<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/NCT04460170</url>
  </required_header>
  <id_info>
    <org_study_id>COFICS201800422</org_study_id>
    <nct_id>NCT04460170</nct_id>
  </id_info>
  <brief_title>COVID-19 Follow up Intensive Care Studies</brief_title>
  <acronym>COFICS</acronym>
  <official_title>COVID-19 Follow up Intensive Care Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hanze University of Applied Sciences Groningen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medical Center Groningen</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>
      Since the SARS-CoV-2 infection is relatively new, the long term attributable burden related&#xD;
      to COVID19 has not been investigated yet. To date, in patients with COVID-19 and their family&#xD;
      members, there is little information on the functional status, cognitive ability, pattern of&#xD;
      return to work, and health related quality of life after the ICU admission.&#xD;
&#xD;
      This study aims to describe the psychological wellbeing, physical - and social functioning of&#xD;
      COVID-19 ICU survivors and their family members up to 12 months following ICU discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design The COVID-19 Follow up Intensive Care Study (COFICS) is a single center,&#xD;
      prospective cohort study performed at a University Medical Center in The Netherlands.&#xD;
&#xD;
      Study population The study population consists of all admitted critically ill COVID-19&#xD;
      patients with a &gt; 48 hours ICU admission at the ICU of a University Medical Center and a&#xD;
      family member of the patient. Family members in this study can be partners, other family&#xD;
      members, or friends who are identified by the patient as important.&#xD;
&#xD;
      Sample size All consecutive patients admitted to the ICU of the University Hospital for&#xD;
      respiratory distress due to COVID-19 between March 19th 2020 and September 30th 2020 will be&#xD;
      enrolled. With consent of the patient, family member(s) of participating patients will be&#xD;
      enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2022</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>General Health</measure>
    <time_frame>3 months post ICU discharge</time_frame>
    <description>MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain.&#xD;
The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General Health</measure>
    <time_frame>6 months post ICU discharge</time_frame>
    <description>MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain.&#xD;
The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General Health</measure>
    <time_frame>12 months post ICU discharge</time_frame>
    <description>MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain.&#xD;
The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>3 months post ICU discharge</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>6 months post ICU discharge</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>12 months post ICU discharge</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long function</measure>
    <time_frame>6 months post ICU discharge (only in patients)</time_frame>
    <description>Spirometry test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long function</measure>
    <time_frame>12 months post ICU discharge (only in patients)</time_frame>
    <description>Spirometry test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frailty</measure>
    <time_frame>3 months post ICU discharge (only in patients)</time_frame>
    <description>Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frailty</measure>
    <time_frame>6 months post ICU discharge (only in patients)</time_frame>
    <description>Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frailty</measure>
    <time_frame>12 months post ICU discharge (only in patients)</time_frame>
    <description>Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Family functioning</measure>
    <time_frame>6 months post ICU discharge</time_frame>
    <description>McMaster Family Assessment Device (FAD-GF6+). The FAD-GF6+ contains 6 items (min. score 6, max. score 24) where a higher scores indicate a lower caregiver burden.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Family functioning</measure>
    <time_frame>12 months post ICU discharge</time_frame>
    <description>McMaster Family Assessment Device (FAD-GF6+). The FAD-GF6+ contains 6 items (min. score 6, max. score 24) where a higher scores indicate a lower caregiver burden.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of an ICU admission on return to work</measure>
    <time_frame>3 months post ICU discharge (only in family members)</time_frame>
    <description>Return to work knowing; possible job loss, change of work activities and worsening employment status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of an ICU admission on return to work</measure>
    <time_frame>6 months post ICU discharge</time_frame>
    <description>Return to work knowing; possible job loss, change of work activities and worsening employment status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of an ICU admission on return to work</measure>
    <time_frame>12 months post ICU discharge</time_frame>
    <description>Return to work knowing; possible job loss, change of work activities and worsening employment status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>age</measure>
    <time_frame>24 hours (patient) / 3 months post ICU discharge (family member)</time_frame>
    <description>age (years)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender</measure>
    <time_frame>24 hours (patient) / 3 months post ICU discharge (family member)</time_frame>
    <description>Gender (male/female)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social status</measure>
    <time_frame>3 months post ICU discharge</time_frame>
    <description>Social status (married/living together/ single)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APACHE IV</measure>
    <time_frame>24 hours (only in patients)</time_frame>
    <description>Acute Physiology And Chronic Health Evaluation (APACHE IV). It is applied within 24 hours of admission of a patient to an intensive care unit (ICU): based on several measurements; higher scores correspond to more severe disease and a higher risk of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comorbidity</measure>
    <time_frame>3 months post ICU discharge (only in patients)</time_frame>
    <description>Comorbidity ( free text)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>3 months post ICU discharge (only in patients)</time_frame>
    <description>Body mass index (kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>hospital discharge, an average of 4 weeks (only in patients)</time_frame>
    <description>ICU stay (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation</measure>
    <time_frame>hospital discharge, an average of 4 weeks (only in patients)</time_frame>
    <description>Mechanical ventilation (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delerium</measure>
    <time_frame>hospital discharge, an average of 4 weeks (only in patients)</time_frame>
    <description>Delerium (no / yes --&gt; CAM-ICU / DOS score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>hospital discharge, an average of 4 weeks (only in patients)</time_frame>
    <description>Hospital stay (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge locationn</measure>
    <time_frame>hospital discharge, an average of 4 weeks (only in patients)</time_frame>
    <description>Discharge location (home, other hospital, nursing home, revelidation center)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>3 months post ICU discharge (only in patients)</time_frame>
    <description>Mortality (no / yes --&gt; date)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>6 months post ICU discharge (only in patients)</time_frame>
    <description>Mortality (no / yes --&gt; date)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>12 months post ICU discharge (only in patients)</time_frame>
    <description>Mortality (no / yes --&gt; date)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship with the patient</measure>
    <time_frame>3 months post ICU discharge (only in family members)</time_frame>
    <description>Relationship with the patient (Partner, sibling, child, other)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Educational level</measure>
    <time_frame>3 months post ICU discharge</time_frame>
    <description>Educational level (low, middle, high)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>3 months post ICU discharge (only in patients)</time_frame>
    <description>Readmission (no / yes --&gt; free text)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care consumption</measure>
    <time_frame>3 months post ICU discharge</time_frame>
    <description>Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care consumption</measure>
    <time_frame>6 months post ICU discharge</time_frame>
    <description>Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care consumption</measure>
    <time_frame>12 months post ICU discharge</time_frame>
    <description>Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>3 months post ICU discharge</time_frame>
    <description>Weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>6 months post ICU discharge</time_frame>
    <description>Weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>12 months post ICU discharge</time_frame>
    <description>Weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertensive</measure>
    <time_frame>3 months post ICU discharge</time_frame>
    <description>Hypertensive (RR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertensive</measure>
    <time_frame>6 months post ICU discharge</time_frame>
    <description>Hypertensive (RR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertensive</measure>
    <time_frame>12 months post ICU discharge</time_frame>
    <description>Hypertensive (RR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis</measure>
    <time_frame>3 months post ICU discharge</time_frame>
    <description>Thrombosis (no / yes --&gt; anticoagulant, DVT or PE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis</measure>
    <time_frame>6 months post ICU discharge</time_frame>
    <description>Thrombosis (no / yes --&gt; anticoagulant, DVT or PE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis</measure>
    <time_frame>12 months post ICU discharge</time_frame>
    <description>Thrombosis (no / yes --&gt; anticoagulant, DVT or PE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes</measure>
    <time_frame>3 months post ICU discharge</time_frame>
    <description>Diabetes (no /yes --&gt; current insulin level, metformin/ insulin use)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes</measure>
    <time_frame>6 months post ICU discharge</time_frame>
    <description>Diabetes (no /yes --&gt; current insulin level, metformin/ insulin use)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes</measure>
    <time_frame>12 months post ICU discharge</time_frame>
    <description>Diabetes (no /yes --&gt; current insulin level, metformin/ insulin use)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Quality of Life</condition>
  <condition>COVID-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of all admitted critically ill COVID-19 patients with a &gt; 48&#xD;
        hours ICU admission at the ICU of a University Medical Center and a family member of the&#xD;
        patient. Family members in this study can be partners, other family members, or friends who&#xD;
        are identified by the patient as important.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years old&#xD;
&#xD;
          -  Ability to speak and write Dutch&#xD;
&#xD;
          -  Ability to conduct a telephone call&#xD;
&#xD;
          -  Diagnosed with COVID-19 infection (only in patients)&#xD;
&#xD;
          -  48 hours ICU admission (only in patients)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refuse to participate&#xD;
&#xD;
          -  Serious language barrier&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Severe psychiatric disorder&#xD;
&#xD;
          -  Chronic ventilator dependency (only in patients)&#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_contact>
    <last_name>I van der Meulen, PhD</last_name>
    <phone>+31503615617</phone>
    <email>i.c.van.der.meulen@pl.hanze.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9700 RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 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>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Willem Dieperink</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Critical Care</keyword>
  <keyword>Family Members</keyword>
  <keyword>Patients</keyword>
  <keyword>Follow-Up Studies</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04460170
org study id: COFICS201800422
nct id: NCT04460170
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since the SARS-CoV-2 infection is relatively new, the long term attributable burden related
      to COVID19 has not been investigated yet. To date, in patients with COVID-19 and their family
      members, there is little information on the functional status, cognitive ability, pattern of
      return to work, and health related quality of life after the ICU admission.

      This study aims to describe the psychological wellbeing, physical - and social functioning of
      COVID-19 ICU survivors and their family members up to 12 months following ICU discharge.
Study design The COVID-19 Follow up Intensive Care Study (COFICS) is a single center,
      prospective cohort study performed at a University Medical Center in The Netherlands.

      Study population The study population consists of all admitted critically ill COVID-19
      patients with a > 48 hours ICU admission at the ICU of a University Medical Center and a
      family member of the patient. Family members in this study can be partners, other family
      members, or friends who are identified by the patient as important.

      Sample size All consecutive patients admitted to the ICU of the University Hospital for
      respiratory distress due to COVID-19 between March 19th 2020 and September 30th 2020 will be
      enrolled. With consent of the patient, family member(s) of participating patients will be
      enrolled.
observational model: Cohort
time perspective: Prospective
measure: General Health
time frame: 3 months post ICU discharge
description: MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain.
The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.
measure: General Health
time frame: 6 months post ICU discharge
description: MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain.
The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.
measure: General Health
time frame: 12 months post ICU discharge
description: MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain.
The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.
measure: Anxiety and Depression
time frame: 3 months post ICU discharge
description: Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.
measure: Anxiety and Depression
time frame: 6 months post ICU discharge
description: Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.
measure: Anxiety and Depression
time frame: 12 months post ICU discharge
description: Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.
measure: Long function
time frame: 6 months post ICU discharge (only in patients)
description: Spirometry test
measure: Long function
time frame: 12 months post ICU discharge (only in patients)
description: Spirometry test
measure: Frailty
time frame: 3 months post ICU discharge (only in patients)
description: Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.
measure: Frailty
time frame: 6 months post ICU discharge (only in patients)
description: Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.
measure: Frailty
time frame: 12 months post ICU discharge (only in patients)
description: Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.
measure: Family functioning
time frame: 6 months post ICU discharge
description: McMaster Family Assessment Device (FAD-GF6+). The FAD-GF6+ contains 6 items (min. score 6, max. score 24) where a higher scores indicate a lower caregiver burden.
measure: Family functioning
time frame: 12 months post ICU discharge
description: McMaster Family Assessment Device (FAD-GF6+). The FAD-GF6+ contains 6 items (min. score 6, max. score 24) where a higher scores indicate a lower caregiver burden.
measure: Effect of an ICU admission on return to work
time frame: 3 months post ICU discharge (only in family members)
description: Return to work knowing; possible job loss, change of work activities and worsening employment status
measure: Effect of an ICU admission on return to work
time frame: 6 months post ICU discharge
description: Return to work knowing; possible job loss, change of work activities and worsening employment status
measure: Effect of an ICU admission on return to work
time frame: 12 months post ICU discharge
description: Return to work knowing; possible job loss, change of work activities and worsening employment status
measure: age
time frame: 24 hours (patient) / 3 months post ICU discharge (family member)
description: age (years)
measure: Gender
time frame: 24 hours (patient) / 3 months post ICU discharge (family member)
description: Gender (male/female)
measure: Social status
time frame: 3 months post ICU discharge
description: Social status (married/living together/ single)
measure: APACHE IV
time frame: 24 hours (only in patients)
description: Acute Physiology And Chronic Health Evaluation (APACHE IV). It is applied within 24 hours of admission of a patient to an intensive care unit (ICU): based on several measurements; higher scores correspond to more severe disease and a higher risk of death
measure: Comorbidity
time frame: 3 months post ICU discharge (only in patients)
description: Comorbidity ( free text)
measure: Body mass index
time frame: 3 months post ICU discharge (only in patients)
description: Body mass index (kg/m2)
measure: ICU stay
time frame: hospital discharge, an average of 4 weeks (only in patients)
description: ICU stay (days)
measure: Mechanical ventilation
time frame: hospital discharge, an average of 4 weeks (only in patients)
description: Mechanical ventilation (days)
measure: Delerium
time frame: hospital discharge, an average of 4 weeks (only in patients)
description: Delerium (no / yes --> CAM-ICU / DOS score)
measure: Hospital stay
time frame: hospital discharge, an average of 4 weeks (only in patients)
description: Hospital stay (days)
measure: Discharge locationn
time frame: hospital discharge, an average of 4 weeks (only in patients)
description: Discharge location (home, other hospital, nursing home, revelidation center)
measure: Mortality
time frame: 3 months post ICU discharge (only in patients)
description: Mortality (no / yes --> date)
measure: Mortality
time frame: 6 months post ICU discharge (only in patients)
description: Mortality (no / yes --> date)
measure: Mortality
time frame: 12 months post ICU discharge (only in patients)
description: Mortality (no / yes --> date)
measure: Relationship with the patient
time frame: 3 months post ICU discharge (only in family members)
description: Relationship with the patient (Partner, sibling, child, other)
measure: Educational level
time frame: 3 months post ICU discharge
description: Educational level (low, middle, high)
measure: Readmission
time frame: 3 months post ICU discharge (only in patients)
description: Readmission (no / yes --> free text)
measure: Health care consumption
time frame: 3 months post ICU discharge
description: Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))
measure: Health care consumption
time frame: 6 months post ICU discharge
description: Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))
measure: Health care consumption
time frame: 12 months post ICU discharge
description: Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))
measure: Weight
time frame: 3 months post ICU discharge
description: Weight (kg)
measure: Weight
time frame: 6 months post ICU discharge
description: Weight (kg)
measure: Weight
time frame: 12 months post ICU discharge
description: Weight (kg)
measure: Hypertensive
time frame: 3 months post ICU discharge
description: Hypertensive (RR)
measure: Hypertensive
time frame: 6 months post ICU discharge
description: Hypertensive (RR)
measure: Hypertensive
time frame: 12 months post ICU discharge
description: Hypertensive (RR)
measure: Thrombosis
time frame: 3 months post ICU discharge
description: Thrombosis (no / yes --> anticoagulant, DVT or PE)
measure: Thrombosis
time frame: 6 months post ICU discharge
description: Thrombosis (no / yes --> anticoagulant, DVT or PE)
measure: Thrombosis
time frame: 12 months post ICU discharge
description: Thrombosis (no / yes --> anticoagulant, DVT or PE)
measure: Diabetes
time frame: 3 months post ICU discharge
description: Diabetes (no /yes --> current insulin level, metformin/ insulin use)
measure: Diabetes
time frame: 6 months post ICU discharge
description: Diabetes (no /yes --> current insulin level, metformin/ insulin use)
measure: Diabetes
time frame: 12 months post ICU discharge
description: Diabetes (no /yes --> current insulin level, metformin/ insulin use)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: I van der Meulen, PhD
phone: +31503615617
email: i.c.van.der.meulen@pl.hanze.nl
facility: 
status: Recruiting
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Willem Dieperink
investigator title: PhD
mesh term: COVID-19