<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/NCT04497246</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-COVIDIMPACT</org_study_id>
    <nct_id>NCT04497246</nct_id>
  </id_info>
  <brief_title>Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)</brief_title>
  <official_title>Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Murielle Surquin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</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>
      COVID-19 is an infectious disease caused by the last coronavirus discovered, called&#xD;
      SARS-CoV-2. Symptoms encountered in COVID-19 are: cough, breathing difficulties (dyspnea,&#xD;
      chest pain, etc.), pyrexia, anosmia (loss of smell) and/or dysgeusia (loss of taste), but&#xD;
      also ENT symptoms (rhinitis type, odynophagia), headaches, asthenia, muscle pain, confusion&#xD;
      and diarrhea. Infection with SARS-CoV-2 can also be asymptomatic. COVID-19 can be passed from&#xD;
      person to person by respiratory droplets expelled when a person speaks, coughs or sneezes.&#xD;
      The currently estimated incubation period ranges from 1 to 14 days, and most often this is&#xD;
      around 5 days.&#xD;
&#xD;
      According to a literature review, there is strong evidence that COVID-19 has an impact on&#xD;
      mental health (anxiety being the most common symptom) whether in the general population,&#xD;
      healthcare workers or vulnerable populations. The objective of this project is to assess&#xD;
      mental health and sleep disorders within two populations: elderly patients and nursing staff.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Actual">August 20, 2021</completion_date>
  <primary_completion_date type="Actual">August 20, 2021</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>Impact Event Scale-Revised (IES-R)</measure>
    <time_frame>15 minutes</time_frame>
    <description>The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events.Items are rated on a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalised Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>15 minutes</time_frame>
    <description>Self-administered patient questionnaire used as a screening tool and severity measure for generalised anxiety disorder (GAD).The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>15 minutes</time_frame>
    <description>The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insomnia severity index (ISI)</measure>
    <time_frame>15 minutes</time_frame>
    <description>The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic data</measure>
    <time_frame>1 year</time_frame>
    <description>Age, gender, familial status, home status (living alone/family support/healthcare support/ retirement home).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization duration</measure>
    <time_frame>1 year</time_frame>
    <description>Hospitalization duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>1 year</time_frame>
    <description>Hospitalization within the intensive care unit (yes/no) with or without intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical history</measure>
    <time_frame>1 year</time_frame>
    <description>History of chronic diseases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol consumption</measure>
    <time_frame>1 year</time_frame>
    <description>Alcohol consumption : none - stable - increased - diminished</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tobacco consumption</measure>
    <time_frame>1 year</time_frame>
    <description>Tobacco consumption : none - stable - increased - diminished</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1150</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Elderly patients</arm_group_label>
    <description>Elderly patients (over 65 years old) hospitalized for COVID-19 within the CHU Brugmann Hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Care professionals</arm_group_label>
    <description>Health Care professionals working within the CHU Brugmann Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Data collection by means of various questionnaires</description>
    <arm_group_label>Elderly patients</arm_group_label>
    <arm_group_label>Health Care professionals</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Subjects 65 years of age or older, having been hospitalized for COVID-19 within the&#xD;
             CHU Brugmann Hospital&#xD;
&#xD;
          -  People aged 18 or over, member of the nursing staff of the CHU Brugmann Hospital,&#xD;
             having worked during COVID-19.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects 65 years of age or older, having been hospitalized for COVID-19 within the&#xD;
             CHU Brugmann Hospital&#xD;
&#xD;
          -  People aged 18 or over, member of the nursing staff of the CHU Brugmann Hospital,&#xD;
             having worked during COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incoherent patients&#xD;
&#xD;
          -  Severe presbycusis&#xD;
&#xD;
          -  Oral expression impairment&#xD;
&#xD;
          -  Insurmountable language barrier&#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>Sophie Levy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brugmann</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Brugmann</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Murielle Surquin</investigator_full_name>
    <investigator_title>Head of geriatry department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</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/NCT04497246
org study id: CHU-COVIDIMPACT
nct id: NCT04497246
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 is an infectious disease caused by the last coronavirus discovered, called
      SARS-CoV-2. Symptoms encountered in COVID-19 are: cough, breathing difficulties (dyspnea,
      chest pain, etc.), pyrexia, anosmia (loss of smell) and/or dysgeusia (loss of taste), but
      also ENT symptoms (rhinitis type, odynophagia), headaches, asthenia, muscle pain, confusion
      and diarrhea. Infection with SARS-CoV-2 can also be asymptomatic. COVID-19 can be passed from
      person to person by respiratory droplets expelled when a person speaks, coughs or sneezes.
      The currently estimated incubation period ranges from 1 to 14 days, and most often this is
      around 5 days.

      According to a literature review, there is strong evidence that COVID-19 has an impact on
      mental health (anxiety being the most common symptom) whether in the general population,
      healthcare workers or vulnerable populations. The objective of this project is to assess
      mental health and sleep disorders within two populations: elderly patients and nursing staff.
observational model: Cohort
time perspective: Prospective
measure: Impact Event Scale-Revised (IES-R)
time frame: 15 minutes
description: The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events.Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.
measure: Generalised Anxiety Disorder-7 (GAD-7)
time frame: 15 minutes
description: Self-administered patient questionnaire used as a screening tool and severity measure for generalised anxiety disorder (GAD).The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: 15 minutes
description: The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment.
measure: Insomnia severity index (ISI)
time frame: 15 minutes
description: The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
measure: Demographic data
time frame: 1 year
description: Age, gender, familial status, home status (living alone/family support/healthcare support/ retirement home).
measure: Hospitalization duration
time frame: 1 year
description: Hospitalization duration
measure: ICU stay
time frame: 1 year
description: Hospitalization within the intensive care unit (yes/no) with or without intubation
measure: Medical history
time frame: 1 year
description: History of chronic diseases
measure: Alcohol consumption
time frame: 1 year
description: Alcohol consumption : none - stable - increased - diminished
measure: Tobacco consumption
time frame: 1 year
description: Tobacco consumption : none - stable - increased - diminished
arm group label: Elderly patients
description: Elderly patients (over 65 years old) hospitalized for COVID-19 within the CHU Brugmann Hospital
arm group label: Health Care professionals
description: Health Care professionals working within the CHU Brugmann Hospital
intervention type: Other
intervention name: Questionnaire
description: Data collection by means of various questionnaires
arm group label: Elderly patients
arm group label: Health Care professionals
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sophie Levy, MD
role: Principal Investigator
affiliation: CHU Brugmann
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Murielle Surquin
investigator title: Head of geriatry department
mesh term: COVID-19
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
sharing ipd: No