xml: <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/NCT06031038</url>
    </required_header>
    <id_info>
      <org_study_id>M-TECCU</org_study_id>
      <nct_id>NCT06031038</nct_id>
    </id_info>
    <brief_title>Impact of Telemonitoring in the Management of Complex IBD in Spain: M-TECCU</brief_title>
    <acronym>M-TECCU</acronym>
    <official_title>Impact of Telemonitoring in the Management of Complex Inflammatory Bowel Disease in Spain: TECCU Multicenter Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa</source>
    <oversight_info>
      <has_dmc>No</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>
        M-TECCU is a study: multicenter, randomized and open. It consists of two parallel groups to&#xD;
        compare the efficacy of the TECCU web-based telemonitoring system to achieve and maintain&#xD;
        activity remission in patients with moderate-high complexity inflammatory bowel disease&#xD;
        compared to usual clinical practice.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Clinical trial with an open, randomized and controlled non-inferiority medical device, in&#xD;
        which the impact of a follow-up method through a web telemonitoring platform on the time in&#xD;
        clinical remission of patients with complex IBD is evaluated, in comparison with the usual&#xD;
        follow-up in outpatient clinics.&#xD;
  &#xD;
        Patients with complex IBD are considered to be those who receive treatment with&#xD;
        immunosuppressants or biological therapies to control the luminal activity of their disease.&#xD;
        Patients carry out periodic controls for the disease according to a pre-established schedule&#xD;
        based on national and international clinical guidelines. The patients in the telemonitoring&#xD;
        group (G_TECCU) follow these controls through the TECCU platform, a web system that allows&#xD;
        them to fill in questionnaires related to the clinical variables under study and communicate&#xD;
        freely with healthcare personnel during pre-established controls and when the patient deems&#xD;
        it necessary. On the other hand, the patients of the control group (G_Control) carry out the&#xD;
        controls according to the same schedule as G_TECCU, but following the usual clinical&#xD;
        practice.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 2020</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Actual">April 30, 2023</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>To compare the time in remission of patients with complex IBD (require immunosuppressants and/or biologics to control their luminal inflammatory activity) controlled with the TECCU intervention (G_TECCU) with respect to usual clinical practice (G_Control) after 52 weeks of follow-up.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>clinical remission</measure>
      <time_frame>52 weeks</time_frame>
      <description>To compare the time in remission of patients with complex IBD (require immunosuppressants and/or biologics to control their luminal inflammatory activity) controlled with the TECCU intervention (G_TECCU) with respect to usual clinical practice (G_Control) after 52 weeks of follow-up.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>cost-effectiveness</measure>
      <time_frame>52 weeks</time_frame>
      <description>Carry out a cost-effectiveness analysis based on the direct and indirect costs generated during the 12-month follow-up in G_TECCU and G_control.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">290</enrollment>
    <condition>Inflammatory Bowel Disease</condition>
    <condition>Crohn's Disease</condition>
    <condition>Ulcerative Colitis</condition>
    <condition>Telemedicine</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>TECCU group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TECCU Software</intervention_name>
      <description>patient monitoring by software application</description>
      <arm_group_label>TECCU group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients ≥18a&#xD;
  &#xD;
            -  IBD (CD or UC) diagnosed according to ECCO criteria&#xD;
  &#xD;
            -  Start treatment with immunosuppressants and/or biological therapies due to luminal&#xD;
               activity&#xD;
  &#xD;
            -  signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Presence of active perianal disease, ileoanal reservoir, or definitive stoma&#xD;
  &#xD;
            -  Patients with mental illness or other poorly controlled illness&#xD;
  &#xD;
            -  Patients with active cancer diagnosis&#xD;
  &#xD;
            -  Terminal patients and/or palliative care (SECPAL)&#xD;
  &#xD;
            -  Family members of the research team&#xD;
  &#xD;
            -  Patients without a telephone line to connect with a mobile, tablet and/or computer /&#xD;
               Inability to drive&#xD;
  &#xD;
            -  Cognitive or linguistic difficulties&#xD;
  &#xD;
            -  Patients included in another experimental study&#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>Castany Pla</last_name>
      <role>Principal Investigator</role>
      <affiliation>Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hospital Universitario y Politécnico la Fe</name>
        <address>
          <city>Valencia</city>
          <zip>46026</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Del Hoyo J, Nos P, Faubel R, Munoz D, Dominguez D, Bastida G, Valdivieso B, Correcher M, Aguas M. A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Nov 27;20(11):e11602. doi: 10.2196/11602.</citation>
      <PMID>30482739</PMID>
    </reference>
    <reference>
      <citation>Aguas M, Del Hoyo J, Faubel R, Munoz D, Dominguez D, Bastida G, Navarro B, Barrios A, Valdivieso B, Correcher M, Nos P. A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2018 Dec 21;7(12):e190. doi: 10.2196/resprot.9639.</citation>
      <PMID>30578197</PMID>
    </reference>
    <reference>
      <citation>Del Hoyo J, Aguas M. Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Jan;19(1):206-207. doi: 10.1016/j.cgh.2020.06.016. No abstract available.</citation>
      <PMID>33339564</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Crohn Disease</mesh_term>
      <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>
  
  
text: 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/NCT06031038
  org study id: M-TECCU
  nct id: NCT06031038
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  M-TECCU is a study: multicenter, randomized and open. It consists of two parallel groups to
        compare the efficacy of the TECCU web-based telemonitoring system to achieve and maintain
        activity remission in patients with moderate-high complexity inflammatory bowel disease
        compared to usual clinical practice.
  Clinical trial with an open, randomized and controlled non-inferiority medical device, in
        which the impact of a follow-up method through a web telemonitoring platform on the time in
        clinical remission of patients with complex IBD is evaluated, in comparison with the usual
        follow-up in outpatient clinics.
  
        Patients with complex IBD are considered to be those who receive treatment with
        immunosuppressants or biological therapies to control the luminal activity of their disease.
        Patients carry out periodic controls for the disease according to a pre-established schedule
        based on national and international clinical guidelines. The patients in the telemonitoring
        group (G_TECCU) follow these controls through the TECCU platform, a web system that allows
        them to fill in questionnaires related to the clinical variables under study and communicate
        freely with healthcare personnel during pre-established controls and when the patient deems
        it necessary. On the other hand, the patients of the control group (G_Control) carry out the
        controls according to the same schedule as G_TECCU, but following the usual clinical
        practice.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: To compare the time in remission of patients with complex IBD (require immunosuppressants and/or biologics to control their luminal inflammatory activity) controlled with the TECCU intervention (G_TECCU) with respect to usual clinical practice (G_Control) after 52 weeks of follow-up.
  primary purpose: Other
  masking: None (Open Label)
  measure: clinical remission
  time frame: 52 weeks
  description: To compare the time in remission of patients with complex IBD (require immunosuppressants and/or biologics to control their luminal inflammatory activity) controlled with the TECCU intervention (G_TECCU) with respect to usual clinical practice (G_Control) after 52 weeks of follow-up.
  measure: cost-effectiveness
  time frame: 52 weeks
  description: Carry out a cost-effectiveness analysis based on the direct and indirect costs generated during the 12-month follow-up in G_TECCU and G_control.
  arm group label: control group
  arm group type: No Intervention
  arm group label: TECCU group
  arm group type: Active Comparator
  intervention type: Other
  intervention name: TECCU Software
  description: patient monitoring by software application
  arm group label: TECCU group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Castany Pla
  role: Principal Investigator
  affiliation: Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
  facility: 
  country: Spain
  citation: Del Hoyo J, Nos P, Faubel R, Munoz D, Dominguez D, Bastida G, Valdivieso B, Correcher M, Aguas M. A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Nov 27;20(11):e11602. doi: 10.2196/11602.
  PMID: 30482739
  citation: Aguas M, Del Hoyo J, Faubel R, Munoz D, Dominguez D, Bastida G, Navarro B, Barrios A, Valdivieso B, Correcher M, Nos P. A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2018 Dec 21;7(12):e190. doi: 10.2196/resprot.9639.
  PMID: 30578197
  citation: Del Hoyo J, Aguas M. Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Jan;19(1):206-207. doi: 10.1016/j.cgh.2020.06.016. No abstract available.
  PMID: 33339564
  responsible party type: Sponsor
  mesh term: Crohn Disease
  mesh term: Intestinal Diseases
  mesh term: Inflammatory Bowel Diseases