Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03798574
Registration number
NCT03798574
Ethics application status
Date submitted
23/12/2018
Date registered
10/01/2019
Date last updated
9/03/2023
Titles & IDs
Public title
The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults
Query!
Scientific title
The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults
Query!
Secondary ID [1]
0
0
HREC/14/WCHN/024
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
AMEND
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Meningococcal Infections
0
0
Query!
Neisseria Meningitis Sepsis
0
0
Query!
Neisseria Infection
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Infection
0
0
0
0
Query!
Sexually transmitted infections
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
IMD Case - No intervention
Control - No intervention
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Difference in intellectual functioning between cases and controls
Query!
Assessment method [1]
0
0
Measured by the Full Scale intelligence quotient (IQ) score obtained from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)
Query!
Timepoint [1]
0
0
Between 2 to 10 years post IMD admission
Query!
Primary outcome [2]
0
0
Difference in quality of life between cases and controls
Query!
Assessment method [2]
0
0
Measured by the overall multi-attribute health utility score obtained from the Health Utilities Index Mark 3 (HUI3)-15Q self-report.
Query!
Timepoint [2]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [1]
0
0
Difference in academic achievement between cases and controls.
Query!
Assessment method [1]
0
0
Measured by Wechsler Individual Achievement Test - Second Edition (WIAT-II)
Query!
Timepoint [1]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [2]
0
0
Difference in memory (verbal and visual) between cases and controls.
Query!
Assessment method [2]
0
0
Measured by Verbal Learning and Design Memory subtests from the Wide Range Assessment of Memory and Learning, Second Edition (WRAML2)
Query!
Timepoint [2]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [3]
0
0
Difference in executive functioning between cases and controls.
Query!
Assessment method [3]
0
0
Measured by Delis-Kaplan Executive Function System (D-KEFS)
Query!
Timepoint [3]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [4]
0
0
Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire
Query!
Assessment method [4]
0
0
Assessed through BRIEF self-report questionnaire (parent and/or self-report)
Query!
Timepoint [4]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [5]
0
0
Difference in the frequency of psychiatric disorders between cases and controls.
Query!
Assessment method [5]
0
0
Assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0)
Query!
Timepoint [5]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [6]
0
0
Difference in psychological functioning between cases and controls.
Query!
Assessment method [6]
0
0
Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) (self-report)
Query!
Timepoint [6]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [7]
0
0
Difference in behavioral ratings between cases and controls
Query!
Assessment method [7]
0
0
Measured by Conners Rating Scales (parent and/or self-report)
Query!
Timepoint [7]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [8]
0
0
Difference in health and disability functioning between cases and controls
Query!
Assessment method [8]
0
0
Measured by the International Classification of Functioning, Disability and Health (ICF) tool.
Query!
Timepoint [8]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [9]
0
0
Difference in hearing threshold levels between cases and controls
Query!
Assessment method [9]
0
0
Measured by pure tone audiometry.
Query!
Timepoint [9]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [10]
0
0
Difference in health status between cases and controls
Query!
Assessment method [10]
0
0
The EQ-5D-5L will be completed to measure participant's health status and to calculate quality adjusted life years (QALYS) lost.
Query!
Timepoint [10]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [11]
0
0
To estimate the lifetime costs associated with survival following IMD
Query!
Assessment method [11]
0
0
IMD cases only: Lifetime dollar costs.
Query!
Timepoint [11]
0
0
From time of admission up to time of follow up (2 to 10 years post IMD admission)
Query!
Secondary outcome [12]
0
0
Explore adolescents and young people's experience of their hospital presentation, admission, and recovery from IMD
Query!
Assessment method [12]
0
0
A subset of IMD cases will participate in a semi-structured interview.
Query!
Timepoint [12]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [13]
0
0
Carer's experience assessed through the Carer Experience Scale
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Between 2 to 10 years post IMD admission
Query!
Secondary outcome [14]
0
0
Carer's experience assessed through ICEpop CAPability questionnaires
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Between 2 to 10 years post IMD admission
Query!
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.
Query!
Minimum age
15
Years
Query!
Query!
Maximum age
24
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
31/12/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
98
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
The Children's Hospital at Westmead - Westmead
Query!
Recruitment hospital [2]
0
0
Women's and Children's Hosptial - Adelaide
Query!
Recruitment hospital [3]
0
0
Monash Children's Hospital, Melbourne - Clayton
Query!
Recruitment hospital [4]
0
0
Perth Children's Hospital - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
0
0
5006 - Adelaide
Query!
Recruitment postcode(s) [3]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [4]
0
0
6009 - Nedlands
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Adelaide
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03798574
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Helen Marshall
Query!
Address
0
0
University of Adelaide
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03798574
Download to PDF