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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
8/01/2019
Date last updated
8/01/2019

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 in 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 in 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 standardised psychometric measures assessing the academic achievement of 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 standardised psychometric measures assessing memory (verbal and visual) of cases and controls. - Measured by 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 standardised psychometric measures assessing executive functioning of 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 behavioral rating scores in cases and controls assessed through BRIEF self-report questionnaire - Assessed through BRIEF self-report questionnaire
Timepoint [4] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [5] 0 0
Difference in behavioral and psychological ratings in cases and controls assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0) - 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 behavioral and psychological problem scales in cases and controls assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) - Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS)
Timepoint [6] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [7] 0 0
Difference in health and disability measures in cases and controls - Health and disability assessment using the International Classification of Functioning, Disability and Health (ICF) tool.
Timepoint [7] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [8] 0 0
Difference in hearing threshold levels in cases and controls - Assessed through pure tone audiometry.
Timepoint [8] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [9] 0 0
Difference in Quality of life (QoL) and carer experience - All participants will also complete the EQ-5D-5L to measure their health status, which will be used to calculate quality adjusted life years (QALYS) lost. For those participants with a disability, the primary caregiver and other family members living in the same household will be invited to complete questionnaires assessing their well-being and carer experience.
Timepoint [9] 0 0
Between 2 to 10 years post IMD admission
Secondary outcome [10] 0 0
To estimate the lifetime costs associated with survival following IMD - Costs from state health databases and Medicare Benefits Schedule (MBS) including Pharmaceutical Benefits Scheme (PBS), and diary.
Timepoint [10] 0 0
From time of admission up to time of follow up (2 to 10 years post IMD admission)
Secondary outcome [11] 0 0
Explore adolescents experience of their hospital presentation, admission, and recovery from IMD - Qualitative interviews (Cases only)
Timepoint [11] 0 0
Between 2 to 10 years post IMD admission

Eligibility
Key inclusion criteria
- Patients aged 15 to 24 years (less than 25 years) 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 (less than 35 years) 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
- Participants who are not fluent with the English language.

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)
SA
Recruitment hospital [1] 0 0
Women's and Children's Hosptial - Adelaide
Recruitment postcode(s) [1] 0 0
5006 - Adelaide

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

Ethics approval
Ethics application status

Summary
Brief summary
Aim of Study:

To assess the clinical, physical, neurocognitive, economic and societal impact on families
from invasive meningococcal disease (IMD) in Australian adolescents and young adults.

Hypothesis:

1. IMD in adolescence and early adulthood has a significant impact on survivors and their
families compared to controls for outcomes such as poorer physical and mental health,
quality of life and educational achievement.

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

3. Serogroup B disease is associated with an increased risk of sequelae.

Study design:

This is a cohort study with survivors of IMD and non-IMD healthy controls invited to be
enrolled 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. To be
eligible for the study IMD is required to be confirmed by either PCR or culture from blood or
cerebrospinal fluid (CSF). 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.

Controls will be selected by "snowballing technique" whereby healthy friends or acquaintances
of the enrolled IMD case will be approached by the enrolled participant and information about
the study provided to them. Control participants may also be identified from databases at
each participating site, through advertising, or meningococcal foundations/group mail out.

An assessment of enrolled cases including neurocognitive, psychological, physical
examination, and qualitative interview will be conducted at 2 - 10 years post IMD admission.
Control cases 17 - 34 years of age 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

No data has been provided for results reporting
Summary results
Not applicable