<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/NCT03798574</url>
  </required_header>
  <id_info>
    <org_study_id>HREC/14/WCHN/024</org_study_id>
    <nct_id>NCT03798574</nct_id>
  </id_info>
  <brief_title>The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults</brief_title>
  <acronym>AMEND</acronym>
  <official_title>The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Adelaide</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Adelaide</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>
      Survivors of invasive meningococcal disease (IMD) experience a range of mild to severe&#xD;
      sequelae that impact upon their quality of life. The majority of studies to date have focused&#xD;
      on the impact of IMD on childhood and very little is known about the impact of the disease on&#xD;
      adolescents and young people.&#xD;
&#xD;
      The aim of this study is to assess the physical, neurocognitive, economic and societal impact&#xD;
      of IMD on adolescents and young adult Australian survivors.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
        1. Adolescents and young adult survivors who are 2 to 10 years post IMD have significantly&#xD;
           poorer outcomes including intellectual functioning and quality of life when compared to&#xD;
           healthy controls.&#xD;
&#xD;
        2. IMD imposes a significant financial burden upon individuals, families and society.&#xD;
&#xD;
        3. Serogroup B disease is associated with an increased risk of sequelae when compared to&#xD;
           non-B serogroup IMD.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This a multi-centre, case-control mixed-methods study. Survivors of IMD (retrospective and&#xD;
      prospective cases) and non-IMD healthy controls will be invited to participate in the study.&#xD;
&#xD;
      Retrospective IMD cases admitted in the previous 10 years will be identified through each of&#xD;
      the participating hospitals (paediatric and adult hospitals). During the course of the study&#xD;
      prospective recruitment of IMD cases will also occur at participating hospitals.&#xD;
      Meningococcal foundations/groups will also be approached and asked to advertise and conduct a&#xD;
      mail out to their members to inform them about the study.&#xD;
&#xD;
      Healthy controls will be prospectively recruited by &quot;snowballing technique&quot; whereby enrolled&#xD;
      IMD cases will be asked to distribute a study information sheet to their healthy&#xD;
      friends/acquaintances who are approximately the same age. Control participants may also be&#xD;
      identified from databases at each participating site or through community advertising.&#xD;
&#xD;
      Enrolled cases will undergo a neurocognitive, psychological and physical examination 2 - 10&#xD;
      years post IMD admission. A subset of IMD cases will be invited to participate in a&#xD;
      semi-structured interview. Controls will also undergo neurocognitive, psychological and&#xD;
      physical examination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in intellectual functioning between cases and controls</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Measured by the Full Scale intelligence quotient (IQ) score obtained from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in quality of life between cases and controls</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Measured by the overall multi-attribute health utility score obtained from the Health Utilities Index Mark 3 (HUI3)-15Q self-report.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in academic achievement between cases and controls.</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Measured by Wechsler Individual Achievement Test - Second Edition (WIAT-II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in memory (verbal and visual) between cases and controls.</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Measured by Verbal Learning and Design Memory subtests from the Wide Range Assessment of Memory and Learning, Second Edition (WRAML2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in executive functioning between cases and controls.</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Measured by Delis-Kaplan Executive Function System (D-KEFS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Assessed through BRIEF self-report questionnaire (parent and/or self-report)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the frequency of psychiatric disorders between cases and controls.</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in psychological functioning between cases and controls.</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) (self-report)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in behavioral ratings between cases and controls</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Measured by Conners Rating Scales (parent and/or self-report)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in health and disability functioning between cases and controls</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Measured by the International Classification of Functioning, Disability and Health (ICF) tool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in hearing threshold levels between cases and controls</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>Measured by pure tone audiometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in health status between cases and controls</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>The EQ-5D-5L will be completed to measure participant's health status and to calculate quality adjusted life years (QALYS) lost.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To estimate the lifetime costs associated with survival following IMD</measure>
    <time_frame>From time of admission up to time of follow up (2 to 10 years post IMD admission)</time_frame>
    <description>IMD cases only: Lifetime dollar costs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore adolescents and young people's experience of their hospital presentation, admission, and recovery from IMD</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>A subset of IMD cases will participate in a semi-structured interview.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carer's experience assessed through the Carer Experience Scale</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>For those IMD cases with a disability, the primary caregiver and other family members living in the same household will be invited to complete the Carer Experience Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carer's experience assessed through ICEpop CAPability questionnaires</measure>
    <time_frame>Between 2 to 10 years post IMD admission</time_frame>
    <description>For those IMD cases with a disability, the primary caregiver and other family members living in the same household will be invited to complete ICEpop CAPability questionnaire.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">98</enrollment>
  <condition>Meningococcal Infections</condition>
  <condition>Neisseria Meningitis Sepsis</condition>
  <condition>Neisseria Infection</condition>
  <arm_group>
    <arm_group_label>IMD Case</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Population sample from participating Australian hospitals in Adelaide, Melbourne, Perth,&#xD;
        and Sydney.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 15 to 24 years 11 months at time of IMD admission&#xD;
&#xD;
          -  Hospitalised IMD case from 1st January 2006 -with serogroup B or non-B IMD, confirmed&#xD;
             by culture or polymerase chain reaction (PCR) in blood or CSF.&#xD;
&#xD;
          -  Healthy controls aged 17 to 34 years 11 months at the time of assessment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are not fluent with the English language.&#xD;
&#xD;
          -  Control participants with a history of meningitis, encephalitis, or meningococcal&#xD;
             disease, intellectual disability, intracranial pathology (eg. traumatic brain injury)&#xD;
             that may impact on cognitive functioning, or significant vision and/or hearing loss&#xD;
             that may impact on the validity or reliability of the neurocognitive assessment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen Marshall</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Adelaide</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Children's Hospital at Westmead</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's and Children's Hosptial</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Children's Hospital, Melbourne</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perth Children's Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Adelaide</investigator_affiliation>
    <investigator_full_name>Helen Marshall</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Meningococcal Infections</mesh_term>
    <mesh_term>Meningitis</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/NCT03798574
org study id: HREC/14/WCHN/024
nct id: NCT03798574
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Survivors of invasive meningococcal disease (IMD) experience a range of mild to severe
      sequelae that impact upon their quality of life. The majority of studies to date have focused
      on the impact of IMD on childhood and very little is known about the impact of the disease on
      adolescents and young people.

      The aim of this study is to assess the physical, neurocognitive, economic and societal impact
      of IMD on adolescents and young adult Australian survivors.

      Hypothesis:

        1. Adolescents and young adult survivors who are 2 to 10 years post IMD have significantly
           poorer outcomes including intellectual functioning and quality of life when compared to
           healthy controls.

        2. IMD imposes a significant financial burden upon individuals, families and society.

        3. Serogroup B disease is associated with an increased risk of sequelae when compared to
           non-B serogroup IMD.

      Study design:

      This a multi-centre, case-control mixed-methods study. Survivors of IMD (retrospective and
      prospective cases) and non-IMD healthy controls will be invited to participate in the study.

      Retrospective IMD cases admitted in the previous 10 years will be identified through each of
      the participating hospitals (paediatric and adult hospitals). During the course of the study
      prospective recruitment of IMD cases will also occur at participating hospitals.
      Meningococcal foundations/groups will also be approached and asked to advertise and conduct a
      mail out to their members to inform them about the study.

      Healthy controls will be prospectively recruited by "snowballing technique" whereby enrolled
      IMD cases will be asked to distribute a study information sheet to their healthy
      friends/acquaintances who are approximately the same age. Control participants may also be
      identified from databases at each participating site or through community advertising.

      Enrolled cases will undergo a neurocognitive, psychological and physical examination 2 - 10
      years post IMD admission. A subset of IMD cases will be invited to participate in a
      semi-structured interview. Controls will also undergo neurocognitive, psychological and
      physical examination.
observational model: Case-Control
time perspective: Other
measure: Difference in intellectual functioning between cases and controls
time frame: Between 2 to 10 years post IMD admission
description: Measured by the Full Scale intelligence quotient (IQ) score obtained from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)
measure: Difference in quality of life between cases and controls
time frame: Between 2 to 10 years post IMD admission
description: Measured by the overall multi-attribute health utility score obtained from the Health Utilities Index Mark 3 (HUI3)-15Q self-report.
measure: Difference in academic achievement between cases and controls.
time frame: Between 2 to 10 years post IMD admission
description: Measured by Wechsler Individual Achievement Test - Second Edition (WIAT-II)
measure: Difference in memory (verbal and visual) between cases and controls.
time frame: Between 2 to 10 years post IMD admission
description: Measured by Verbal Learning and Design Memory subtests from the Wide Range Assessment of Memory and Learning, Second Edition (WRAML2)
measure: Difference in executive functioning between cases and controls.
time frame: Between 2 to 10 years post IMD admission
description: Measured by Delis-Kaplan Executive Function System (D-KEFS)
measure: Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire
time frame: Between 2 to 10 years post IMD admission
description: Assessed through BRIEF self-report questionnaire (parent and/or self-report)
measure: Difference in the frequency of psychiatric disorders between cases and controls.
time frame: Between 2 to 10 years post IMD admission
description: Assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0)
measure: Difference in psychological functioning between cases and controls.
time frame: Between 2 to 10 years post IMD admission
description: Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) (self-report)
measure: Difference in behavioral ratings between cases and controls
time frame: Between 2 to 10 years post IMD admission
description: Measured by Conners Rating Scales (parent and/or self-report)
measure: Difference in health and disability functioning between cases and controls
time frame: Between 2 to 10 years post IMD admission
description: Measured by the International Classification of Functioning, Disability and Health (ICF) tool.
measure: Difference in hearing threshold levels between cases and controls
time frame: Between 2 to 10 years post IMD admission
description: Measured by pure tone audiometry.
measure: Difference in health status between cases and controls
time frame: Between 2 to 10 years post IMD admission
description: The EQ-5D-5L will be completed to measure participant's health status and to calculate quality adjusted life years (QALYS) lost.
measure: To estimate the lifetime costs associated with survival following IMD
time frame: From time of admission up to time of follow up (2 to 10 years post IMD admission)
description: IMD cases only: Lifetime dollar costs.
measure: Explore adolescents and young people's experience of their hospital presentation, admission, and recovery from IMD
time frame: Between 2 to 10 years post IMD admission
description: A subset of IMD cases will participate in a semi-structured interview.
measure: Carer's experience assessed through the Carer Experience Scale
time frame: Between 2 to 10 years post IMD admission
description: For those IMD cases with a disability, the primary caregiver and other family members living in the same household will be invited to complete the Carer Experience Scale.
measure: Carer's experience assessed through ICEpop CAPability questionnaires
time frame: Between 2 to 10 years post IMD admission
description: For those IMD cases with a disability, the primary caregiver and other family members living in the same household will be invited to complete ICEpop CAPability questionnaire.
arm group label: IMD Case
description: No intervention
arm group label: Control
description: No intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Helen Marshall
role: Principal Investigator
affiliation: University of Adelaide
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: University of Adelaide
investigator full name: Helen Marshall
investigator title: Professor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Meningococcal Infections
mesh term: Meningitis