<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/NCT01701791</url>
  </required_header>
  <id_info>
    <org_study_id>RF-2010-2316063</org_study_id>
    <nct_id>NCT01701791</nct_id>
  </id_info>
  <brief_title>Telemedicine for Depression in Primary Care</brief_title>
  <official_title>The Efficacy of Telemedicine for Improving Depression Outcomes in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Centro San Giovanni di Dio Fatebenefratelli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Centro San Giovanni di Dio Fatebenefratelli</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: In Italy, several recent studies found that a large percentage of patients&#xD;
      attending Primary Care (PC) clinics meet criteria for at least one common mental disorder, as&#xD;
      they show high rates of depression, anxiety, and co-morbid anxiety and depression. These&#xD;
      patients may experience significant functional impairment and suffer from unexplained somatic&#xD;
      symptoms, and often remain undetected and untreated. Consistent evidence for the&#xD;
      effectiveness of organized care programs for depression, by improving quality of care and&#xD;
      treatment adherence, is now available. Fundamental elements of these programs include&#xD;
      algorithms to prompt the proper and timely implementation of evidence-based treatments,&#xD;
      structured outcome assessment and systematic outreach. Telemedicine tools may represent a&#xD;
      valuable strategy for improving depression outcomes in PC.&#xD;
&#xD;
      Aims: 1.To develop and employ computer-based assessment to more accurately and timely detect&#xD;
      patient depression in PC settings; 2.To evaluate the feasibility and effectiveness of a care&#xD;
      support program developed in conjunction with the PC-based assessment for patients suffering&#xD;
      from depression, as based on two main objectives: 2a.To support GP decisions with treatment&#xD;
      algorithms and improve the quality of GP and mental health service collaboration; 2b.To&#xD;
      improve patient compliance and treatment adherence by using appropriate telecommunication&#xD;
      tools and technologically advanced tools to conduct systematic routine assessment. Although&#xD;
      much of this system will be computer-based, live telephonic and in-person contacts will also&#xD;
      be included as needed.&#xD;
&#xD;
      Study Design: The study is a randomized controlled trial, involving four PC group clinics&#xD;
      (GCs) located in two areas of Northern Italy. Two PC clinics will use the experimental&#xD;
      protocol; the other two will serve as controls.&#xD;
&#xD;
      The study will compare two different conditions:&#xD;
&#xD;
        -  Group 1 (experimental): GPs will use a Computer Decision Support System with treatment&#xD;
           algorithms and advice and supervision from a consultant psychiatrist. Patients will&#xD;
           receive reminders via mobile texting or automatic mobile (or landline) phone calls to&#xD;
           improve adherence to the treatment prescribed.&#xD;
&#xD;
        -  Group 2 (control): GPs will provide TAU, will make their own decisions and will&#xD;
           therefore not use the CDSS. Patients will not receive any reminders. All enrolled&#xD;
           patients will be administered and will fill in the IDS-SR at baseline, 3 and 6-months:&#xD;
           the IDS-SR score will be used as a primary endpoint.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients reaching remission</measure>
    <time_frame>6 months</time_frame>
    <description>The primary end-point will be the proportion of patients reaching remission by 6 months, as represented by an exit IDS-SR score of &lt;or=12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of GP appointments actually attended during follow-up</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Computerized Decision Support System (CDSS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GPs will use a CDSS with treatment algorithms, supervision from a consultant psychiatrist, and despatch to patients of reminders via mobile texting or automatic mobile (or landline) phone calls to improve adherence to the treatment prescribed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>GPs will provide TAU, will make their own decisions and will therefore not use the CDSS. Patients will not receive any reminders.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computerized Decision Support System</intervention_name>
    <arm_group_label>Computerized Decision Support System (CDSS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18-65 years&#xD;
&#xD;
          -  PHQ-9 score of &gt;or=14 at baseline&#xD;
&#xD;
          -  IDS-SR score of &gt;or=26 at baseline&#xD;
&#xD;
          -  No filling of antidepressant medication prescription for 270 prior days&#xD;
&#xD;
          -  Illiteracy or the lack of working telephone to receive reminders.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of alcohol or substance dependence&#xD;
&#xD;
          -  History of Bipolar Disorder determined by a baseline Composite International&#xD;
             Diagnostic Interview (CIDI) screening scale of lifetime mania/hypomania&#xD;
&#xD;
          -  Any current prescription for mood stabilizer or antipsychotic medication&#xD;
&#xD;
          -  Female with positive pregnancy test&#xD;
&#xD;
          -  General medical conditions which contraindicate antidepressant medications&#xD;
&#xD;
          -  Clinical status requiring inpatient or day hospital treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matteo Balestrieri, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Centro San Giovanni di Dio Fatebenefratelli</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Telematic Network srl</name>
      <address>
        <city>Brescia</city>
        <zip>25125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Centro San Giovanni di Dio Fatebenefratelli</name>
      <address>
        <city>Brescia</city>
        <zip>25125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dipartimento di Scienze Mediche Sperimentali e Cliniche, Università di Udine</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marco B. Rocchi</name>
      <address>
        <city>Urbino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.irccs-fatebenefratelli.it/</url>
    <description>Website of the Coordinating Centre</description>
  </link>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>February 23, 2016</last_update_submitted>
  <last_update_submitted_qc>February 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Centro San Giovanni di Dio Fatebenefratelli</investigator_affiliation>
    <investigator_full_name>Giovanni de Girolamo, M.D.</investigator_full_name>
    <investigator_title>Scientific Director</investigator_title>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Primary care</keyword>
  <keyword>Computerized decision support system</keyword>
  <keyword>General practitioner</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01701791
org study id: RF-2010-2316063
nct id: NCT01701791
lead sponsor: 
has dmc: Yes
Background: In Italy, several recent studies found that a large percentage of patients
      attending Primary Care (PC) clinics meet criteria for at least one common mental disorder, as
      they show high rates of depression, anxiety, and co-morbid anxiety and depression. These
      patients may experience significant functional impairment and suffer from unexplained somatic
      symptoms, and often remain undetected and untreated. Consistent evidence for the
      effectiveness of organized care programs for depression, by improving quality of care and
      treatment adherence, is now available. Fundamental elements of these programs include
      algorithms to prompt the proper and timely implementation of evidence-based treatments,
      structured outcome assessment and systematic outreach. Telemedicine tools may represent a
      valuable strategy for improving depression outcomes in PC.

      Aims: 1.To develop and employ computer-based assessment to more accurately and timely detect
      patient depression in PC settings; 2.To evaluate the feasibility and effectiveness of a care
      support program developed in conjunction with the PC-based assessment for patients suffering
      from depression, as based on two main objectives: 2a.To support GP decisions with treatment
      algorithms and improve the quality of GP and mental health service collaboration; 2b.To
      improve patient compliance and treatment adherence by using appropriate telecommunication
      tools and technologically advanced tools to conduct systematic routine assessment. Although
      much of this system will be computer-based, live telephonic and in-person contacts will also
      be included as needed.

      Study Design: The study is a randomized controlled trial, involving four PC group clinics
      (GCs) located in two areas of Northern Italy. Two PC clinics will use the experimental
      protocol; the other two will serve as controls.

      The study will compare two different conditions:

        -  Group 1 (experimental): GPs will use a Computer Decision Support System with treatment
           algorithms and advice and supervision from a consultant psychiatrist. Patients will
           receive reminders via mobile texting or automatic mobile (or landline) phone calls to
           improve adherence to the treatment prescribed.

        -  Group 2 (control): GPs will provide TAU, will make their own decisions and will
           therefore not use the CDSS. Patients will not receive any reminders. All enrolled
           patients will be administered and will fill in the IDS-SR at baseline, 3 and 6-months:
           the IDS-SR score will be used as a primary endpoint.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Proportion of patients reaching remission
time frame: 6 months
description: The primary end-point will be the proportion of patients reaching remission by 6 months, as represented by an exit IDS-SR score of <or=12.
measure: Number of GP appointments actually attended during follow-up
time frame: 6 months
arm group label: Computerized Decision Support System (CDSS)
arm group type: Experimental
description: GPs will use a CDSS with treatment algorithms, supervision from a consultant psychiatrist, and despatch to patients of reminders via mobile texting or automatic mobile (or landline) phone calls to improve adherence to the treatment prescribed.
arm group label: Treatment as usual
arm group type: No Intervention
description: GPs will provide TAU, will make their own decisions and will therefore not use the CDSS. Patients will not receive any reminders.
intervention type: Other
intervention name: Computerized Decision Support System
arm group label: Computerized Decision Support System (CDSS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Matteo Balestrieri, M.D.
role: Principal Investigator
affiliation: IRCCS Centro San Giovanni di Dio Fatebenefratelli
facility: 
facility: 
facility: 
facility: 
country: Italy
url: http://www.irccs-fatebenefratelli.it/
description: Website of the Coordinating Centre
responsible party type: Principal Investigator
investigator affiliation: IRCCS Centro San Giovanni di Dio Fatebenefratelli
investigator full name: Giovanni de Girolamo, M.D.
investigator title: Scientific Director
mesh term: Depression
mesh term: Depressive Disorder