<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/NCT04416464</url>
  </required_header>
  <id_info>
    <org_study_id>QoL_ICU_COVID</org_study_id>
    <nct_id>NCT04416464</nct_id>
  </id_info>
  <brief_title>Quality of Life and Patient-centered Outcomes After ICU Admission for COVID-19</brief_title>
  <official_title>Quality of Life and Long-term Outcomes in Patients With Pneumonia Associated With SARS-Cov2 Infection, Survivors of Intensive Care Units: a Prospective Multicenter Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro Hospitalar De São João, E.P.E.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro Hospitalar do Porto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidade do Algarve</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro Hospitalar Lisboa Ocidental</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade do Porto</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>
      Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the&#xD;
      Intensive Care Unit (ICU), are susceptible to development of various functional sequelae,&#xD;
      increased risk of chronic diseases, increased mortality rates and existence of relevant&#xD;
      impacts on their quality of life in the months and years that follow the ICU admission. The&#xD;
      present study aims to assess the determinants of health-related quality of life and&#xD;
      patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after&#xD;
      discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter&#xD;
      prospective cohort study of adult patients admitted at the ICU due to proven or suspected&#xD;
      SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is&#xD;
      one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are&#xD;
      all-cause mortality, rehospitalizations, return to work or study, the degree of dependence&#xD;
      and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of&#xD;
      physical activity and cognitive, renal and respiratory functions after ICU discharge.&#xD;
      Investigators will collect data by means of structured telephone interviews, at a 12 months&#xD;
      follow up period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 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>Health-related quality of life.</measure>
    <time_frame>One-year (12 months) after ICU discharge.</time_frame>
    <description>The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay at the ICU.</measure>
    <time_frame>The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).</time_frame>
    <description>Length of stay at the ICU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of all-cause mortality</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>Incidence of all-cause mortality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rehospitalization.</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>Rehospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of long-term ventilatory support need.</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of renal replacement therapy need.</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>Percentage of patients requiring any kind of renal replacement therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of anxiety and depression.</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of functional independence.</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>The outcome will be assessed using the Lawton &amp; Brody Instrumental Activities of Daily Living Scale, a score of instrumental activities of daily living (the score ranges from 0 to 8, with higher scores indicating less dependence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of cognitive function.</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>The outcome will be assessed using the The Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, in 8 domains, with higher scores indicating worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of major cardiac events.</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>Percentage of major cardiac events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Chronic obstructive pulmonary disease (COPD)</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>Score of Chronic obstructive pulmonary disease (COPD) assessed using the Portuguese version of the Clinical COPD Questionnaire (CCQ). The Clinical COPD, consisting of 10 items (each scored between 0 and 6), divided into three domains (symptoms, functional, mental). The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse scenario.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of posttraumatic stress disorder</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility score of health-related quality of life at 3, 6, and 9 months.</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of self-rated health.</measure>
    <time_frame>The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.</time_frame>
    <description>The outcome will be assessed using the visual analogue scale of the Portuguese version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">280</enrollment>
  <condition>Quality of Life</condition>
  <condition>Long-term Outcomes</condition>
  <condition>Coronavirus Infection</condition>
  <condition>Morality</condition>
  <condition>Rehospitalization</condition>
  <arm_group>
    <arm_group_label>Pneumonia due to SARS-CoV-2 infection</arm_group_label>
    <description>Adult hospitalized patients with pneumonia due to proven or suspected SARS-Cov-2 infection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COVID-19 Pneumonia</intervention_name>
    <description>Pneumonia due to proven or suspected SARS-Cov-2 infection</description>
    <arm_group_label>Pneumonia due to SARS-CoV-2 infection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult survivors of ICU admission and pneumonia due to proven or suspected SARS-CoV-2&#xD;
        infection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 years and older&#xD;
&#xD;
          -  Admission to the intensive care unit (ICU)&#xD;
&#xD;
          -  Pneumonia due to proven or suspected SARS-CoV-2 infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to provide consent for the study by the patient or legal guardian&#xD;
&#xD;
          -  ICU length of stay less than 24 hours&#xD;
&#xD;
          -  Absence of telephone contact&#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>Luís Filipe Azevedo, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade do Porto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Hospitalar de Vila Nova de Gaia / Espinho - Unidade I</name>
      <address>
        <city>Vila Nova De Gaia</city>
        <state>Porto</state>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário de São João</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário do Porto - Hospital de Santo António</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>June 2021</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>September 9, 2021</last_update_submitted>
  <last_update_submitted_qc>September 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2021</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>Infections</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.</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/NCT04416464
org study id: QoL_ICU_COVID
nct id: NCT04416464
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the
      Intensive Care Unit (ICU), are susceptible to development of various functional sequelae,
      increased risk of chronic diseases, increased mortality rates and existence of relevant
      impacts on their quality of life in the months and years that follow the ICU admission. The
      present study aims to assess the determinants of health-related quality of life and
      patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after
      discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter
      prospective cohort study of adult patients admitted at the ICU due to proven or suspected
      SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is
      one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are
      all-cause mortality, rehospitalizations, return to work or study, the degree of dependence
      and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of
      physical activity and cognitive, renal and respiratory functions after ICU discharge.
      Investigators will collect data by means of structured telephone interviews, at a 12 months
      follow up period.
observational model: Cohort
time perspective: Prospective
measure: Health-related quality of life.
time frame: One-year (12 months) after ICU discharge.
description: The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
measure: Length of stay at the ICU.
time frame: The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).
description: Length of stay at the ICU.
measure: Incidence of all-cause mortality
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: Incidence of all-cause mortality.
measure: Rehospitalization.
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: Rehospitalization.
measure: Percentage of long-term ventilatory support need.
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.
measure: Percentage of renal replacement therapy need.
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: Percentage of patients requiring any kind of renal replacement therapy.
measure: Symptoms of anxiety and depression.
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).
measure: Score of functional independence.
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale, a score of instrumental activities of daily living (the score ranges from 0 to 8, with higher scores indicating less dependence).
measure: Score of cognitive function.
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: The outcome will be assessed using the The Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, in 8 domains, with higher scores indicating worse symptoms.
measure: Percentage of major cardiac events.
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: Percentage of major cardiac events.
measure: Score of Chronic obstructive pulmonary disease (COPD)
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: Score of Chronic obstructive pulmonary disease (COPD) assessed using the Portuguese version of the Clinical COPD Questionnaire (CCQ). The Clinical COPD, consisting of 10 items (each scored between 0 and 6), divided into three domains (symptoms, functional, mental). The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse scenario.
measure: Symptoms of posttraumatic stress disorder
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).
measure: Utility score of health-related quality of life at 3, 6, and 9 months.
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
measure: Score of self-rated health.
time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
description: The outcome will be assessed using the visual analogue scale of the Portuguese version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).
arm group label: Pneumonia due to SARS-CoV-2 infection
description: Adult hospitalized patients with pneumonia due to proven or suspected SARS-Cov-2 infection.
intervention type: Other
intervention name: COVID-19 Pneumonia
description: Pneumonia due to proven or suspected SARS-Cov-2 infection
arm group label: Pneumonia due to SARS-CoV-2 infection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luís Filipe Azevedo, Prof.
role: Principal Investigator
affiliation: Universidade do Porto
facility: 
facility: 
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Infections
mesh term: Coronavirus Infections
sharing ipd: Undecided
ipd description: The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.