<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/NCT04460196</url>
  </required_header>
  <id_info>
    <org_study_id>49RC20_0155</org_study_id>
    <nct_id>NCT04460196</nct_id>
  </id_info>
  <brief_title>Healthcare Renunciation During the Confinement Period in Connection With the COVID-19 Epidemic in Adult Emergency Departments</brief_title>
  <official_title>Healthcare Renunciation During the Confinement Period in Connection With the COVID-19 Epidemic in Adult Emergency Departments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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>
      Healthcare renunciation is defined as: &quot;Individuals give up care when they do not seek&#xD;
      services and health care professionals when they experience a disorder, experience a physical&#xD;
      or mental disorder, or when they do not access all of the prescribed care.&quot; In 2008, 16.5% of&#xD;
      the general French population reported having renounced care. The causes mentioned of the&#xD;
      renunciation are mainly the financial difficulties, the deadlines of appointments considered&#xD;
      too long, the geographical remoteness. In the department of Sarthe, the rate of cessation of&#xD;
      care is estimated at 27.6% over the period from 2014 to 2017.&#xD;
&#xD;
      In the context of the COVID-19 epidemic, containment was applied in France counted from 17&#xD;
      March 2020. The widespread message was &quot;save lives, stay at home&quot;. The Ministry of Solidarity&#xD;
      and Health has provided health professionals with a circular to adapt the management of&#xD;
      patients with chronic disease, requiring elective surgical care and pregnant women.&#xD;
&#xD;
      The decline in activity of general practitioners is estimated at 44% and that of other&#xD;
      specialists at 71%. In Paris, visits to the emergency room fell by 45% for adults and 70% for&#xD;
      children.&#xD;
&#xD;
      The main risk is the deterioration of the health status of some patients with the worsening&#xD;
      of chronic diseases, the discovery of pathologies during episodes of decompensation and the&#xD;
      absence of management of serious acute pathologies.&#xD;
&#xD;
      The study aims to assess the importance of giving up care during this period of COVID-19 and&#xD;
      in comparison with a study conducted at the University Hospital of Angers and the hospital of&#xD;
      Le Mans in 2017.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Actual">September 18, 2020</completion_date>
  <primary_completion_date type="Actual">September 18, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>rate of patients who gave up consulting in the emergency department</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <enrollment type="Actual">900</enrollment>
  <condition>Emergency Medicine</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>survey</intervention_name>
    <description>Each admitted patient will complete a questionnaire</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Person unable to give a non-opposition&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adults patients consulting in the emergency department and agreeing to answer the&#xD;
             questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient admitted in the emergency department in serious condition (life distress)&#xD;
&#xD;
          -  Person unable to consent&#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>CHU Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Le Mans</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 22, 2020</last_update_submitted>
  <last_update_submitted_qc>September 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</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/NCT04460196
org study id: 49RC20_0155
nct id: NCT04460196
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Healthcare renunciation is defined as: "Individuals give up care when they do not seek
      services and health care professionals when they experience a disorder, experience a physical
      or mental disorder, or when they do not access all of the prescribed care." In 2008, 16.5% of
      the general French population reported having renounced care. The causes mentioned of the
      renunciation are mainly the financial difficulties, the deadlines of appointments considered
      too long, the geographical remoteness. In the department of Sarthe, the rate of cessation of
      care is estimated at 27.6% over the period from 2014 to 2017.

      In the context of the COVID-19 epidemic, containment was applied in France counted from 17
      March 2020. The widespread message was "save lives, stay at home". The Ministry of Solidarity
      and Health has provided health professionals with a circular to adapt the management of
      patients with chronic disease, requiring elective surgical care and pregnant women.

      The decline in activity of general practitioners is estimated at 44% and that of other
      specialists at 71%. In Paris, visits to the emergency room fell by 45% for adults and 70% for
      children.

      The main risk is the deterioration of the health status of some patients with the worsening
      of chronic diseases, the discovery of pathologies during episodes of decompensation and the
      absence of management of serious acute pathologies.

      The study aims to assess the importance of giving up care during this period of COVID-19 and
      in comparison with a study conducted at the University Hospital of Angers and the hospital of
      Le Mans in 2017.
observational model: Cohort
time perspective: Prospective
measure: rate of patients who gave up consulting in the emergency department
time frame: 1 day
intervention type: Other
intervention name: survey
description: Each admitted patient will complete a questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Emergencies