Clinical trial NCT03798574: The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults
Official title: The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningococcal Infections
Neisseria Meningitis Sepsis
Neisseria Infection
Lead sponsor: University of Adelaide
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 98
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population sample from participating Australian hospitals in Adelaide, Melbourne, Perth, and Sydney.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in intellectual functioning between cases and controls
timeFrame: Between 2 to 10 years post IMD admission
measure: Difference in quality of life between cases and controls
timeFrame: Between 2 to 10 years post IMD admission
Secondary outcomes:
measure: Difference in academic achievement between cases and controls.
timeFrame: Between 2 to 10 years post IMD admission
measure: Difference in memory (verbal and visual) between cases and controls.
timeFrame: Between 2 to 10 years post IMD admission
measure: Difference in executive functioning between cases and controls.
timeFrame: Between 2 to 10 years post IMD admission
measure: Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire
timeFrame: Between 2 to 10 years post IMD admission
measure: Difference in the frequency of psychiatric disorders between cases and controls.
timeFrame: Between 2 to 10 years post IMD admission
measure: Difference in psychological functioning between cases and controls.
timeFrame: Between 2 to 10 years post IMD admission
measure: Difference in behavioral ratings between cases and controls
timeFrame: Between 2 to 10 years post IMD admission
measure: Difference in health and disability functioning between cases and controls
timeFrame: Between 2 to 10 years post IMD admission
measure: Difference in hearing threshold levels between cases and controls
timeFrame: Between 2 to 10 years post IMD admission
measure: Difference in health status between cases and controls
timeFrame: Between 2 to 10 years post IMD admission
measure: To estimate the lifetime costs associated with survival following IMD
timeFrame: From time of admission up to time of follow up (2 to 10 years post IMD admission)
measure: Explore adolescents and young people's experience of their hospital presentation, admission, and recovery from IMD
timeFrame: Between 2 to 10 years post IMD admission
measure: Carer's experience assessed through the Carer Experience Scale
timeFrame: Between 2 to 10 years post IMD admission
measure: Carer's experience assessed through ICEpop CAPability questionnaires
timeFrame: Between 2 to 10 years post IMD admission
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Adelaide
country: Australia
facility: Women's and Children's Hosptial
state: South Australia
city: Clayton
country: Australia
facility: Monash Children's Hospital, Melbourne
state: Victoria
city: Nedlands
country: Australia
facility: Perth Children's Hospital
state: Western Australia
Study officials:
affiliation: University of Adelaide
name: Helen Marshall
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marshall H, McMillan M, Wang B, Booy R, Afzali H, Buttery J, Blyth CC, Richmond P, Shaw D, Gordon D, Barton B. AMEND study protocol: a case-control study to assess the long-term impact of invasive meningococcal disease in Australian adolescents and young adults. BMJ Open. 2019 Dec 29;9(12):e032583. doi: 10.1136/bmjopen-2019-032583.