<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/NCT04422444</url>
  </required_header>
  <id_info>
    <org_study_id>2020/577</org_study_id>
    <nct_id>NCT04422444</nct_id>
  </id_info>
  <brief_title>Post Intensive Care Syndrome in COVID19 Patients</brief_title>
  <acronym>PICS-COVID19</acronym>
  <official_title>Characterization and Management of Post Intensive Care Syndrome in COVID19 Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is based in the implementation of a combined monitoring system (technological&#xD;
      solutions and medical visits) in survivors of the critical illness due to the infectious&#xD;
      disease by COVID-19. The main objective of the project is to characterize the Post-Intensive&#xD;
      Care Syndrome (PICS) and detect early needs for specific treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>12 Months</target_duration>
  <primary_outcome>
    <measure>Change from baseline Short Form 12 Health Survey (SF12) at 12 month</measure>
    <time_frame>Every month during a 12 months follow-up period</time_frame>
    <description>Health related quality of live scale. Values are directly transformed in T scores (mean=50; SD=10), with higher scores meaning better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Lawton &amp; Brody Instrumental activities of daily living scale at 12 months</measure>
    <time_frame>Every month during a 12 months follow-up period</time_frame>
    <description>Measure of independent living skills. Values are from 0 to 8, with higher scores meaning better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Perceived Deficits Questionnaire (PDQ) at 12 months</measure>
    <time_frame>Every month during a 12 months follow-up period</time_frame>
    <description>Self-report measure of cognitive dysfunction. Values are from 0 to 22, with lower scores meaning better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Hospital Anxiety and Depression Scale (HADS) at 12 months</measure>
    <time_frame>Every month during a 12 months follow-up period</time_frame>
    <description>A self-assessment instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient. Values are from 0 to 42, with lower scores meaning better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Davidson Trauma Scale (DTS) at 12 months</measure>
    <time_frame>Every month during a 12 months follow-up period. Values are from 0 to 136, with lower scores meaning better outcome.</time_frame>
    <description>Self-report measure of Post Traumatic Stress Disorder (PTSD) symptoms.</description>
  </secondary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>COVID19</condition>
  <condition>Post Intensive Care Unit Syndrome</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Participants will answer questionnaires in three areas: physical/functional, emotional status and cognitive status</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        ICU patients with COVID19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to ICU for COVID 19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental health diagnosis previous to the COVID19 infection&#xD;
&#xD;
          -  Acquired brain damage or neurological disease previous to the COVID19 infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>SOL FERNANDEZ, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut d'Investigació i Innovació Parc Taulí (I3PT)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corporació Parc Taulí</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Sol Fernandez-Gonzalo</investigator_full_name>
    <investigator_title>Postdoctoral neuropsychology researcher</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>Syndrome</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/NCT04422444
org study id: 2020/577
nct id: NCT04422444
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This project is based in the implementation of a combined monitoring system (technological
      solutions and medical visits) in survivors of the critical illness due to the infectious
      disease by COVID-19. The main objective of the project is to characterize the Post-Intensive
      Care Syndrome (PICS) and detect early needs for specific treatment.
observational model: Cohort
time perspective: Prospective
measure: Change from baseline Short Form 12 Health Survey (SF12) at 12 month
time frame: Every month during a 12 months follow-up period
description: Health related quality of live scale. Values are directly transformed in T scores (mean=50; SD=10), with higher scores meaning better outcome.
measure: Change from baseline Lawton & Brody Instrumental activities of daily living scale at 12 months
time frame: Every month during a 12 months follow-up period
description: Measure of independent living skills. Values are from 0 to 8, with higher scores meaning better outcome.
measure: Change from baseline Perceived Deficits Questionnaire (PDQ) at 12 months
time frame: Every month during a 12 months follow-up period
description: Self-report measure of cognitive dysfunction. Values are from 0 to 22, with lower scores meaning better outcome.
measure: Change from baseline Hospital Anxiety and Depression Scale (HADS) at 12 months
time frame: Every month during a 12 months follow-up period
description: A self-assessment instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient. Values are from 0 to 42, with lower scores meaning better outcome.
measure: Change from baseline Davidson Trauma Scale (DTS) at 12 months
time frame: Every month during a 12 months follow-up period. Values are from 0 to 136, with lower scores meaning better outcome.
description: Self-report measure of Post Traumatic Stress Disorder (PTSD) symptoms.
intervention type: Diagnostic Test
intervention name: Questionnaires
description: Participants will answer questionnaires in three areas: physical/functional, emotional status and cognitive status
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
last name: SOL FERNANDEZ, PhD
role: Principal Investigator
affiliation: Institut d'Investigació i Innovació Parc Taulí (I3PT)
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Sol Fernandez-Gonzalo
investigator title: Postdoctoral neuropsychology researcher
mesh term: COVID-19
mesh term: Syndrome