The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- Difference in intellectual functioning between cases and controls
研究概览
简要总结
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:
- 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.
- IMD imposes a significant financial burden upon individuals, families and society.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Difference in intellectual functioning between cases and controls
时间窗: Between 2 to 10 years post IMD admission
Measured by the Full Scale intelligence quotient (IQ) score obtained from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)
Difference in quality of life between cases and controls
时间窗: Between 2 to 10 years post IMD admission
Measured by the overall multi-attribute health utility score obtained from the Health Utilities Index Mark 3 (HUI3)-15Q self-report.
次要结局
- Difference in psychological functioning between cases and controls.(Between 2 to 10 years post IMD admission)
- Difference in academic achievement between cases and controls.(Between 2 to 10 years post IMD admission)
- Difference in health status between cases and controls(Between 2 to 10 years post IMD admission)
- To estimate the lifetime costs associated with survival following IMD(From time of admission up to time of follow up (2 to 10 years post IMD admission))
- Difference in memory (verbal and visual) between cases and controls.(Between 2 to 10 years post IMD admission)
- Difference in the frequency of psychiatric disorders between cases and controls.(Between 2 to 10 years post IMD admission)
- Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire(Between 2 to 10 years post IMD admission)
- Carer's experience assessed through the Carer Experience Scale(Between 2 to 10 years post IMD admission)
- Difference in executive functioning between cases and controls.(Between 2 to 10 years post IMD admission)
- Difference in behavioral ratings between cases and controls(Between 2 to 10 years post IMD admission)
- Difference in health and disability functioning between cases and controls(Between 2 to 10 years post IMD admission)
- Explore adolescents and young people's experience of their hospital presentation, admission, and recovery from IMD(Between 2 to 10 years post IMD admission)
- Difference in hearing threshold levels between cases and controls(Between 2 to 10 years post IMD admission)
- Carer's experience assessed through ICEpop CAPability questionnaires(Between 2 to 10 years post IMD admission)
研究者
Helen Marshall
Professor
University of Adelaide