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临床试验/NCT03990402
NCT03990402已完成不适用

GHR (Global Health Research) Project:17/63/38 - NIHR (National Institute for Health Research) Global Health Research Group on Improving Asthma Outcomes in African Children at Queen Mary University of London

Queen Mary University of London6 个研究点 分布在 6 个国家目标入组 3,767 人开始时间: 2019年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,767
试验地点
6
主要终点
Percentage of children with asthma symptoms or asthma

研究概览

简要总结

The main aim of the study is to identify altogether 3000 children aged between 12 and 16 years old with asthma symptoms in six sub-Saharan African countries. The study furthermore aims to assess their asthma control, current treatment, knowledge of and attitudes to asthma, as well as the barriers to achieving good asthma control.

详细描述

Asthma prevalence in young people has been rising in several African countries during the last decade, reaching between 10% and 20% in Central Africa, and up to 20% in South Africa. In addition, asthma related mortality in many African countries is high. South Africa has the third highest asthma related mortality rate in the world. Yet to date, a lack of asthma research and research infrastructure means that we do not have the evidence to either inform advocacy or to develop interventions that improve asthma outcomes.

This study aims to collect data about asthma prevalence and to identify existing barriers to effective asthma management of young people in 6 sub-Saharan countries: Malawi, South Africa, Zimbabwe, Uganda, Ghana, and Nigeria. Each of these countries identifies 500 young people with asthma between 12 and 16 years of age through a screening questionnaire in schools. These 3000 young people with asthma symptoms fill in a survey about asthma, including questions around asthma control, current treatment and access to care, asthma knowledge, asthma attitudes, smoking and environmental influences. Some of the participants also discuss asthma related topics in focus groups. A subset of the participants furthermore do Spirometry and FeNO testing. In addition to the data collection, the study develops and tests options for an intervention aimed at improving asthma control, including the adaption of a United Kingdom - based theater play about asthma awareness. The development of WiFi infrastructure and IT solutions is promoted by the study, where appropriate.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • aged between a minimum of 12 years, and
  • a maximum of 14 years

排除标准

  • Age less than 12 years
  • age more than 14 years

结局指标

主要结局

Percentage of children with asthma symptoms or asthma

时间窗: 12 months

Percentage of children with asthma or asthma symptoms, based on GAN (Global Asthma Network) screening tool.

次要结局

  • Asthma control test(4 weeks)
  • access to medical care of young people with asthma(1 year)
  • Spirometry FEV1/FVC(up to 1 day)
  • FEF25-75(up to 1 day)
  • current treatment of asthma(1 year)
  • smoking(1 year)
  • environmental factor assessment(1 year)
  • FeNO (fractional exhaled nitric oxide)(up to 1 day)
  • Spirometry FEV1(up to 1 day)
  • Understanding about Asthma - Questions(1 year)
  • Asthma Control according to GINA (Global INitiative for Asthma)(4 weeks)
  • Spirometry FVC(up to 1 day)
  • Adherence to medication(1 year)
  • asthma-related time off school(4 weeks)
  • Brief Illness Perception Questionnaire(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Grigg

Professor of Paediatric Respiratory and Environmental Medicine

Queen Mary University of London

研究点 (6)

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