<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/NCT04406181</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-19 Cardiac psy wellbeing</org_study_id>
    <nct_id>NCT04406181</nct_id>
  </id_info>
  <brief_title>Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic</brief_title>
  <official_title>Effect on the COVID-19 Pandemic-induced Reduction in Elective Surgery on Medical Events and Psychological Well-being of Patients Waiting for Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</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>
      The effect and impact of postponing cardiac surgery / creating a waiting list as a result of&#xD;
      COVID-19 on patients, both psychologically and symptomatically on three groups of patients:&#xD;
&#xD;
        1. The degree of anxiety and/or depression induced by their altered medical care&#xD;
           trajectory.&#xD;
&#xD;
        2. The incidence of medical problems induced by deferred elective surgery or delayed&#xD;
           postoperative ambulatory visit&#xD;
&#xD;
        3. The occurrence of reduced access to medical and psychological help&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective study by means of a questionnaire, specifically designed for each of the three&#xD;
      groups.&#xD;
&#xD;
        1. Adult patients whose operation date has been deferred&#xD;
&#xD;
        2. Patients who did not have had an operation date&#xD;
&#xD;
        3. Patients who have been operating on during the month before&#xD;
&#xD;
      Each group will receive a twofold questionnaire:&#xD;
&#xD;
      Part I: Hospital Anxiety and Depression Scale (HADS), a robust questionnaire used for&#xD;
      hospitalized and non-hospitalized patients gauging the degree of anxiety and/or depression,&#xD;
      irrespective of their specific medical condition. All three groups receive the same list of&#xD;
      questions.&#xD;
&#xD;
      -Part II: a questionnaire made up specifically for issues concerning the&#xD;
      medical/psychological/access aspects during the COVID-19 outbreak. Each of the three groups&#xD;
      will receive a questionnaire, adapted to the group they are assigned to.&#xD;
&#xD;
      The questionnaires will be delivered by the use of Qualtrics or on paper. Timing and mode of&#xD;
      presentation (Qualtrics or fill-in paper on admission) of the questionnaire will depend on&#xD;
      the length of the quarantine measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 18, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>10 minutes</time_frame>
    <description>The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit</measure>
    <time_frame>10 minutes</time_frame>
    <description>The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduced access to medical and psychological help</measure>
    <time_frame>10 minutes</time_frame>
    <description>The occurrence of reduced access to medical and psychological help by means of an adjusted survey.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Anxiety and Fear</condition>
  <condition>Anxiety Depression</condition>
  <condition>Anxiety Postoperative</condition>
  <condition>Psychological Stress</condition>
  <arm_group>
    <arm_group_label>operation deferred</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Adult patients whose operation date has been deferred due to the pandemic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no operation date</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started</description>
  </arm_group>
  <arm_group>
    <arm_group_label>postoperative consultation deferred</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients who have been operating on during the month before the pandemic</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HADS</intervention_name>
    <description>Hospital Anxiety and Depression Scale</description>
    <arm_group_label>no operation date</arm_group_label>
    <arm_group_label>operation deferred</arm_group_label>
    <arm_group_label>postoperative consultation deferred</arm_group_label>
    <other_name>questionnaire</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>a survey</intervention_name>
    <description>made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak</description>
    <arm_group_label>no operation date</arm_group_label>
    <arm_group_label>operation deferred</arm_group_label>
    <arm_group_label>postoperative consultation deferred</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All adult patients whose operation date has been deferred due to the pandemic COVID-19.&#xD;
&#xD;
        All patients who did not have had an operation date before the pandemic COVID-19.&#xD;
&#xD;
        All patients who have been operating on during the month before the pandemic COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Nijs, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark La Meir, Phd, MD</last_name>
    <role>Study Director</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ashley Welch, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Veerle Van Mossevelde, Data Nurse</last_name>
    <phone>+3224763134</phone>
    <email>veerle.vanmossevelde@uzbrussel.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>universitair Ziekenhuis Brussel</name>
      <address>
        <city>Jette</city>
        <state>Vlaams Brabant</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Veerle Van Mossevelde</last_name>
      <phone>+3224763134</phone>
      <email>veerle.vanmossevelde@uzbrussel.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>April 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Veerle Van Mossevelde</investigator_full_name>
    <investigator_title>Data Nurse</investigator_title>
  </responsible_party>
  <keyword>cardiac surgery</keyword>
  <keyword>postoperative consultation</keyword>
  <keyword>postponed elective surgery</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Stress, Psychological</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/NCT04406181
org study id: COVID-19 Cardiac psy wellbeing
nct id: NCT04406181
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effect and impact of postponing cardiac surgery / creating a waiting list as a result of
      COVID-19 on patients, both psychologically and symptomatically on three groups of patients:

        1. The degree of anxiety and/or depression induced by their altered medical care
           trajectory.

        2. The incidence of medical problems induced by deferred elective surgery or delayed
           postoperative ambulatory visit

        3. The occurrence of reduced access to medical and psychological help
A prospective study by means of a questionnaire, specifically designed for each of the three
      groups.

        1. Adult patients whose operation date has been deferred

        2. Patients who did not have had an operation date

        3. Patients who have been operating on during the month before

      Each group will receive a twofold questionnaire:

      Part I: Hospital Anxiety and Depression Scale (HADS), a robust questionnaire used for
      hospitalized and non-hospitalized patients gauging the degree of anxiety and/or depression,
      irrespective of their specific medical condition. All three groups receive the same list of
      questions.

      -Part II: a questionnaire made up specifically for issues concerning the
      medical/psychological/access aspects during the COVID-19 outbreak. Each of the three groups
      will receive a questionnaire, adapted to the group they are assigned to.

      The questionnaires will be delivered by the use of Qualtrics or on paper. Timing and mode of
      presentation (Qualtrics or fill-in paper on admission) of the questionnaire will depend on
      the length of the quarantine measures.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)
time frame: 10 minutes
description: The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
measure: Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit
time frame: 10 minutes
description: The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.
measure: Reduced access to medical and psychological help
time frame: 10 minutes
description: The occurrence of reduced access to medical and psychological help by means of an adjusted survey.
arm group label: operation deferred
arm group type: Other
description: Adult patients whose operation date has been deferred due to the pandemic
arm group label: no operation date
arm group type: Other
description: Patients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started
arm group label: postoperative consultation deferred
arm group type: Other
description: Patients who have been operating on during the month before the pandemic
intervention type: Behavioral
intervention name: HADS
description: Hospital Anxiety and Depression Scale
arm group label: no operation date
arm group label: operation deferred
arm group label: postoperative consultation deferred
other name: questionnaire
intervention type: Behavioral
intervention name: a survey
description: made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak
arm group label: no operation date
arm group label: operation deferred
arm group label: postoperative consultation deferred
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jan Nijs, MD
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
last name: Mark La Meir, Phd, MD
role: Study Director
affiliation: Universitair Ziekenhuis Brussel
last name: Ashley Welch, MD
role: Study Chair
affiliation: Universitair Ziekenhuis Brussel
last name: Veerle Van Mossevelde, Data Nurse
phone: +3224763134
email: veerle.vanmossevelde@uzbrussel.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Veerle Van Mossevelde
investigator title: Data Nurse
mesh term: COVID-19
mesh term: Anxiety Disorders
mesh term: Stress, Psychological