<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/NCT03038984</url>
  </required_header>
  <id_info>
    <org_study_id>H-15005603</org_study_id>
    <nct_id>NCT03038984</nct_id>
  </id_info>
  <brief_title>Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients ?</brief_title>
  <official_title>Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients Tightly on Demand or Every 3 Months by Fecal Calprotectin and Disease Activity?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nordsjaellands Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nordsjaellands Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555.&#xD;
      The purpose of this study is to determine if the IBD patients doing home monitoring&#xD;
      (screening themselves on demand (OD) or every 3 months) have relative reduced rates of&#xD;
      colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD&#xD;
      patients are self-monitoring by web apps consisting of a short disease activity questionnaire&#xD;
      (DA) and fecal calprotectin (FC) on any smart phone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555.&#xD;
      Among 2.500 IBD patients the investigators have consecutively from the Gastroenterology&#xD;
      out-patient clinic at North Zealand University Hospital recruited in total 120 in the study.&#xD;
&#xD;
      At the out-patient consultation IBD patients has been informed about the project and the IBD&#xD;
      eHealth nurse has ensured that no exclusion criteria was met by the patients.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI &lt; 5&#xD;
      (Harvey &amp; Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI&#xD;
      &lt; 16) IBD patients who can read, speak and understand Danish. IBD patients that can take&#xD;
      advantage of the Internet and wireless network. 18 years or older.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
      IBD patients with severe disease activity HB &gt; 16 SCCAI ≥ 5 IBD patients with social, medical&#xD;
      or psychological issues of a more complex character. IBD patients with particularly complex&#xD;
      issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or&#xD;
      serious social impact.IBD patients who cannot attend due language barrier or cognitive&#xD;
      disorder. Age less than 18.&#xD;
&#xD;
      When the patient has agreed to participate in the study, randomized to either OD or 3. Months&#xD;
      (This has been done ClinicalTrials.gov ID: NCT02492555)&#xD;
&#xD;
      Patients log in to www.noh.constant-care.dk at least once every 3rd months throughout the&#xD;
      project period of 11 years in total (2015-2026). When the patient log in to the telemedicine&#xD;
      platform the following scorings must be filled out:&#xD;
&#xD;
        1. - Disease activity (DA), respectively SCCAI or HBI.&#xD;
&#xD;
        2. - Quality of life assessment, s-IBDQ&#xD;
&#xD;
        3. - FACIT (Fatigue score)&#xD;
&#xD;
        4. - MARS ( Medical Adherence Rating Scale)&#xD;
&#xD;
        5. - FC, fecal calprotectin mg / kg measured by the patient's own SMART phone, rapid home&#xD;
           test.&#xD;
&#xD;
      If the patients prefer to send the fecal samples for test, it will be analyzed in the ehealth&#xD;
      gastro lab. at the hospital with a SMART phone as well.&#xD;
&#xD;
      The results of the scoring systems will appear to the health care professionals and patients&#xD;
      in a traffic light manner (red, yellow and green).&#xD;
&#xD;
      If the patient experiences a recurrence of the disease, it moves from green to either yellow&#xD;
      or red area in the traffic graph, and patient will further be instructed to contact Gastro&#xD;
      medical clinic project nurse for an early consultation and decision on further treatment&#xD;
      initiative. This will also be indicated at the patient's website. If alarm symptoms occurs&#xD;
      patients are instructed to contact the project nurse. Thus patients are treated in accordance&#xD;
      to national and international guideline. By screening of the inflammation burden (web&#xD;
      algorithm), the decision is moving forward.&#xD;
&#xD;
      Patients logging in on demand, indicate disease activity, quality of life and FC at the&#xD;
      start, and subsequently when needed and at the end of the study (after 11 years from&#xD;
      inclusion).&#xD;
&#xD;
      At relapse, disease activity score and FC is settled and repeated no later than 7 days here&#xD;
      after. When the patient has reached remission (green) a new DA and FC test should be&#xD;
      performed to verify the remission.&#xD;
&#xD;
      The purpose of this study is to determine if the IBD patients doing home monitoring have&#xD;
      relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of&#xD;
      web monitoring. Relative reduced rates of colectomies etc. means - relative to standard care&#xD;
      but also if there is a difference between the two web screening procedures on these&#xD;
      endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Anticipated">August 2026</completion_date>
  <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>120 IBD patients has been randomized to screen for disease activity and FC either OD or every 3 months. 60 patients in each group</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>colectomies</measure>
    <time_frame>11 years</time_frame>
    <description>Number of colectomies</description>
  </primary_outcome>
  <primary_outcome>
    <measure>resections</measure>
    <time_frame>11 years</time_frame>
    <description>Number of resections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mortalities</measure>
    <time_frame>11 years</time_frame>
    <description>Number of deaths</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cancer</measure>
    <time_frame>11 years</time_frame>
    <description>cancer rates</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>11 years</time_frame>
    <description>number of hospitalizations and days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FC (Fecal Calprotectin) area under the curve (AUC)</measure>
    <time_frame>11 years</time_frame>
    <description>Both AUC total, but also as a red &gt;600 mg/kg, yellow (200-600 mg/kg) and green (below 200mg/kg ) AUC will be performed from the individualized curves</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple clinical colitis activity index (SCCAI): area under the curve (AUC)</measure>
    <time_frame>11 years</time_frame>
    <description>Both AUC total, but also as a red &gt;5, yellow (2-4) and green (&lt; 2 ) AUC will be performed from the individualized curves</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harvey-Bradshaw index (HBI): area under the curve (AUC)</measure>
    <time_frame>11 years</time_frame>
    <description>Both AUC total, but also as a red &gt;16 , yellow (6-16) and green (≤5) AUC will be performed from the individualized curves</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease course, Copenhagen IBD Disease course Type</measure>
    <time_frame>11 years</time_frame>
    <description>Based on epidemiology four figures have been developed to describe disease-course of IBD. These figures have been used in a retrospective study (Maagaard et al. 2016) to measure change in Disease course.The four figures depicting different types of disease courses is described as follows:&#xD;
Mild IBD with indolent course&#xD;
Mild IBD with aggressive course&#xD;
Chronic IBD with continuous course&#xD;
Chronic IBD with intermittent course The patients have to choose one figure representing their disease course type the best at inclusion and 11 years later</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Every 3 months</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>screening every 3rd month: (home monitoring: FC and DA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>On demand</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>screening On demand: (home monitoring: FC and DA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>At Home Screening procedure On demand</intervention_name>
    <description>Home monitoring is a supportive treatment. Patients are randomized to screen themselves on demand</description>
    <arm_group_label>On demand</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>At Home Screening procedure every 3 months</intervention_name>
    <description>Home monitoring is a supportive treatment. Patients are randomized to screen themselves every 3 months</description>
    <arm_group_label>Every 3 months</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI&#xD;
             &lt; 5 (Harvey &amp; Bradshaw Activity Index ) or in mild to moderate disease activity (&#xD;
             SCCAI 3-4, HBI &lt; 16). IBD patients who can read, speak and understand Danish. IBD&#xD;
             patients that can take advantage of the Internet and wireless network.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IBD patients with severe disease activity HB &gt; 16 SCCAI ≥ 5. IBD patients with social,&#xD;
             medical or psychological issues of a more complex character. IBD patients with&#xD;
             particularly complex issues such as drug and alcohol problems, severe mental /&#xD;
             psychiatric disorders and / or serious social impact.IBD patients who cannot attend&#xD;
             due language barrier or cognitive disorder.&#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>Pia Munkholm, Professor</last_name>
    <role>Study Director</role>
    <affiliation>North Zealand University Hospital</affiliation>
  </overall_official>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nordsjaellands Hospital</investigator_affiliation>
    <investigator_full_name>Dorit Vedel Ankersen</investigator_full_name>
    <investigator_title>PhD student, Msc food science and Msc Clinical nutrition</investigator_title>
  </responsible_party>
  <keyword>IBD</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>At-home monitoring</keyword>
  <keyword>Disease activity</keyword>
  <keyword>fecal calprotectin</keyword>
  <keyword>Total inflammation burden</keyword>
  <keyword>11 years follow up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03038984
org study id: H-15005603
nct id: NCT03038984
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555.
      The purpose of this study is to determine if the IBD patients doing home monitoring
      (screening themselves on demand (OD) or every 3 months) have relative reduced rates of
      colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD
      patients are self-monitoring by web apps consisting of a short disease activity questionnaire
      (DA) and fecal calprotectin (FC) on any smart phone.
This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555.
      Among 2.500 IBD patients the investigators have consecutively from the Gastroenterology
      out-patient clinic at North Zealand University Hospital recruited in total 120 in the study.

      At the out-patient consultation IBD patients has been informed about the project and the IBD
      eHealth nurse has ensured that no exclusion criteria was met by the patients.

      Inclusion criteria:

      IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5
      (Harvey & Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI
      < 16) IBD patients who can read, speak and understand Danish. IBD patients that can take
      advantage of the Internet and wireless network. 18 years or older.

      Exclusion criteria:

      IBD patients with severe disease activity HB > 16 SCCAI ≥ 5 IBD patients with social, medical
      or psychological issues of a more complex character. IBD patients with particularly complex
      issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or
      serious social impact.IBD patients who cannot attend due language barrier or cognitive
      disorder. Age less than 18.

      When the patient has agreed to participate in the study, randomized to either OD or 3. Months
      (This has been done ClinicalTrials.gov ID: NCT02492555)

      Patients log in to www.noh.constant-care.dk at least once every 3rd months throughout the
      project period of 11 years in total (2015-2026). When the patient log in to the telemedicine
      platform the following scorings must be filled out:

        1. - Disease activity (DA), respectively SCCAI or HBI.

        2. - Quality of life assessment, s-IBDQ

        3. - FACIT (Fatigue score)

        4. - MARS ( Medical Adherence Rating Scale)

        5. - FC, fecal calprotectin mg / kg measured by the patient's own SMART phone, rapid home
           test.

      If the patients prefer to send the fecal samples for test, it will be analyzed in the ehealth
      gastro lab. at the hospital with a SMART phone as well.

      The results of the scoring systems will appear to the health care professionals and patients
      in a traffic light manner (red, yellow and green).

      If the patient experiences a recurrence of the disease, it moves from green to either yellow
      or red area in the traffic graph, and patient will further be instructed to contact Gastro
      medical clinic project nurse for an early consultation and decision on further treatment
      initiative. This will also be indicated at the patient's website. If alarm symptoms occurs
      patients are instructed to contact the project nurse. Thus patients are treated in accordance
      to national and international guideline. By screening of the inflammation burden (web
      algorithm), the decision is moving forward.

      Patients logging in on demand, indicate disease activity, quality of life and FC at the
      start, and subsequently when needed and at the end of the study (after 11 years from
      inclusion).

      At relapse, disease activity score and FC is settled and repeated no later than 7 days here
      after. When the patient has reached remission (green) a new DA and FC test should be
      performed to verify the remission.

      The purpose of this study is to determine if the IBD patients doing home monitoring have
      relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of
      web monitoring. Relative reduced rates of colectomies etc. means - relative to standard care
      but also if there is a difference between the two web screening procedures on these
      endpoints.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 120 IBD patients has been randomized to screen for disease activity and FC either OD or every 3 months. 60 patients in each group
primary purpose: Supportive Care
masking: None (Open Label)
measure: colectomies
time frame: 11 years
description: Number of colectomies
measure: resections
time frame: 11 years
description: Number of resections
measure: mortalities
time frame: 11 years
description: Number of deaths
measure: cancer
time frame: 11 years
description: cancer rates
measure: Hospitalizations
time frame: 11 years
description: number of hospitalizations and days
measure: FC (Fecal Calprotectin) area under the curve (AUC)
time frame: 11 years
description: Both AUC total, but also as a red >600 mg/kg, yellow (200-600 mg/kg) and green (below 200mg/kg ) AUC will be performed from the individualized curves
measure: Simple clinical colitis activity index (SCCAI): area under the curve (AUC)
time frame: 11 years
description: Both AUC total, but also as a red >5, yellow (2-4) and green (< 2 ) AUC will be performed from the individualized curves
measure: Harvey-Bradshaw index (HBI): area under the curve (AUC)
time frame: 11 years
description: Both AUC total, but also as a red >16 , yellow (6-16) and green (≤5) AUC will be performed from the individualized curves
measure: Disease course, Copenhagen IBD Disease course Type
time frame: 11 years
description: Based on epidemiology four figures have been developed to describe disease-course of IBD. These figures have been used in a retrospective study (Maagaard et al. 2016) to measure change in Disease course.The four figures depicting different types of disease courses is described as follows:
Mild IBD with indolent course
Mild IBD with aggressive course
Chronic IBD with continuous course
Chronic IBD with intermittent course The patients have to choose one figure representing their disease course type the best at inclusion and 11 years later
arm group label: Every 3 months
arm group type: Experimental
description: screening every 3rd month: (home monitoring: FC and DA)
arm group label: On demand
arm group type: Active Comparator
description: screening On demand: (home monitoring: FC and DA)
intervention type: Behavioral
intervention name: At Home Screening procedure On demand
description: Home monitoring is a supportive treatment. Patients are randomized to screen themselves on demand
arm group label: On demand
intervention type: Behavioral
intervention name: At Home Screening procedure every 3 months
description: Home monitoring is a supportive treatment. Patients are randomized to screen themselves every 3 months
arm group label: Every 3 months
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pia Munkholm, Professor
role: Study Director
affiliation: North Zealand University Hospital
responsible party type: Principal Investigator
investigator affiliation: Nordsjaellands Hospital
investigator full name: Dorit Vedel Ankersen
investigator title: PhD student, Msc food science and Msc Clinical nutrition
mesh term: Inflammatory Bowel Diseases
sharing ipd: No