Achieving Control of Asthma in Children In Africa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between a minimum of 12 years, and a maximum of 14 years Exclusion Criteria: Age less than 12 years age more than 14 years

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Malawi group<br>500 young people with asthma symptoms in Malawi | |
| South Africa group<br>500 young people with asthma symptoms in South Africa | |
| Uganda group<br>500 young people with asthma symptoms in Uganda | |
| Nigeria<br>500 young people with asthma symptoms in Nigeria | |
| Zimbabwe group<br>500 young people with asthma symptoms in Zimbabwe | |
| Ghana group<br>500 young people with asthma symptoms in Ghana | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of children with asthma symptoms or asthma | Percentage of children with asthma or asthma symptoms, based on GAN (Global Asthma Network) screening tool. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding about Asthma - Questions | set of questions about asthma knowledge, maximum knowledge score is 13, minimum knowledge score is 0, total range is 13. Higher values represent better knowledge. | 1 year | 
| Brief Illness Perception Questionnaire | Each of the 9 items in the Brief Illness Perception Questionnaire has a minimum score of 0 and a maximum score of 10. The consequences score is the response to item 1. The timeline score is the response to item 2. The personal control scores is the response to item 3. The treatment control score is the response to item 4. The identity score is the response to item 5. The coherence score is the response to item 7. The emotional representation is the response to item 8. Illness concern is measured by item 6. Item 9 is the causal item. Overall score which represents the degree to which the illness is perceived as threatening or benign. To compute that score, reverse score items 3, 4, and 7 and add these to items 1, 2, 5, 6, and 8. A higher score reflects a more threatening view of the illness. The overall score has a minimum score of 0 and a maximum score is 80. | 1 year | 
| Asthma control test | using validated ACT - Asthma Control Test (license by GlaxoSmithKlyne). The minimum score is 5 (poor control of asthma), the maximum score is 25 (complete control of asthma). An ACT score >19 indicates well-controlled asthma | 4 weeks | 
| environmental factor assessment | questions related to the environment of young people with asthma symptoms, reported using descriptive statistics, and percentages | 1 year | 
| access to medical care of young people with asthma | set of questions related to access to medical care, reported using descriptive statistics, and percentages | 1 year | 
| current treatment of asthma | set of questions about current medication, reported using descriptive statistics, and percentages | 1 year | 
| Adherence to medication | set of questions asking about adherence to medication, reported as descriptive statistics and percentages, as well as free text comments. | 1 year | 
| asthma-related time off school | questions asking about asthma-related time off school, reported as descriptive statistics and percentages | 4 weeks | 
| smoking | questions assessing active and passive smoking, reported as descriptive statistics and percentages | 1 year | 
| FeNO (fractional exhaled nitric oxide) | FeNO measurements - exhaled Nitric Oxide | up to 1 day | 
| Spirometry FEV1 | FEV1, in liter, and in liter predicted | up to 1 day | 
| Asthma Control according to GINA (Global INitiative for Asthma) | GINA questionnaire (Global INitiative for Asthma) using four questions, assessing control of asthma symptoms. Outcome is 'well controlled' if none of the four questions is answered 'Yes', 'partly controlled' if one or two of the four questions is answered 'Yes', uncontrolled, if three or four of the four questions is answered 'Yes'. | 4 weeks | 
| Spirometry FVC | FVC, in liter, and in liter predicted | up to 1 day | 
| Spirometry FEV1/FVC | Ratio of FEV1 to FVC | up to 1 day | 
| FEF25-75 | FEF25-75 as percentage | up to 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FeNO, Africa, Spirometry, Asthma Control, ACT, Prevalence