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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03798574




Registration number
NCT03798574
Ethics application status
Date submitted
23/12/2018
Date registered
10/01/2019
Date last updated
1/03/2019

Titles & IDs
Public title
The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults
Scientific title
The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults
Secondary ID [1] 0 0
HREC/14/WCHN/024
Universal Trial Number (UTN)
Trial acronym
AMEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningococcal Infections 0 0
Neisseria Meningitis Sepsis 0 0
Neisseria Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
IMD Case - No intervention

Control - No intervention

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Between 2 to 10 years post IMD admission
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [1] 0 0
Difference in academic achievement between cases and controls. - Measured by Wechsler Individual Achievement Test - Second Edition (WIAT-II)
Timepoint [1] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [3] 0 0
Difference in executive functioning between cases and controls. - Measured by Delis-Kaplan Executive Function System (D-KEFS)
Timepoint [3] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [5] 0 0
Difference in the frequency of psychiatric disorders between cases and controls. - Assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0)
Timepoint [5] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [6] 0 0
Difference in psychological functioning between cases and controls. - Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) (self-report)
Timepoint [6] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [7] 0 0
Difference in behavioral ratings between cases and controls - Measured by Conners Rating Scales (parent and/or self-report)
Timepoint [7] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [8] 0 0
Difference in health and disability functioning between cases and controls - Measured by the International Classification of Functioning, Disability and Health (ICF) tool.
Timepoint [8] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [9] 0 0
Difference in hearing threshold levels between cases and controls - Measured by pure tone audiometry.
Timepoint [9] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [11] 0 0
To estimate the lifetime costs associated with survival following IMD - IMD cases only: Lifetime dollar costs.
Timepoint [11] 0 0
From time of admission up to time of follow up (2 to 10 years post IMD admission)
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Between 2 to 10 years post IMD admission

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
24 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Women's and Children's Hosptial - Adelaide
Recruitment hospital [3] 0 0
Monash Children's Hospital, Melbourne - Clayton
Recruitment hospital [4] 0 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5006 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03798574
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helen Marshall
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Helen Marshall
Address 0 0
Country 0 0
Phone 0 0
8161 8115
Fax 0 0
Email 0 0
helen.marshall@adelaide.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03798574