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/NCT05966077</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A01404-39</org_study_id>
      <secondary_id>RIPH-2022-02</secondary_id>
      <nct_id>NCT05966077</nct_id>
    </id_info>
    <brief_title>Impact of Sending an Sms on the Rate of Telephone Responses of Subjects Contacted 3 Months After the Suicidal Act</brief_title>
    <acronym>EVAREST3</acronym>
    <official_title>Impact of Sending an Sms in the &quot;Vigilans Lorraine&quot; Monitoring System on the Rate of Telephone Responses of Subjects Contacted 3 Months After a Passage to the Suicidal Act</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Psychothérapique de Nancy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Groupement Interrégional de Recherche Clinique et d'Innovation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre Psychothérapique de Nancy</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>
        The objective of this controlled, randomized, monocentric study is to compare the response&#xD;
        rate of the call at 3 months of the groups with or without short message service (SMS) 48&#xD;
        hours before, for the subjects having benefited from the device &quot;VigilanS Lorraine&quot;. The&#xD;
        secondary objectives will be to appreciate the satisfaction of the subjects towards the&#xD;
        sending of the SMS as well as to compare the delay of suicidal recidivism according to&#xD;
        whether the subjects answered or not to the call of evaluation at 3 months of the passage to&#xD;
        the act The main question it aims to answer is: What impact, on the rate of successful calls,&#xD;
        could sending a text message 48 hours before the 3-month evaluation phone call have on&#xD;
        subjects benefiting from the VigilanS device?&#xD;
  &#xD;
        The participants will be divided into 2 groups:&#xD;
  &#xD;
          -  1st group: SMS sent 48 hours before the 3-month evaluation call planned in the framework&#xD;
             of the &quot;VigilanS Lorraine&quot; program.&#xD;
  &#xD;
          -  2nd group (control): evaluation call at 3 months planned within the framework of the&#xD;
             &quot;VigilanS Lorraine&quot; system, not preceded by an SMS 48 hours before.&#xD;
  &#xD;
        The desired effect was an increase in the percentage of successful calls at 3 months,&#xD;
        allowing for possible evaluations at 3 months in order to identify, evaluate and accompany&#xD;
        subjects still in a suicidal crisis and thus avoid a recurrence of the act and thus a&#xD;
        suicide.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>
      <intervention_model_description>Randomized controlled trials</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of successful calls during the 3 month evaluation</measure>
      <time_frame>3 months</time_frame>
      <description>. A call is considered unsuccessful after 3 call attempts at 3 different times over 3 consecutive working days.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SMS delivery status:</measure>
      <time_frame>3 months</time_frame>
      <description>issued/not issued</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction survey</measure>
      <time_frame>3 months</time_frame>
      <description>subjective experience of the subject having benefited from the sending of the SMS in relation to the intervention, the delay between the sending of the SMS and the telephone call</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Suicide, Attempted</condition>
    <arm_group>
      <arm_group_label>SMS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Without SMS</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>without Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>IMPACT OF SENDING AN SMS</intervention_name>
      <description>Each subject of the experimental group will receive, in addition to the usual procedure of the VigilanS Lorraine device, an SMS 48 hours before the telephone call for evaluation at 3 months, warning him of this call.&#xD;
  The time of this SMS has been set at 1:00 p.m. for all the people included in this group.&#xD;
  At the end of this evaluation call, the caller will pass a satisfaction questionnaire to the subject in relation to the sending of the SMS</description>
      <arm_group_label>SMS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having made a suicide attempt (first-time suicide or not)&#xD;
  &#xD;
            -  Hosted at the Central Hospital of Nancy&#xD;
  &#xD;
            -  Included in the &quot;VigilanS Lorraine&quot; monitoring system&#xD;
  &#xD;
            -  Not presenting criteria for non-inclusion in the &quot;VigilanS Lorraine&quot; system, namely:&#xD;
  &#xD;
                 -  Guardianship&#xD;
  &#xD;
                 -  Held&#xD;
  &#xD;
                 -  Dementia&#xD;
  &#xD;
                 -  Not speaking French&#xD;
  &#xD;
            -  Subject having received information relating to the progress of the EVAREST 3 study&#xD;
               and having given their consent to participate&#xD;
  &#xD;
            -  Subject affiliated or entitled to a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject without mobile phone&#xD;
  &#xD;
            -  Participation in another interventional study on the prevention of suicidal recidivism&#xD;
  &#xD;
            -  Subject under curatorship who was not assisted by his curator to give his consent to&#xD;
               participate&#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>Xavier SIPP, Mr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre Psychothérapique de Nancy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xavier SIPP</last_name>
      <phone>03.83.85.16.58</phone>
      <phone_ext>0033</phone_ext>
      <email>xavier.sipp@cpn-laxou.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Naoual MELLOUKI BENDIM'RED, PhD</last_name>
      <phone>0383925267</phone>
      <phone_ext>0033</phone_ext>
      <email>unic@cpn-laxou.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 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 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>suicide attempt prevention standby device</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>
  
  
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/NCT05966077
  org study id: 2022-A01404-39
  secondary id: RIPH-2022-02
  nct id: NCT05966077
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this controlled, randomized, monocentric study is to compare the response
        rate of the call at 3 months of the groups with or without short message service (SMS) 48
        hours before, for the subjects having benefited from the device "VigilanS Lorraine". The
        secondary objectives will be to appreciate the satisfaction of the subjects towards the
        sending of the SMS as well as to compare the delay of suicidal recidivism according to
        whether the subjects answered or not to the call of evaluation at 3 months of the passage to
        the act The main question it aims to answer is: What impact, on the rate of successful calls,
        could sending a text message 48 hours before the 3-month evaluation phone call have on
        subjects benefiting from the VigilanS device?
  
        The participants will be divided into 2 groups:
  
          -  1st group: SMS sent 48 hours before the 3-month evaluation call planned in the framework
             of the "VigilanS Lorraine" program.
  
          -  2nd group (control): evaluation call at 3 months planned within the framework of the
             "VigilanS Lorraine" system, not preceded by an SMS 48 hours before.
  
        The desired effect was an increase in the percentage of successful calls at 3 months,
        allowing for possible evaluations at 3 months in order to identify, evaluate and accompany
        subjects still in a suicidal crisis and thus avoid a recurrence of the act and thus a
        suicide.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trials
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Percentage of successful calls during the 3 month evaluation
  time frame: 3 months
  description: . A call is considered unsuccessful after 3 call attempts at 3 different times over 3 consecutive working days.
  measure: SMS delivery status:
  time frame: 3 months
  description: issued/not issued
  measure: Satisfaction survey
  time frame: 3 months
  description: subjective experience of the subject having benefited from the sending of the SMS in relation to the intervention, the delay between the sending of the SMS and the telephone call
  arm group label: SMS
  arm group type: Experimental
  description: Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system
  arm group label: Without SMS
  arm group type: No Intervention
  description: without Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system
  intervention type: Other
  intervention name: IMPACT OF SENDING AN SMS
  description: Each subject of the experimental group will receive, in addition to the usual procedure of the VigilanS Lorraine device, an SMS 48 hours before the telephone call for evaluation at 3 months, warning him of this call.
  The time of this SMS has been set at 1:00 p.m. for all the people included in this group.
  At the end of this evaluation call, the caller will pass a satisfaction questionnaire to the subject in relation to the sending of the SMS
  arm group label: SMS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xavier SIPP, Mr.
  role: Principal Investigator
  affiliation: Centre Psychothérapique de Nancy
  last name: Xavier SIPP
  phone: 03.83.85.16.58
  phone ext: 0033
  email: xavier.sipp@cpn-laxou.com
  last name: Naoual MELLOUKI BENDIM'RED, PhD
  phone: 0383925267
  phone ext: 0033
  email: unic@cpn-laxou.com
  responsible party type: Sponsor
  mesh term: Suicide
  mesh term: Suicide, Attempted
  sharing ipd: No