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/NCT05994716</url>
    </required_header>
    <id_info>
      <org_study_id>2023-1</org_study_id>
      <nct_id>NCT05994716</nct_id>
    </id_info>
    <brief_title>Effectiveness of Telemedicine in Inflammatory Bowel Disease</brief_title>
    <official_title>Effectiveness of Telemedicine in Inflammatory Bowel Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sechenov University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department</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>
        This is a prospective, randomized study to assess the impact of telemedicine (telemonitoring,&#xD;
        tele-education and tele-consultation) on the patients with Inflammatory Bowel Disease (IBD).&#xD;
        The main study objective is to evaluate the impact of telemedicine on the quality of life in&#xD;
        IBD. The secondary study endpoints are to minimize adverse drug reactions, to reduce the&#xD;
        number of IBD relapses, to improve medication adherence, to improve satisfaction with medical&#xD;
        care, to minimize the use of healthcare resources.&#xD;
  &#xD;
        It is planned to enroll 60 patients. The study duration is 1 year (6 months - patient&#xD;
        enrollment, 6 months - telemedical intervention).&#xD;
  &#xD;
        The study consists of 3 stages. The first stage is selection of patients with IBD after&#xD;
        treatment in the gastroenterology department. The second stage is face-to-face appointment&#xD;
        and general recommendations (for the observation group); monthly completion of questionnaires&#xD;
        on the web-platform, possibility to contact with doctor via chat or phone call, access to&#xD;
        educational information (for the intervention group). The third stage is the evaluation of&#xD;
        IBD activity (re-hospitalization after 6 months), psychological well-being, quality of life,&#xD;
        medication adherence, etc.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Number of volunteers: 60 patients with IBD Study duration: 1 year (6 months - patient&#xD;
        enrollment, 6 months - telemedical intervention).&#xD;
  &#xD;
        Inclusion criteria:&#xD;
  &#xD;
          -  Age ≥18 years old.&#xD;
  &#xD;
          -  Signed informed consent.&#xD;
  &#xD;
          -  Diagnosis: Crohn disease (ICD-10 codes K50.0, K50.1, K50.8, K50.9) and Ulcerative&#xD;
             colitis (K51.0, K51.2, 51.3, K51.5, K51.8).&#xD;
  &#xD;
        Exclusion criteria:&#xD;
  &#xD;
          -  Severe cognitive dysfunction;&#xD;
  &#xD;
          -  Acute mental illness;&#xD;
  &#xD;
          -  Lack of technical ability to take part in telemedical intervention (does not have the&#xD;
             skills to work with a smartphone, computer, tablet, there is no appropriate technical&#xD;
             means);&#xD;
  &#xD;
          -  Participation in other clinical studies.&#xD;
  &#xD;
          -  Oncological diseases requiring active treatment.&#xD;
  &#xD;
          -  Patients who denied signing informed consent.&#xD;
  &#xD;
        Outpatient observation with connection to the telemonitoring program - 30 participants.&#xD;
  &#xD;
        Outpatient monitoring without connecting to the telemonitoring program - 30 participants.&#xD;
  &#xD;
        Study design:&#xD;
  &#xD;
        Stage 1: selection of the patients with IBD that meet the inclusion criteria after inpatient&#xD;
        treatment in the gastroenterology department. Randomization of participants into two groups:&#xD;
        face-to-face outpatient observation and observation using telemedicine technologies. Signing&#xD;
        informed consent, filling out questionnaires:&#xD;
  &#xD;
          1. Simple Clinical Colitis Activity Index (SCCAI) questionnaire for patients with&#xD;
             ulcerative colitis / Harvey-Bradshaw index (HBI) questionnaire for patients with Crohn&#xD;
             disease;&#xD;
  &#xD;
          2. World Health Organization's Quality of Life (WHOQOL-26): questionnaire for assessing&#xD;
             health-related quality of life;&#xD;
  &#xD;
          3. SIBDQ: Short Inflammatory Bowel Disease Questionnaire;&#xD;
  &#xD;
          4. Work Productivity and Activity Impairment Questionnaire (WPAI): questionnaire used to&#xD;
             evaluate work productivity and activity impairment;&#xD;
  &#xD;
          5. Hospital Anxiety and Depression Scale (HADS);&#xD;
  &#xD;
          6. Toronto Alexithymia Scale (TAS-26): used to evaluate alexithymia (a risk factor for the&#xD;
             development of psychosomatic diseases);&#xD;
  &#xD;
          7. Visceral Sensitivity Index (VSI): Special gastroenterological questionnaire to determine&#xD;
             the index of visceral sensitivity;&#xD;
  &#xD;
          8. PSQ-18: Patient Satisfaction Questionnaire;&#xD;
  &#xD;
          9. General Medication Adherence Scale (GMAS) to determine the adherence to the therapy.&#xD;
  &#xD;
        Stage 2: for the outpatient observation group: one face-to-face appointment, general&#xD;
        recommendations.&#xD;
  &#xD;
        For the telemonitoring group patients log in to the web platform at least once a month. When&#xD;
        the patient log in to the telemedicine platform the following scorings must be filled out:1)&#xD;
        SCCAI for Ulcerative colitis and Harvey-Bradshaw index for Crohn disease. 2) IBD disk&#xD;
        questionnaire to evaluate disease dynamics. The results of the scoring systems will appear to&#xD;
        the health care professionals and patients in a traffic light manner (red, yellow and green).&#xD;
        If patient has a recurrence of the disease, he will be instructed to contact a doctor.&#xD;
  &#xD;
        Patients from intervention group will have the possibility of online consultation with a&#xD;
        gastroenterologist upon request via chat or phone call and access to educational information&#xD;
        about IBD, necessary lifestyle changes, dietary recommendations.&#xD;
  &#xD;
        To be assessed in both groups during the entire observation period:&#xD;
  &#xD;
          -  Frequency of scheduled and unscheduled visits, hospitalizations in medical&#xD;
             organizations, assistance within the statutory health insurance system;&#xD;
  &#xD;
          -  The number of surgical interventions associated with IBD;&#xD;
  &#xD;
          -  Activity impairment and work productivity;&#xD;
  &#xD;
          -  Mortality from complications of IBD;&#xD;
  &#xD;
          -  State and patient spending on healthcare;&#xD;
  &#xD;
        Stage 3: re-hospitalization of both groups 6 months after randomization in order to evaluate&#xD;
        IBD activity (laboratory and instrumental examinations).&#xD;
  &#xD;
        Re-completion of all questionnaires for both groups.&#xD;
  &#xD;
        The purpose of this study is to evaluate telemedicine impact in IBD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">April 25, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2024</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>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change the quality of life in IBD measured by SIBDQ</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Change the quality of life in IBD according to Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Max value is 70, min value is 10. Value less than 50 means poor heath related quality of life. Higher score means better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change the quality of life in IBD measured by WHOQOL-26</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Change the quality of life in IBD according to World Health Organization's Quality of Life (WHOQOL-26) questionnaire. Higher score means better outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maintaining/achieving clinical remission of Crohn Disease</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Clinical remission of Crohn Disease will be measured by Harvey-Bradshaw Index (HBI) questionnaire. Lower score means better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maintaining/achieving clinical remission of Ulcerative Colitis</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Clinical remission of Ulcerative will be measured by Colitis Simple Clinical Colitis Activity Index (SCCAI) questionnaire. Lower score means better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maintaining/achieving clinical remission of IBD</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Clinical remission of IBD will be measured by Inflammatory Bowel Disease disk (IBD disk) questionnaire. Higher score means better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maintaining/achieving endoscopic remission of IBD</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Endoscopic remission of IBD will be measured by colonoscopy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maintaining/achieving histological remission of IBD</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Histological remission of IBD will be measured via biopsy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change the number adverse drug reactions in IBD</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Change the number adverse drug reactions in IBD</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change satisfaction with treatment of patients with IBD</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Change satisfaction with treatment of patients with IBD according to Patient Satisfaction Questionnaire (PSQ-18). Max value is 90, min value is 18. Higher score means better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change psychological well-being of patients with IBD measured by HADS</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Change psychological well-being of patients with IBD according to Hospital Anxiety and Depression Scale (HADS). Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Score 8-10 for doubtful cases and ≥11 for definite cases of depression and anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change psychological well-being of patients with IBD measured by VSI</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Change psychological well-being of patients with IBD according to Visceral Sensitivity Index (VSI). Min value is 0, max value is 75. Lower score means better outcome. Score from 31 to 75 means visceral hypersensitivity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change psychological well-being of patients with IBD measured by TAS-26</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Change psychological well-being of patients with IBD according to Toronto Alexithymia Scale (TAS-26) questionnaire. Min value 26, max value 130. Score higher than 63 means worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change the number of surgical interventions in IBD</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Evaluation of the use of surgical interventions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change the number of hospitalizations in IBD</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Evaluation of the number of hospitalizations</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change the number of outpatient visits in IBD</measure>
      <time_frame>Upon completion, up to 6 months</time_frame>
      <description>Evaluation of the number of outpatient visits</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Inflammatory Bowel Diseases</condition>
    <condition>Crohn Disease</condition>
    <condition>Ulcerative Colitis</condition>
    <arm_group>
      <arm_group_label>Observation group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Telemedical intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Telemedical intervention</intervention_name>
      <description>A) Monthly completion of questionnaires on the web platform: 1) SCCAI for Ulcerative colitis and Harvey-Bradshaw index for Crohn disease. 2) IBD disk questionnaire to evaluate disease dynamics.&#xD;
  B) Possibility of online consultation with a gastroenterologist upon request via chat or phone call.&#xD;
  C) Access to educational information about IBD, necessary lifestyle changes, dietary recommendations.</description>
      <arm_group_label>Telemedical intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years old.&#xD;
  &#xD;
            -  Signed informed consent.&#xD;
  &#xD;
            -  Diagnosis: Crohn disease (ICD-10 codes K50.0, K50.1, K50.8, K50.9) and Ulcerative&#xD;
               colitis (K51.0, K51.2, 51.3, K51.5, K51.8).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe cognitive dysfunction;&#xD;
  &#xD;
            -  Acute mental illness;&#xD;
  &#xD;
            -  Lack of technical ability to take part in telemedical intervention (does not have the&#xD;
               skills to work with a smartphone, computer, tablet, there is no appropriate technical&#xD;
               means);&#xD;
  &#xD;
            -  Participation in other clinical studies.&#xD;
  &#xD;
            -  Oncological diseases requiring active treatment.&#xD;
  &#xD;
            -  Patients who denied signing informed consent.&#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>Anton V Vladzymyrskyy</last_name>
      <role>Study Director</role>
      <affiliation>Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department</name>
        <address>
          <city>Moscow</city>
          <country>Russian Federation</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Inflammatory Bowel Disease</keyword>
    <keyword>Telemedicine</keyword>
    <keyword>Telemonitoring</keyword>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05994716
  org study id: 2023-1
  nct id: NCT05994716
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, randomized study to assess the impact of telemedicine (telemonitoring,
        tele-education and tele-consultation) on the patients with Inflammatory Bowel Disease (IBD).
        The main study objective is to evaluate the impact of telemedicine on the quality of life in
        IBD. The secondary study endpoints are to minimize adverse drug reactions, to reduce the
        number of IBD relapses, to improve medication adherence, to improve satisfaction with medical
        care, to minimize the use of healthcare resources.
  
        It is planned to enroll 60 patients. The study duration is 1 year (6 months - patient
        enrollment, 6 months - telemedical intervention).
  
        The study consists of 3 stages. The first stage is selection of patients with IBD after
        treatment in the gastroenterology department. The second stage is face-to-face appointment
        and general recommendations (for the observation group); monthly completion of questionnaires
        on the web-platform, possibility to contact with doctor via chat or phone call, access to
        educational information (for the intervention group). The third stage is the evaluation of
        IBD activity (re-hospitalization after 6 months), psychological well-being, quality of life,
        medication adherence, etc.
  Number of volunteers: 60 patients with IBD Study duration: 1 year (6 months - patient
        enrollment, 6 months - telemedical intervention).
  
        Inclusion criteria:
  
          -  Age ≥18 years old.
  
          -  Signed informed consent.
  
          -  Diagnosis: Crohn disease (ICD-10 codes K50.0, K50.1, K50.8, K50.9) and Ulcerative
             colitis (K51.0, K51.2, 51.3, K51.5, K51.8).
  
        Exclusion criteria:
  
          -  Severe cognitive dysfunction;
  
          -  Acute mental illness;
  
          -  Lack of technical ability to take part in telemedical intervention (does not have the
             skills to work with a smartphone, computer, tablet, there is no appropriate technical
             means);
  
          -  Participation in other clinical studies.
  
          -  Oncological diseases requiring active treatment.
  
          -  Patients who denied signing informed consent.
  
        Outpatient observation with connection to the telemonitoring program - 30 participants.
  
        Outpatient monitoring without connecting to the telemonitoring program - 30 participants.
  
        Study design:
  
        Stage 1: selection of the patients with IBD that meet the inclusion criteria after inpatient
        treatment in the gastroenterology department. Randomization of participants into two groups:
        face-to-face outpatient observation and observation using telemedicine technologies. Signing
        informed consent, filling out questionnaires:
  
          1. Simple Clinical Colitis Activity Index (SCCAI) questionnaire for patients with
             ulcerative colitis / Harvey-Bradshaw index (HBI) questionnaire for patients with Crohn
             disease;
  
          2. World Health Organization's Quality of Life (WHOQOL-26): questionnaire for assessing
             health-related quality of life;
  
          3. SIBDQ: Short Inflammatory Bowel Disease Questionnaire;
  
          4. Work Productivity and Activity Impairment Questionnaire (WPAI): questionnaire used to
             evaluate work productivity and activity impairment;
  
          5. Hospital Anxiety and Depression Scale (HADS);
  
          6. Toronto Alexithymia Scale (TAS-26): used to evaluate alexithymia (a risk factor for the
             development of psychosomatic diseases);
  
          7. Visceral Sensitivity Index (VSI): Special gastroenterological questionnaire to determine
             the index of visceral sensitivity;
  
          8. PSQ-18: Patient Satisfaction Questionnaire;
  
          9. General Medication Adherence Scale (GMAS) to determine the adherence to the therapy.
  
        Stage 2: for the outpatient observation group: one face-to-face appointment, general
        recommendations.
  
        For the telemonitoring group patients log in to the web platform at least once a month. When
        the patient log in to the telemedicine platform the following scorings must be filled out:1)
        SCCAI for Ulcerative colitis and Harvey-Bradshaw index for Crohn disease. 2) IBD disk
        questionnaire to evaluate disease dynamics. 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 patient has a recurrence of the disease, he will be instructed to contact a doctor.
  
        Patients from intervention group will have the possibility of online consultation with a
        gastroenterologist upon request via chat or phone call and access to educational information
        about IBD, necessary lifestyle changes, dietary recommendations.
  
        To be assessed in both groups during the entire observation period:
  
          -  Frequency of scheduled and unscheduled visits, hospitalizations in medical
             organizations, assistance within the statutory health insurance system;
  
          -  The number of surgical interventions associated with IBD;
  
          -  Activity impairment and work productivity;
  
          -  Mortality from complications of IBD;
  
          -  State and patient spending on healthcare;
  
        Stage 3: re-hospitalization of both groups 6 months after randomization in order to evaluate
        IBD activity (laboratory and instrumental examinations).
  
        Re-completion of all questionnaires for both groups.
  
        The purpose of this study is to evaluate telemedicine impact in IBD.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Change the quality of life in IBD measured by SIBDQ
  time frame: Upon completion, up to 6 months
  description: Change the quality of life in IBD according to Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Max value is 70, min value is 10. Value less than 50 means poor heath related quality of life. Higher score means better outcome.
  measure: Change the quality of life in IBD measured by WHOQOL-26
  time frame: Upon completion, up to 6 months
  description: Change the quality of life in IBD according to World Health Organization's Quality of Life (WHOQOL-26) questionnaire. Higher score means better outcome.
  measure: Maintaining/achieving clinical remission of Crohn Disease
  time frame: Upon completion, up to 6 months
  description: Clinical remission of Crohn Disease will be measured by Harvey-Bradshaw Index (HBI) questionnaire. Lower score means better outcome.
  measure: Maintaining/achieving clinical remission of Ulcerative Colitis
  time frame: Upon completion, up to 6 months
  description: Clinical remission of Ulcerative will be measured by Colitis Simple Clinical Colitis Activity Index (SCCAI) questionnaire. Lower score means better outcome.
  measure: Maintaining/achieving clinical remission of IBD
  time frame: Upon completion, up to 6 months
  description: Clinical remission of IBD will be measured by Inflammatory Bowel Disease disk (IBD disk) questionnaire. Higher score means better outcome.
  measure: Maintaining/achieving endoscopic remission of IBD
  time frame: Upon completion, up to 6 months
  description: Endoscopic remission of IBD will be measured by colonoscopy.
  measure: Maintaining/achieving histological remission of IBD
  time frame: Upon completion, up to 6 months
  description: Histological remission of IBD will be measured via biopsy
  measure: Change the number adverse drug reactions in IBD
  time frame: Upon completion, up to 6 months
  description: Change the number adverse drug reactions in IBD
  measure: Change satisfaction with treatment of patients with IBD
  time frame: Upon completion, up to 6 months
  description: Change satisfaction with treatment of patients with IBD according to Patient Satisfaction Questionnaire (PSQ-18). Max value is 90, min value is 18. Higher score means better outcome.
  measure: Change psychological well-being of patients with IBD measured by HADS
  time frame: Upon completion, up to 6 months
  description: Change psychological well-being of patients with IBD according to Hospital Anxiety and Depression Scale (HADS). Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Score 8-10 for doubtful cases and ≥11 for definite cases of depression and anxiety.
  measure: Change psychological well-being of patients with IBD measured by VSI
  time frame: Upon completion, up to 6 months
  description: Change psychological well-being of patients with IBD according to Visceral Sensitivity Index (VSI). Min value is 0, max value is 75. Lower score means better outcome. Score from 31 to 75 means visceral hypersensitivity.
  measure: Change psychological well-being of patients with IBD measured by TAS-26
  time frame: Upon completion, up to 6 months
  description: Change psychological well-being of patients with IBD according to Toronto Alexithymia Scale (TAS-26) questionnaire. Min value 26, max value 130. Score higher than 63 means worse outcome.
  measure: Change the number of surgical interventions in IBD
  time frame: Upon completion, up to 6 months
  description: Evaluation of the use of surgical interventions
  measure: Change the number of hospitalizations in IBD
  time frame: Upon completion, up to 6 months
  description: Evaluation of the number of hospitalizations
  measure: Change the number of outpatient visits in IBD
  time frame: Upon completion, up to 6 months
  description: Evaluation of the number of outpatient visits
  arm group label: Observation group
  arm group type: No Intervention
  arm group label: Telemedical intervention group
  arm group type: Experimental
  intervention type: Other
  intervention name: Telemedical intervention
  description: A) Monthly completion of questionnaires on the web platform: 1) SCCAI for Ulcerative colitis and Harvey-Bradshaw index for Crohn disease. 2) IBD disk questionnaire to evaluate disease dynamics.
  B) Possibility of online consultation with a gastroenterologist upon request via chat or phone call.
  C) Access to educational information about IBD, necessary lifestyle changes, dietary recommendations.
  arm group label: Telemedical intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anton V Vladzymyrskyy
  role: Study Director
  affiliation: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
  facility: 
  country: Russian Federation
  responsible party type: Sponsor
  mesh term: Crohn Disease
  mesh term: Intestinal Diseases
  mesh term: Inflammatory Bowel Diseases
  sharing ipd: No