</title>
          <description>Total healthcare encounters 1 year post randomization (a specific scale was not used, simple counts of all encounters after randomization were carried out)</description>
          <units>Encounters</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="116"/>
                <count group_id="O3" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2435"/>
                    <measurement group_id="O2" value="2167"/>
                    <measurement group_id="O3" value="2481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Standard of Care</title>
          <description>Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.</description>
        </group>
        <group group_id="E2">
          <title>Weekly Home Monitoring</title>
          <description>Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
        </group>
        <group group_id="E3">
          <title>Home Monitoring Every Other Week</title>
          <description>Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.&#xD;
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Raymond K. Cross, MD, MS, AGAF</name_or_title>
      <organization>University of Maryland School of Medicine</organization>
      <phone>410-706-3387</phone>
      <email>rcross@som.umaryland.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01692743
org study id: HP-00049230
nct id: NCT01692743
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Improved methods are needed to monitor patients with inflammatory bowel disease. Telemedicine
      has shown promise in patients with other chronic diseases; pilot testing in our patients with
      inflammatory bowel disease demonstrated that the technology was feasible and improved
      clinical outcomes.

      The telemedicine system for patients with inflammatory bowel disease (Tele-IBD) should
      improve outcomes for patients, improve access to care in areas with limited resources, and
      decrease health care costs.
Introduction: Inflammatory bowel disease (IBD) is a chronic condition that results in
      debilitating symptoms. Although effective treatments exist, inadequate monitoring of symptoms
      and side effects, nonadherence, and poor patient knowledge are barriers to success.
      Telemedicine has been used in other chronic diseases to improve outcomes; pilot testing of
      telemedicine demonstrated that it is feasible and accepted in IBD. Our preliminary results
      from a randomized trial in participants with ulcerative colitis showed significant
      improvements in quality of life from baseline to one year in the telemanagement group.

      Study Design: Telemedicine for Patients with Inflammatory Bowel Disease (Tele-IBD) is a
      12-month, multicenter, randomized, controlled trial to assess the impact of Tele-IBD compared
      to standard care in participants with IBD. The aims of the study are to: (1) assess disease
      activity in participants with IBD using Tele-IBD compared to participants using standard
      care, (2) assess quality of life in participants with IBD using Tele-IBD compared to
      participants using standard care, and (3) estimate differences of person-level rates of
      utilization of health care resources in participants with IBD using Tele-IBD compared to
      participants using standard care.

      Methods: Tele-IBD consists of a web-portal and a weight scale. Participants answer questions
      about IBD symptoms, side effects and adherence using their home PC or a laptop with wireless
      Internet access provided to them for the study. A series of educational topics is
      administered via video messaging every 2-3 weeks. Tele-IBD participants complete self-testing
      weekly or every other week; the results are immediately available on the web-portal for
      review. Based on the responses, alerts and action plans are created for each participant. A
      nurse care coordinator consults the participant's medical provider for management changes if
      necessary. IBD patients evaluated at the University of Maryland, Baltimore, University of
      Pittsburgh, and Vanderbilt University will be invited to participate. Interested patients
      will be randomized in a 1:1:1 fashion to receive Tele-IBD weekly, Tele-IBD every other week,
      or standard care. Disease activity, quality of life, medical adherence, and utilization of
      health care resources will be assessed every 6 months for one year. In addition, provider
      interactions with patients in all three arms will be monitored and recorded.

      Expected Findings: Tele-IBD will decrease disease activity and improve quality of life
      through improved adherence and monitoring of symptoms, earlier and more effective
      implementation of therapy, more frequent patient-provider interactions, and improved patient
      self-management. Better control of IBD will result in decreased utilization of health care
      resources.

      Significance: If Tele-IBD improves outcomes, it is likely to be used to improve IBD care, to
      contain health care costs, to increase access to care, and to improve adherence with
      physician performance measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Harvey Bradshaw Index
time frame: 12 months
description: Disease activity measure for patients with Crohn's disease. The activity index is comprised of 5 items. General well being (0-4), abdominal pain (0-3), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0-3), and complications (1 point per item). The total score is the sum of the individual parameters with scores less than 5 consistent with clinical remission. The minimum score is 0 and there is no pre-specified maximum score as it depends on the number of liquids stools.
measure: Inflammatory Bowel Disease Questionnaire
time frame: 12 months
description: Description: A quality of life (QoL) questionnaire for patients with inflammatory bowel diseases [1].
Format: 32 questions grouped into four dimensions: bowel, systemic, social, and emotional.
Scoring: Scores for each question range from 1 (poorest QoL) to 7 (best QoL). The overall range for the 32 item questionnaire is 32-224 with higher scores indicate better QoL. Scores >168 have been shown to correlate with clinical remission in patients with Crohn's disease and a change in score of 16-32 points is considered significant.
measure: Health Care Utilization
time frame: One year
description: Total healthcare encounters 1 year post randomization (a specific scale was not used, simple counts of all encounters after randomization were carried out)
arm group label: Standard of Care
arm group type: No Intervention
description: Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.
arm group label: Weekly Home Monitoring
arm group type: Experimental
description: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
arm group label: Home Monitoring Every Other Week
arm group type: Experimental
description: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
intervention type: Behavioral
intervention name: Home Monitoring
description: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
arm group label: Weekly Home Monitoring
intervention type: Behavioral
intervention name: Home Monitoring
description: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
arm group label: Home Monitoring Every Other Week
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raymond K Cross, MD, MS, AGAF
role: Principal Investigator
affiliation: University of Maryland, College Park
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Raymond Cross
investigator title: Principal Investigator
mesh term: Crohn Disease
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 