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.
Study Type
OBSERVATIONAL
Enrollment
98
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Women's and Children's Hosptial
Adelaide, South Australia, Australia
Monash Children's Hospital, Melbourne
Clayton, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
Difference in intellectual functioning between cases and controls
Measured by the Full Scale intelligence quotient (IQ) score obtained from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)
Time frame: Between 2 to 10 years post IMD admission
Difference in quality of life between cases and controls
Measured by the overall multi-attribute health utility score obtained from the Health Utilities Index Mark 3 (HUI3)-15Q self-report.
Time frame: Between 2 to 10 years post IMD admission
Difference in academic achievement between cases and controls.
Measured by Wechsler Individual Achievement Test - Second Edition (WIAT-II)
Time frame: Between 2 to 10 years post IMD admission
Difference in memory (verbal and visual) between cases and controls.
Measured by Verbal Learning and Design Memory subtests from the Wide Range Assessment of Memory and Learning, Second Edition (WRAML2)
Time frame: Between 2 to 10 years post IMD admission
Difference in executive functioning between cases and controls.
Measured by Delis-Kaplan Executive Function System (D-KEFS)
Time frame: Between 2 to 10 years post IMD admission
Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire
Assessed through BRIEF self-report questionnaire (parent and/or self-report)
Time frame: Between 2 to 10 years post IMD admission
Difference in the frequency of psychiatric disorders between cases and controls.
Assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0)
Time frame: Between 2 to 10 years post IMD admission
Difference in psychological functioning between cases and controls.
Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) (self-report)
Time frame: Between 2 to 10 years post IMD admission
Difference in behavioral ratings between cases and controls
Measured by Conners Rating Scales (parent and/or self-report)
Time frame: Between 2 to 10 years post IMD admission
Difference in health and disability functioning between cases and controls
Measured by the International Classification of Functioning, Disability and Health (ICF) tool.
Time frame: Between 2 to 10 years post IMD admission
Difference in hearing threshold levels between cases and controls
Measured by pure tone audiometry.
Time frame: Between 2 to 10 years post IMD admission
Difference in health status between cases and controls
The EQ-5D-5L will be completed to measure participant's health status and to calculate quality adjusted life years (QALYS) lost.
Time frame: Between 2 to 10 years post IMD admission
To estimate the lifetime costs associated with survival following IMD
IMD cases only: Lifetime dollar costs.
Time frame: From time of admission up to time of follow up (2 to 10 years post IMD admission)
Explore adolescents and young people's experience of their hospital presentation, admission, and recovery from IMD
A subset of IMD cases will participate in a semi-structured interview.
Time frame: Between 2 to 10 years post IMD admission
Carer's experience assessed through the Carer Experience Scale
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.
Time frame: Between 2 to 10 years post IMD admission
Carer's experience assessed through ICEpop CAPability questionnaires
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.
Time frame: Between 2 to 10 years post IMD admission
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