<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/NCT04417374</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0320</org_study_id>
    <nct_id>NCT04417374</nct_id>
  </id_info>
  <brief_title>Caracteristics of the Patients Hospitalized With Unvonluntary Commitment Procedure, in the Context COVID-19</brief_title>
  <acronym>HoCoPsy</acronym>
  <official_title>Caracteristics of the Patients Hospitalized With Unvonluntary Commitment Procedure, in Pandemic and Confinement Context</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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 actual worldwide context (disease outbreak, confinements instaured in many countries) is&#xD;
      a stressful factor for many people. It can have consequences on mental health : separation&#xD;
      from loved ones, loss of freedom, uncertainty about infection status, boredom. Patients with&#xD;
      mental disorders are especially vulnerable.&#xD;
&#xD;
      On march 17th, the french government ordonned a national confinement to slow the progression&#xD;
      of the COVID-19 outbreak, for 15 days at first then renewed several times. This situation has&#xD;
      led to a reorganization of care as requested on March 22nd, 2020 in the recommendations&#xD;
      applicable to the organization of care in psychiatric services : priority to telephone&#xD;
      contacts and teleconsultation by multiplying contacts and assessments.&#xD;
&#xD;
      By the time the reorganization of care became operational, the most vulnerable patients may&#xD;
      have experienced a decompensation of their disease.&#xD;
&#xD;
      It is important to know if the COVID-19 outbreak combined with the confinement increased the&#xD;
      number of unvoluntary commitment the month after the announce of the confinement.&#xD;
&#xD;
      This could help us understand which patients are more vulnerable is this context, and improve&#xD;
      our organization (ambulatory and hospitalization care) if this situation occurs again.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective is to notice if we can observe a increase in the number of unvonluntary&#xD;
      commitment the month after the announce of the confinement in the psychiatric hospital La&#xD;
      Colombière, CHU Montpellier, France.&#xD;
&#xD;
      Secondary objectives :&#xD;
&#xD;
        -  Describe the causes of unvonluntary commitment, and the principal psychiatric diagnostic&#xD;
           of the patients&#xD;
&#xD;
        -  Assess the lengh of the hospitalization&#xD;
&#xD;
        -  Assess the number of patients hospitalized without psychiatric antecedent&#xD;
&#xD;
        -  Assess the number of treatment interruptions in the recent history before&#xD;
           hospitalization&#xD;
&#xD;
        -  Asses the number of patients living alone&#xD;
&#xD;
        -  Asses the number of patients using drugs&#xD;
&#xD;
      It is expected to highlight :&#xD;
&#xD;
        -  An increase of the number of unvontuntary commitment&#xD;
&#xD;
        -  If one or several mental disorders were more at risk of requiring an unvonluntary&#xD;
           commitment&#xD;
&#xD;
        -  An increased lengh of hospitalization&#xD;
&#xD;
        -  An increased number of unvonluntary commitment of patients without psychiatric&#xD;
           antecedent&#xD;
&#xD;
        -  An increased number of treatment interruptions&#xD;
&#xD;
        -  A link between hospitalization and living alone&#xD;
&#xD;
        -  A link between hospitalization and using drugs&#xD;
&#xD;
      The medical file of all the patients unvonlutary commited from march 12th to April 09th 2020&#xD;
      are screened, and compared to the patients unvonlutary commited during the same period in&#xD;
      2019.&#xD;
&#xD;
      The caracteristics of interest are their age and sex, if the patient lives alone, the matter&#xD;
      of hospitalization, its lengh, their primary psychiatric diagnostic, the use of toxics at the&#xD;
      moment of the hospitalization and if this psychiatric decompensation happens in a context of&#xD;
      treatment interruption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of hospitalized patients</measure>
    <time_frame>1 months</time_frame>
    <description>Number of hospitalized patients From March 12th to April 09th</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cause of hospitalization</measure>
    <time_frame>1 months</time_frame>
    <description>Primary psychiatric diagnostic From March 12th to April 09th</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Lengh of hospitalization</measure>
    <time_frame>1 months</time_frame>
    <description>Patients without psychiatric antecedent (number) From March 12th to April 09th</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment interruption</measure>
    <time_frame>1 months</time_frame>
    <description>Presence of absence of history of treatment interruption leading to the hospitalization From March 12th to April 09th</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of hospitalized patients living alone</measure>
    <time_frame>1 months</time_frame>
    <description>Number of hospitalized patients living alone (opposed to those living with family) From March 12th to April 09th</description>
  </other_outcome>
  <other_outcome>
    <measure>Use of drugs</measure>
    <time_frame>1 months</time_frame>
    <description>Number of patients using drugs From March 12th to April 09th</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">94</enrollment>
  <condition>COVID 19</condition>
  <condition>Disease Outbreak</condition>
  <condition>Mental Disorders</condition>
  <arm_group>
    <arm_group_label>Unvonluntary commitment from March 12th to April 09th 2019</arm_group_label>
    <description>Patients hospitalized with unvonluntary commitment procedure from March 12th to April 09th 2019</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unvonluntary commitment from March 12th to April 09th 2020</arm_group_label>
    <description>Patients hospitalized with unvonluntary commitment procedure from March 12th to April 09th 2020</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Description of groups caracteristics</intervention_name>
    <description>Comparison of the two groups on all the following criterias : age, sex, if the patient lives alone, the matter of hospitalization, its lengh, their primary psychiatric diagnostic, the use of toxics at the moment of the hospitalization and if this psychiatric decompensation happens in a context of treatment interruption.</description>
    <arm_group_label>Unvonluntary commitment from March 12th to April 09th 2019</arm_group_label>
    <arm_group_label>Unvonluntary commitment from March 12th to April 09th 2020</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults having been aditted to the psychiatric hospital La Colombière, CHU Montpellier,&#xD;
        France, with unvonluntary commitment procedure from march 12th to April 09th (2019 and&#xD;
        2020)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Unvonluntary commitment in psychiatric hospital La Colombière, CHU Montpellier, from&#xD;
        march 12th to april 19th (2019 and 2020).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - refusal to 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>Emilie Olie, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Confinement</keyword>
  <keyword>Disease outbreak</keyword>
  <keyword>Unvonluntary commitment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04417374
org study id: RECHMPL20_0320
nct id: NCT04417374
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The actual worldwide context (disease outbreak, confinements instaured in many countries) is
      a stressful factor for many people. It can have consequences on mental health : separation
      from loved ones, loss of freedom, uncertainty about infection status, boredom. Patients with
      mental disorders are especially vulnerable.

      On march 17th, the french government ordonned a national confinement to slow the progression
      of the COVID-19 outbreak, for 15 days at first then renewed several times. This situation has
      led to a reorganization of care as requested on March 22nd, 2020 in the recommendations
      applicable to the organization of care in psychiatric services : priority to telephone
      contacts and teleconsultation by multiplying contacts and assessments.

      By the time the reorganization of care became operational, the most vulnerable patients may
      have experienced a decompensation of their disease.

      It is important to know if the COVID-19 outbreak combined with the confinement increased the
      number of unvoluntary commitment the month after the announce of the confinement.

      This could help us understand which patients are more vulnerable is this context, and improve
      our organization (ambulatory and hospitalization care) if this situation occurs again.
The main objective is to notice if we can observe a increase in the number of unvonluntary
      commitment the month after the announce of the confinement in the psychiatric hospital La
      Colombière, CHU Montpellier, France.

      Secondary objectives :

        -  Describe the causes of unvonluntary commitment, and the principal psychiatric diagnostic
           of the patients

        -  Assess the lengh of the hospitalization

        -  Assess the number of patients hospitalized without psychiatric antecedent

        -  Assess the number of treatment interruptions in the recent history before
           hospitalization

        -  Asses the number of patients living alone

        -  Asses the number of patients using drugs

      It is expected to highlight :

        -  An increase of the number of unvontuntary commitment

        -  If one or several mental disorders were more at risk of requiring an unvonluntary
           commitment

        -  An increased lengh of hospitalization

        -  An increased number of unvonluntary commitment of patients without psychiatric
           antecedent

        -  An increased number of treatment interruptions

        -  A link between hospitalization and living alone

        -  A link between hospitalization and using drugs

      The medical file of all the patients unvonlutary commited from march 12th to April 09th 2020
      are screened, and compared to the patients unvonlutary commited during the same period in
      2019.

      The caracteristics of interest are their age and sex, if the patient lives alone, the matter
      of hospitalization, its lengh, their primary psychiatric diagnostic, the use of toxics at the
      moment of the hospitalization and if this psychiatric decompensation happens in a context of
      treatment interruption.
observational model: Cohort
time perspective: Prospective
measure: Number of hospitalized patients
time frame: 1 months
description: Number of hospitalized patients From March 12th to April 09th
measure: Cause of hospitalization
time frame: 1 months
description: Primary psychiatric diagnostic From March 12th to April 09th
measure: Lengh of hospitalization
time frame: 1 months
description: Patients without psychiatric antecedent (number) From March 12th to April 09th
measure: Treatment interruption
time frame: 1 months
description: Presence of absence of history of treatment interruption leading to the hospitalization From March 12th to April 09th
measure: Number of hospitalized patients living alone
time frame: 1 months
description: Number of hospitalized patients living alone (opposed to those living with family) From March 12th to April 09th
measure: Use of drugs
time frame: 1 months
description: Number of patients using drugs From March 12th to April 09th
arm group label: Unvonluntary commitment from March 12th to April 09th 2019
description: Patients hospitalized with unvonluntary commitment procedure from March 12th to April 09th 2019
arm group label: Unvonluntary commitment from March 12th to April 09th 2020
description: Patients hospitalized with unvonluntary commitment procedure from March 12th to April 09th 2020
intervention type: Other
intervention name: Description of groups caracteristics
description: Comparison of the two groups on all the following criterias : age, sex, if the patient lives alone, the matter of hospitalization, its lengh, their primary psychiatric diagnostic, the use of toxics at the moment of the hospitalization and if this psychiatric decompensation happens in a context of treatment interruption.
arm group label: Unvonluntary commitment from March 12th to April 09th 2019
arm group label: Unvonluntary commitment from March 12th to April 09th 2020
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emilie Olie, MD PhD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Mental Disorders
sharing ipd: Undecided
ipd description: NC