<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/NCT03043040</url>
  </required_header>
  <id_info>
    <org_study_id>2017AG01</org_study_id>
    <nct_id>NCT03043040</nct_id>
  </id_info>
  <brief_title>Prevention of Suicidal Behaviour With Telemedicine Techniques</brief_title>
  <official_title>Prevention of Suicidal Behaviour in High Risk Patients With Telemedicine Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osakidetza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eusko Jaurlaritza</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Osakidetza</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 multicenter controlled intervention study that aims to assess the efficacy of a&#xD;
      telephone follow-up program for the prevention of suicidal behavior in adults discharged from&#xD;
      general hospitals after a suicide attempt.&#xD;
&#xD;
      The hypothesis is that the implementation of this program is associated with reduced rates of&#xD;
      suicide reattempts in these patients and also with delayed reattempts in them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Justification: Suicide is a global public health concern and is the leading cause of&#xD;
      avoidable death in the Basque Country (Spain). The use of telemedicine techniques applied to&#xD;
      high risk patients has shown to be useful in the prevention of suicide and suicidal behavior.&#xD;
&#xD;
      Objectives: To assess the efficacy of a telephone follow-up program for the prevention of&#xD;
      suicidal behavior in patients who recently attempted suicide.&#xD;
&#xD;
      Design: This is a multicenter, prospective intervention study, non-randomized and with&#xD;
      control group.&#xD;
&#xD;
      Method: A sample of adults discharged from 2 general hospitals after a suicide attempt are&#xD;
      enrolled in a telephone follow-up program which is added to their usual treatment (TAU). The&#xD;
      program consists of 5 short calls made by nurses during 6 months. The calls are intended to:&#xD;
      1) Assess the risk of suicide in that moment, 2) Improve patient's adherence to treatments,&#xD;
      and 3) Provide general psychoeducation guidelines. The control group is composed of patients&#xD;
      discharged from a third general hospital after a suicide attempt. These receive TAU but are&#xD;
      not enrolled in the telephone follow-up.&#xD;
&#xD;
      Evaluation: All patients are followed during 12 months. Main outcome measures include the&#xD;
      percentage of patients that make a second attempt and the average time to reattempt.&#xD;
&#xD;
      Patients sign and informed consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a non-randomized non-blinded multicenter intervention study with control group. Patients from hospital A and B are included in the intervention group. Patients from hospital C are included in the control group.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants in each group that make a second attempt</measure>
    <time_frame>0-12 months</time_frame>
    <description>(Included in the title)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average number of days from the first attempt to the second, in each group</measure>
    <time_frame>0-12 months</time_frame>
    <description>(Included in the title)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of reattempts in each group</measure>
    <time_frame>0-12 months</time_frame>
    <description>(Included in the title)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in each group requiring hospitalization after the suicide attempt</measure>
    <time_frame>0-12 months</time_frame>
    <description>(Included in the title)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">651</enrollment>
  <condition>Suicide, Attempted</condition>
  <arm_group>
    <arm_group_label>Telephone follow up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients discharged from hospital A and B after a suicide attempt receive a protocolized telephone follow which is added to their usual treatment (TAU). Calls are made by nurses at weeks 1,2,4,12 and 24 after the index suicide attempt.&#xD;
TAU: Includes whatever treatment the doctor decides to offer to that patient (psychopharmacology, psychotherapy etc).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients discharged from hospital C after a suicide attempt receive treatment as usual (whatever treatment the doctor decides to offer to that patient: psychopharmacology, psychotherapy etc).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone follow up</intervention_name>
    <description>Already described in previous page</description>
    <arm_group_label>Telephone follow up</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>Already described in previous page</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Telephone follow up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients discharged from a General Hospital after a suicide attempt and who live&#xD;
             in the same health sector as the hospital.&#xD;
&#xD;
          -  The suicide attempt must have been made within 24 hours prior to the appointment in&#xD;
             the Emergency Service.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with severe cognitive difficulties and in general any self-injury in which the&#xD;
             patient does not understand the meaning or potential consequences of such behavior.&#xD;
&#xD;
          -  Patients in which a regular telephone contact is not possible.&#xD;
&#xD;
          -  Patients in which the psychiatrist who evaluates the case deems inappropriate their&#xD;
             inclusion.&#xD;
&#xD;
          -  Patients who remain hospitalized 6 months after the attempt.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>April 6, 2018</last_update_submitted>
  <last_update_submitted_qc>April 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Osakidetza</investigator_affiliation>
    <investigator_full_name>Andrea Gabilondo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>suicide, attempted</keyword>
  <keyword>prevention</keyword>
  <keyword>telemedicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicide, Attempted</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/NCT03043040
org study id: 2017AG01
nct id: NCT03043040
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multicenter controlled intervention study that aims to assess the efficacy of a
      telephone follow-up program for the prevention of suicidal behavior in adults discharged from
      general hospitals after a suicide attempt.

      The hypothesis is that the implementation of this program is associated with reduced rates of
      suicide reattempts in these patients and also with delayed reattempts in them.
Justification: Suicide is a global public health concern and is the leading cause of
      avoidable death in the Basque Country (Spain). The use of telemedicine techniques applied to
      high risk patients has shown to be useful in the prevention of suicide and suicidal behavior.

      Objectives: To assess the efficacy of a telephone follow-up program for the prevention of
      suicidal behavior in patients who recently attempted suicide.

      Design: This is a multicenter, prospective intervention study, non-randomized and with
      control group.

      Method: A sample of adults discharged from 2 general hospitals after a suicide attempt are
      enrolled in a telephone follow-up program which is added to their usual treatment (TAU). The
      program consists of 5 short calls made by nurses during 6 months. The calls are intended to:
      1) Assess the risk of suicide in that moment, 2) Improve patient's adherence to treatments,
      and 3) Provide general psychoeducation guidelines. The control group is composed of patients
      discharged from a third general hospital after a suicide attempt. These receive TAU but are
      not enrolled in the telephone follow-up.

      Evaluation: All patients are followed during 12 months. Main outcome measures include the
      percentage of patients that make a second attempt and the average time to reattempt.

      Patients sign and informed consent.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is a non-randomized non-blinded multicenter intervention study with control group. Patients from hospital A and B are included in the intervention group. Patients from hospital C are included in the control group.
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of participants in each group that make a second attempt
time frame: 0-12 months
description: (Included in the title)
measure: Average number of days from the first attempt to the second, in each group
time frame: 0-12 months
description: (Included in the title)
measure: Mean number of reattempts in each group
time frame: 0-12 months
description: (Included in the title)
measure: Percentage of participants in each group requiring hospitalization after the suicide attempt
time frame: 0-12 months
description: (Included in the title)
arm group label: Telephone follow up
arm group type: Experimental
description: Patients discharged from hospital A and B after a suicide attempt receive a protocolized telephone follow which is added to their usual treatment (TAU). Calls are made by nurses at weeks 1,2,4,12 and 24 after the index suicide attempt.
TAU: Includes whatever treatment the doctor decides to offer to that patient (psychopharmacology, psychotherapy etc).
arm group label: Control
arm group type: Active Comparator
description: Patients discharged from hospital C after a suicide attempt receive treatment as usual (whatever treatment the doctor decides to offer to that patient: psychopharmacology, psychotherapy etc).
intervention type: Behavioral
intervention name: Telephone follow up
description: Already described in previous page
arm group label: Telephone follow up
intervention type: Behavioral
intervention name: Treatment as usual
description: Already described in previous page
arm group label: Control
arm group label: Telephone follow up
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Osakidetza
investigator full name: Andrea Gabilondo
investigator title: Principal Investigator
mesh term: Suicide
mesh term: Suicide, Attempted
sharing ipd: No