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NCT Number: NCT03798574

The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults

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.

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Key information

Conditions

Meningococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Neisseria Infection Neisseria Meningitis Sepsis Neisseriaceae Infections

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital at Westmead, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 15 to 24 years 11 months at time of IMD admission
  • Hospitalised IMD case from 1st January 2006 -with serogroup B or non-B IMD, confirmed by culture or polymerase chain reaction (PCR) in blood or CSF.
  • Healthy controls aged 17 to 34 years 11 months at the time of assessment.

Exclusion criteria

  • Individuals who are not fluent with the English language.
  • Control participants with a history of meningitis, encephalitis, or meningococcal disease, intellectual disability, intracranial pathology (eg. traumatic brain injury) that may impact on cognitive functioning, or significant vision and/or hearing loss that may impact on the validity or reliability of the neurocognitive assessment.

Treatment and study plan

Primary outcomes

  1. Difference in intellectual functioning between cases and controls

    Time frame: Between 2 to 10 years post IMD admission

    Measured by the Full Scale intelligence quotient (IQ) score obtained from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)

  2. Difference in quality of life between cases and controls

    Time frame: Between 2 to 10 years post IMD admission

    Measured by the overall multi-attribute health utility score obtained from the Health Utilities Index Mark 3 (HUI3)-15Q self-report.

Secondary outcomes

  1. Difference in academic achievement between cases and controls.

    Time frame: Between 2 to 10 years post IMD admission

    Measured by Wechsler Individual Achievement Test - Second Edition (WIAT-II)

  2. Difference in memory (verbal and visual) between cases and controls.

    Time frame: Between 2 to 10 years post IMD admission

    Measured by Verbal Learning and Design Memory subtests from the Wide Range Assessment of Memory and Learning, Second Edition (WRAML2)

  3. Difference in executive functioning between cases and controls.

    Time frame: Between 2 to 10 years post IMD admission

    Measured by Delis-Kaplan Executive Function System (D-KEFS)

  4. Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire

    Time frame: Between 2 to 10 years post IMD admission

    Assessed through BRIEF self-report questionnaire (parent and/or self-report)

  5. Difference in the frequency of psychiatric disorders between cases and controls.

    Time frame: Between 2 to 10 years post IMD admission

    Assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0)

  6. Difference in psychological functioning between cases and controls.

    Time frame: Between 2 to 10 years post IMD admission

    Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) (self-report)

  7. Difference in behavioral ratings between cases and controls

    Time frame: Between 2 to 10 years post IMD admission

    Measured by Conners Rating Scales (parent and/or self-report)

  8. Difference in health and disability functioning between cases and controls

    Time frame: Between 2 to 10 years post IMD admission

    Measured by the International Classification of Functioning, Disability and Health (ICF) tool.

  9. Difference in hearing threshold levels between cases and controls

    Time frame: Between 2 to 10 years post IMD admission

    Measured by pure tone audiometry.

  10. Difference in health status between cases and controls

    Time frame: Between 2 to 10 years post IMD admission

    The EQ-5D-5L will be completed to measure participant's health status and to calculate quality adjusted life years (QALYS) lost.

  11. 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)

    IMD cases only: Lifetime dollar costs.

  12. 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

    A subset of IMD cases will participate in a semi-structured interview.

  13. Carer's experience assessed through the Carer Experience Scale

    Time frame: Between 2 to 10 years post IMD admission

    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.

  14. Carer's experience assessed through ICEpop CAPability questionnaires

    Time frame: Between 2 to 10 years post IMD admission

    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.

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Registry information

Acronym: AMEND

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2019
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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