<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/NCT03785444</url>
  </required_header>
  <id_info>
    <org_study_id>ASTON</org_study_id>
    <nct_id>NCT03785444</nct_id>
  </id_info>
  <brief_title>Comparison of Self-assessment vs. Assessment by Others of Critically Ill Patients</brief_title>
  <acronym>ASTON</acronym>
  <official_title>Agreement in Relatives' Assessment in Standardized Questionnaires of Patients Who Have Been Admitted to Intensive Care Compared to Patients Who Have Not Been Admitted to Intensive Care (ASTON Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technical University of Munich</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>
      We will test the results of standardized questionnaires for patients admitted to intensive&#xD;
      care assessed by relatives/caregivers compared to the patient itself. Furthermore we will&#xD;
      compare results with patients not admitted to intensive care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">August 15, 2020</completion_date>
  <primary_completion_date type="Actual">August 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Agreement in assessment of ICU patients</measure>
    <time_frame>2 weeks before hospital admission</time_frame>
    <description>Comparison of results of self-assessment versus assessment by others of standardized questionnaires of postoperative patients admitted to intensive care</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Agreement in assessment of ICU vs. non-ICU patients</measure>
    <time_frame>2 weeks before hospital admission</time_frame>
    <description>Comparison of results of assessment of questionnaires of ICU patients vs. non-ICU patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Agreement in assessment of non-ICU patients</measure>
    <time_frame>2 weeks before hospital admission</time_frame>
    <description>Comparison of results of self-assessment versus assessment by others of standardized questionnaires of postoperative patients not admitted to intensive care but to the normal ward</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multivariate testing using the closeness of the relationship</measure>
    <time_frame>2 weeks before hospital admission</time_frame>
    <description>It will be tested if the closeness of relationship patient - relative/caregiver changes the agreement, i.e. if the agreement is dependent or independent of the closeness of the relationship</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Definition of criteria which define an appropriate close relationship to receive a reliable test result</measure>
    <time_frame>2 weeks before hospital admission</time_frame>
    <description>Test which closeness of relationship is sufficient to provide adequate test results compared with the patient's answers</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Critical Illness</condition>
  <condition>Self-Assessment</condition>
  <condition>Assessment, Self</condition>
  <arm_group>
    <arm_group_label>Intensive Care Patients</arm_group_label>
    <description>Postoperative patients who have been admitted to intensive care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Intensive Care Patients</arm_group_label>
    <description>Postoperative patients who have not been admitted to intensive care but to the normal ward</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WHODAS 2.0</intervention_name>
    <description>WHO Disability Score</description>
    <arm_group_label>Intensive Care Patients</arm_group_label>
    <arm_group_label>Non-Intensive Care Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EQ5D</intervention_name>
    <description>Health related quality of life measured with European Quality of Life 5 Dimensions 5 Level</description>
    <arm_group_label>Intensive Care Patients</arm_group_label>
    <arm_group_label>Non-Intensive Care Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IADL</intervention_name>
    <description>The Lawton Instrumental Activities of Daily Living</description>
    <arm_group_label>Intensive Care Patients</arm_group_label>
    <arm_group_label>Non-Intensive Care Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Barthel-Score</intervention_name>
    <description>Barthel Score of the patient</description>
    <arm_group_label>Intensive Care Patients</arm_group_label>
    <arm_group_label>Non-Intensive Care Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SF-36</intervention_name>
    <description>Short Form Health 36</description>
    <arm_group_label>Intensive Care Patients</arm_group_label>
    <arm_group_label>Non-Intensive Care Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MoCA Blind</intervention_name>
    <description>Montreal Cognitive Assessment</description>
    <arm_group_label>Intensive Care Patients</arm_group_label>
    <arm_group_label>Non-Intensive Care Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Surgical patients with a high risk to be admitted to intensive care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with a postoperative risk to be admitted to intensive care&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient who is not able to fill out the questionnaires alone and independent&#xD;
&#xD;
          -  patient without relatives or a caregiver who could answer the assessment after surgery&#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>Stefan J Schaller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Technical University of Munich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steffen Weber-Carstens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum rechts der Isar, School of Medicine, Technical University of Munich</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Assessment by others</keyword>
  <keyword>Self-Assessment</keyword>
  <keyword>Critically ill</keyword>
  <keyword>Intensive care</keyword>
  <keyword>standardized questionnaire</keyword>
  <keyword>functional status</keyword>
  <keyword>WHODAS</keyword>
  <keyword>EQ5D</keyword>
  <keyword>IADL</keyword>
  <keyword>Barthel Score</keyword>
  <keyword>SF-36</keyword>
  <keyword>MoCA Blind</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Anonymized data will be made available to other researchers on reasonable request. A data share agreement will have to be signed by both parties.&#xD;
Examples of reasonable requests are:&#xD;
a metaanalysis in the field&#xD;
a research collaboration&#xD;
rerun the analysis&#xD;
Data will only be provided for the purpose requested and may not be used otherwise without authorization/agreement.</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/NCT03785444
org study id: ASTON
nct id: NCT03785444
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We will test the results of standardized questionnaires for patients admitted to intensive
      care assessed by relatives/caregivers compared to the patient itself. Furthermore we will
      compare results with patients not admitted to intensive care.
observational model: Case-Control
time perspective: Prospective
measure: Agreement in assessment of ICU patients
time frame: 2 weeks before hospital admission
description: Comparison of results of self-assessment versus assessment by others of standardized questionnaires of postoperative patients admitted to intensive care
measure: Agreement in assessment of ICU vs. non-ICU patients
time frame: 2 weeks before hospital admission
description: Comparison of results of assessment of questionnaires of ICU patients vs. non-ICU patients
measure: Agreement in assessment of non-ICU patients
time frame: 2 weeks before hospital admission
description: Comparison of results of self-assessment versus assessment by others of standardized questionnaires of postoperative patients not admitted to intensive care but to the normal ward
measure: Multivariate testing using the closeness of the relationship
time frame: 2 weeks before hospital admission
description: It will be tested if the closeness of relationship patient - relative/caregiver changes the agreement, i.e. if the agreement is dependent or independent of the closeness of the relationship
measure: Definition of criteria which define an appropriate close relationship to receive a reliable test result
time frame: 2 weeks before hospital admission
description: Test which closeness of relationship is sufficient to provide adequate test results compared with the patient's answers
arm group label: Intensive Care Patients
description: Postoperative patients who have been admitted to intensive care
arm group label: Non-Intensive Care Patients
description: Postoperative patients who have not been admitted to intensive care but to the normal ward
intervention type: Other
intervention name: WHODAS 2.0
description: WHO Disability Score
arm group label: Intensive Care Patients
arm group label: Non-Intensive Care Patients
intervention type: Other
intervention name: EQ5D
description: Health related quality of life measured with European Quality of Life 5 Dimensions 5 Level
arm group label: Intensive Care Patients
arm group label: Non-Intensive Care Patients
intervention type: Other
intervention name: IADL
description: The Lawton Instrumental Activities of Daily Living
arm group label: Intensive Care Patients
arm group label: Non-Intensive Care Patients
intervention type: Other
intervention name: Barthel-Score
description: Barthel Score of the patient
arm group label: Intensive Care Patients
arm group label: Non-Intensive Care Patients
intervention type: Other
intervention name: SF-36
description: Short Form Health 36
arm group label: Intensive Care Patients
arm group label: Non-Intensive Care Patients
intervention type: Other
intervention name: MoCA Blind
description: Montreal Cognitive Assessment
arm group label: Intensive Care Patients
arm group label: Non-Intensive Care Patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefan J Schaller, MD
role: Principal Investigator
affiliation: Technical University of Munich
last name: Steffen Weber-Carstens, MD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: Undecided
ipd description: Anonymized data will be made available to other researchers on reasonable request. A data share agreement will have to be signed by both parties.
Examples of reasonable requests are:
a metaanalysis in the field
a research collaboration
rerun the analysis
Data will only be provided for the purpose requested and may not be used otherwise without authorization/agreement.