<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/NCT04432922</url>
  </required_header>
  <id_info>
    <org_study_id>ISOCOV</org_study_id>
    <nct_id>NCT04432922</nct_id>
  </id_info>
  <brief_title>Perceptions, Representations and Experiences of Septic Isolation of Hospitalized Patients for COVID-19 Infection</brief_title>
  <official_title>Perceptions, Representations and Experiences of Septic Isolation of Hospitalized</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</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 aim of this study is to analyze the perceptions, representations and experiences of&#xD;
      septic isolation of patients hospitalized for COVID-19 infection.&#xD;
&#xD;
      This analysis could lead to better understanding and communication between the medical&#xD;
      profession and patients in septic isolation in hospital. It would also provide&#xD;
      patient-specific responses to their expectations, as to their families.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SARS-Cov2 is a new virus responsible for the COVID-19 pandemic. For the first time, it was&#xD;
      observed in Wuhan, China in December 2019. For this previously unknown contagious disease,&#xD;
      which can cause severe respiratory infections, isolation precautions in hospitals and public&#xD;
      places are one of the cornerstones for fighting this pandemic.&#xD;
&#xD;
      Hospital isolation precautions have been present since the 19th century as a means to control&#xD;
      the spread of infections. Septic isolation includes contact isolation, droplets and air.&#xD;
      Isolation precautions must be prescribed by a physician. To our knowledge, there are few&#xD;
      studies about the impact of septic isolation on hospitalized patients at both the&#xD;
      psychological level and the relationship with doctors.&#xD;
&#xD;
      This study could enable a better understanding and communication between the medical&#xD;
      profession and patients in septic isolation during hospitalization. It could also provide&#xD;
      patient-specific responses to their expectations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">November 15, 2020</completion_date>
  <primary_completion_date type="Actual">November 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To highlight the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>to identify key elements to improve the medical discourse on septic isolation among patients</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>COVID19</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hospitalized Patients for COVID-19 Infection</intervention_name>
    <description>Face to face semi-directed interviews about perceptions, representations and experiences of septic isolation, including nine opened-questions.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be provided to Covid 19 participants during their hospitalization or upon&#xD;
        discharge from hospitalization&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patients&#xD;
&#xD;
          -  Living in metropolitan France during the SARS-CoV2 pandemic&#xD;
&#xD;
          -  Being or having been hospitalized in isolation contact and droplet for a COVID-19&#xD;
             infection (proven or suspected)&#xD;
&#xD;
          -  Being in the process of leaving hospital&#xD;
&#xD;
          -  Ready for No Opposition for Participation in the Protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under guardianship or curatorship&#xD;
&#xD;
          -  Patients unable to give free and informed consent;&#xD;
&#xD;
          -  Patients under safeguarding justice&#xD;
&#xD;
          -  Hospitalized patients on oxygen therapy with speech dyspnea&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre hospitalier intercommunal de Villeneuve St Georges</name>
      <address>
        <city>Villeneuve St Georges</city>
        <zip>94190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Septic isolation, perception, questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04432922
org study id: ISOCOV
nct id: NCT04432922
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to analyze the perceptions, representations and experiences of
      septic isolation of patients hospitalized for COVID-19 infection.

      This analysis could lead to better understanding and communication between the medical
      profession and patients in septic isolation in hospital. It would also provide
      patient-specific responses to their expectations, as to their families.
SARS-Cov2 is a new virus responsible for the COVID-19 pandemic. For the first time, it was
      observed in Wuhan, China in December 2019. For this previously unknown contagious disease,
      which can cause severe respiratory infections, isolation precautions in hospitals and public
      places are one of the cornerstones for fighting this pandemic.

      Hospital isolation precautions have been present since the 19th century as a means to control
      the spread of infections. Septic isolation includes contact isolation, droplets and air.
      Isolation precautions must be prescribed by a physician. To our knowledge, there are few
      studies about the impact of septic isolation on hospitalized patients at both the
      psychological level and the relationship with doctors.

      This study could enable a better understanding and communication between the medical
      profession and patients in septic isolation during hospitalization. It could also provide
      patient-specific responses to their expectations.
observational model: Other
time perspective: Prospective
measure: To highlight the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection
time frame: 1 day
measure: to identify key elements to improve the medical discourse on septic isolation among patients
time frame: 1 day
intervention type: Other
intervention name: Hospitalized Patients for COVID-19 Infection
description: Face to face semi-directed interviews about perceptions, representations and experiences of septic isolation, including nine opened-questions.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No