<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/NCT03286439</url>
  </required_header>
  <id_info>
    <org_study_id>NA-1-2017</org_study_id>
    <nct_id>NCT03286439</nct_id>
  </id_info>
  <brief_title>Recovery After Medical or Surgical Treatment</brief_title>
  <official_title>Recovery After Medical or Surgical Treatment - A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to investigate the in-hospital care as well as the cognitive status, quality&#xD;
      of life, physical function and risk of anxiety and depression, sleep disorders and drug use&#xD;
      in a Danish cohort of both medical and surgical patients with acute critical illness without&#xD;
      admittance to ICU (Intensive Care Unit) treatment, at three and twelve months after hospital&#xD;
      discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A stay at the ICU (intensive Care Unit) is related to life-threatening conditions and often&#xD;
      displays a major impact on both physical and mental resources of the patients. Studies show&#xD;
      that a great part of ICU patients have impairments of both physical and psychological kinds,&#xD;
      some long-lasting. This condition is termed the &quot;post intensive care syndrome&quot; (PICS) and&#xD;
      describes a wide range of symptoms as fatigue, depression, anxiety, memory loss along with&#xD;
      both cognitive and physical impairments. Rehabilitative efforts are, thus, needed, and it has&#xD;
      been suggested that ideally, rehabilitation should begin at the time of admission to the&#xD;
      hospital and continue for a long time, possibly years, after the patient has been discharged.&#xD;
      Regarding long term cognitive function of the ICU survivors in particular, recent studies&#xD;
      have demonstrated severe impairment at the level of light Alzheimer's disease. In all of&#xD;
      these studies, the reference group is the normal population, and it is a general problem that&#xD;
      the cognitive and physical function of ICU patients before critical illness is unknown. There&#xD;
      has recently been a norwegian study that included a reference group of surgical patients&#xD;
      undergoing major surgery. The surgical group was older and more severely ill than the ICU&#xD;
      group and was found to have a much worse cognitive function. Moreover, the cognitive function&#xD;
      of the critically ill patients was not very far from the normal reference population due to&#xD;
      selection.&#xD;
&#xD;
      To determine to which degree the impairments can be attributed to ICU-admission, the&#xD;
      investigators need to look at a hospitalised and representative, non-ICU population, which is&#xD;
      what will be done in the study. The investigators will therefore include patients that have&#xD;
      been admitted to surgical or medical department acute without admittance to the ICU and&#xD;
      contact these patients 3 and 12 months after admission. Where there will be performed&#xD;
      different tests in order to evaluate the the cognitive status, quality of life, physical&#xD;
      function and risk of anxiety and depression, sleep disorders and drug use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">July 6, 2018</completion_date>
  <primary_completion_date type="Actual">July 6, 2018</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>Cognitive function</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>Cognitive Function measured by The Repeatable Battery for The Assesment of Neuropsychological Status (RBANS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive function after one year</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>Cognitive function measured with The Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) evaluation at 12 months after discharge from hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rehabilitation after 3 months</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>This will be investigated by filling out a checklist of community support and contact to health care system at 3 month follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported health related quality of life</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported health related quality of life</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective assessment of physical function</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective assessment of physical function</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days after discharge</time_frame>
    <description>The mortality of the patients within 90 days after hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of opioids</measure>
    <time_frame>90 days after discharge</time_frame>
    <description>Percentage of patients with a daily consumption of opioids at hospital admission and 90 days after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of statins days after discharge</measure>
    <time_frame>90 days after discharge</time_frame>
    <description>Percentage of patients with a daily consumption of statins at hospital admission and at 90 days after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of anti-depressants</measure>
    <time_frame>90 days after discharge</time_frame>
    <description>Percentage of patients with a daily consumption of anti-depressants at hospital admission and at 90 days after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleepiness</measure>
    <time_frame>At inclusion</time_frame>
    <description>This will be investigated by filling out Epworth Sleepiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleepiness</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>This will be investigated by filling out Epworth Sleepiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleepiness</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>This will be investigated by filling out Epworth Sleepiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>At inclusion</time_frame>
    <description>This will be investigated by filling out Insomnia Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>This will be investigated by filling out Insomnia Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>This will be investigated by filling out Insomnia Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>At inclusion</time_frame>
    <description>This will be investigated by filling out Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>This will be investigated by filling out Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>This will be investigated by filling out Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Information processing speed</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>This will be investigated by filling out the Trail Making Test Part A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Information processing speed</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>This will be investigated by filling out the Trail Making Test Part A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive function</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>This will be investigated by filling out the Trail Making Test Part B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive function</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>This will be investigated by filling out the Trail Making Test Part B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rehabilitation after 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>This will be investigated by filling out a checklist of Community support and contact to health care system at 3 month follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of sleep medication</measure>
    <time_frame>At inclusion</time_frame>
    <description>Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of sleep medication</measure>
    <time_frame>90 days after discharge</time_frame>
    <description>Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of sleep medication</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge</description>
  </secondary_outcome>
  <enrollment type="Actual">101</enrollment>
  <condition>Cognitive Deficit</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>there will be offered a follow up visit</intervention_name>
    <description>The investigators will offer the patients a follow up visit 3 and 12 months after discharge from the hospital.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of critically ill patients that have been admitted to&#xD;
        surgical or Medical departement.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years of age&#xD;
&#xD;
          -  Admitted to surgical or medical department &gt; 3 days&#xD;
&#xD;
          -  Admitted with one of the following diagnoses:&#xD;
&#xD;
               -  Pneumonia&#xD;
&#xD;
               -  Heart failure&#xD;
&#xD;
               -  Pulmonary embolism&#xD;
&#xD;
               -  Acute myocardial infarction&#xD;
&#xD;
               -  Pyelonephritis&#xD;
&#xD;
               -  Patients undergoing non-elective open or laparoscopic abdominal surgery (not&#xD;
                  including elective procedures, diseases of the appendix, diseases of the&#xD;
                  gallbladder, liver, spleen, kidney, pancreas and emergency hernia surgery without&#xD;
                  bowel resection)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Permanently incompetent patients not able to consent&#xD;
&#xD;
          -  Not able to speak and understand Danish&#xD;
&#xD;
          -  Discharged from the hospital for terminal care&#xD;
&#xD;
          -  Patients transferred to another hospital during the stay&#xD;
&#xD;
          -  Patients living outside the Region of Zealand&#xD;
&#xD;
          -  Patients admitted under duress or actively psychotic&#xD;
&#xD;
          -  Patients that are blind or severely visually impaired.&#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>Stine Estrup, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stine Estrup</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zealand University Hospital</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 23, 2018</last_update_submitted>
  <last_update_submitted_qc>September 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zealand University Hospital</investigator_affiliation>
    <investigator_full_name>Stine Estrup</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognition Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT03286439
org study id: NA-1-2017
nct id: NCT03286439
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the in-hospital care as well as the cognitive status, quality
      of life, physical function and risk of anxiety and depression, sleep disorders and drug use
      in a Danish cohort of both medical and surgical patients with acute critical illness without
      admittance to ICU (Intensive Care Unit) treatment, at three and twelve months after hospital
      discharge.
A stay at the ICU (intensive Care Unit) is related to life-threatening conditions and often
      displays a major impact on both physical and mental resources of the patients. Studies show
      that a great part of ICU patients have impairments of both physical and psychological kinds,
      some long-lasting. This condition is termed the "post intensive care syndrome" (PICS) and
      describes a wide range of symptoms as fatigue, depression, anxiety, memory loss along with
      both cognitive and physical impairments. Rehabilitative efforts are, thus, needed, and it has
      been suggested that ideally, rehabilitation should begin at the time of admission to the
      hospital and continue for a long time, possibly years, after the patient has been discharged.
      Regarding long term cognitive function of the ICU survivors in particular, recent studies
      have demonstrated severe impairment at the level of light Alzheimer's disease. In all of
      these studies, the reference group is the normal population, and it is a general problem that
      the cognitive and physical function of ICU patients before critical illness is unknown. There
      has recently been a norwegian study that included a reference group of surgical patients
      undergoing major surgery. The surgical group was older and more severely ill than the ICU
      group and was found to have a much worse cognitive function. Moreover, the cognitive function
      of the critically ill patients was not very far from the normal reference population due to
      selection.

      To determine to which degree the impairments can be attributed to ICU-admission, the
      investigators need to look at a hospitalised and representative, non-ICU population, which is
      what will be done in the study. The investigators will therefore include patients that have
      been admitted to surgical or medical department acute without admittance to the ICU and
      contact these patients 3 and 12 months after admission. Where there will be performed
      different tests in order to evaluate the the cognitive status, quality of life, physical
      function and risk of anxiety and depression, sleep disorders and drug use.
observational model: Cohort
time perspective: Prospective
measure: Cognitive function
time frame: 3 months after discharge
description: Cognitive Function measured by The Repeatable Battery for The Assesment of Neuropsychological Status (RBANS)
measure: Cognitive function after one year
time frame: 12 months after discharge
description: Cognitive function measured with The Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) evaluation at 12 months after discharge from hospital
measure: Rehabilitation after 3 months
time frame: 3 months after discharge
description: This will be investigated by filling out a checklist of community support and contact to health care system at 3 month follow up
measure: Self-reported health related quality of life
time frame: 3 months after discharge
description: This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.
measure: Self-reported health related quality of life
time frame: 12 months after discharge
description: This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.
measure: Objective assessment of physical function
time frame: 3 months after discharge
description: This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool.
measure: Objective assessment of physical function
time frame: 12 months after discharge
description: This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool
measure: Mortality
time frame: 90 days after discharge
description: The mortality of the patients within 90 days after hospital discharge.
measure: Consumption of opioids
time frame: 90 days after discharge
description: Percentage of patients with a daily consumption of opioids at hospital admission and 90 days after discharge
measure: Consumption of statins days after discharge
time frame: 90 days after discharge
description: Percentage of patients with a daily consumption of statins at hospital admission and at 90 days after discharge
measure: Consumption of anti-depressants
time frame: 90 days after discharge
description: Percentage of patients with a daily consumption of anti-depressants at hospital admission and at 90 days after discharge
measure: Sleepiness
time frame: At inclusion
description: This will be investigated by filling out Epworth Sleepiness Scale
measure: Sleepiness
time frame: 3 months after discharge
description: This will be investigated by filling out Epworth Sleepiness Scale
measure: Sleepiness
time frame: 12 months after discharge
description: This will be investigated by filling out Epworth Sleepiness Scale
measure: Insomnia
time frame: At inclusion
description: This will be investigated by filling out Insomnia Severity Index
measure: Insomnia
time frame: 3 months after discharge
description: This will be investigated by filling out Insomnia Severity Index
measure: Insomnia
time frame: 12 months after discharge
description: This will be investigated by filling out Insomnia Severity Index
measure: Sleep Quality
time frame: At inclusion
description: This will be investigated by filling out Pittsburgh Sleep Quality Index
measure: Sleep Quality
time frame: 3 months after discharge
description: This will be investigated by filling out Pittsburgh Sleep Quality Index
measure: Sleep Quality
time frame: 12 months after discharge
description: This will be investigated by filling out Pittsburgh Sleep Quality Index
measure: Information processing speed
time frame: 3 months after discharge
description: This will be investigated by filling out the Trail Making Test Part A
measure: Information processing speed
time frame: 12 months after discharge
description: This will be investigated by filling out the Trail Making Test Part A
measure: Executive function
time frame: 3 months after discharge
description: This will be investigated by filling out the Trail Making Test Part B
measure: Executive function
time frame: 12 months after discharge
description: This will be investigated by filling out the Trail Making Test Part B
measure: Rehabilitation after 12 months
time frame: 12 months
description: This will be investigated by filling out a checklist of Community support and contact to health care system at 3 month follow up
measure: Consumption of sleep medication
time frame: At inclusion
description: Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge
measure: Consumption of sleep medication
time frame: 90 days after discharge
description: Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge
measure: Consumption of sleep medication
time frame: 12 months after discharge
description: Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge
intervention type: Other
intervention name: there will be offered a follow up visit
description: The investigators will offer the patients a follow up visit 3 and 12 months after discharge from the hospital.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stine Estrup, MD
role: Principal Investigator
affiliation: Stine Estrup
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: Stine Estrup
investigator title: Principal Investigator
mesh term: Cognition Disorders
mesh term: Cognitive Dysfunction
sharing ipd: No