Achieving Control of Asthma in Children In Africa
- Conditions
- Asthma
- Registration Number
- NCT03990402
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3767
- aged between a minimum of 12 years, and
- a maximum of 14 years
- Age less than 12 years
- age more than 14 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of children with asthma symptoms or asthma 12 months Percentage of children with asthma or asthma symptoms, based on GAN (Global Asthma Network) screening tool.
- Secondary Outcome Measures
Name Time Method Asthma control test 4 weeks 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
access to medical care of young people with asthma 1 year set of questions related to access to medical care, reported using descriptive statistics, and percentages
Spirometry FEV1/FVC up to 1 day Ratio of FEV1 to FVC
FEF25-75 up to 1 day FEF25-75 as percentage
current treatment of asthma 1 year set of questions about current medication, reported using descriptive statistics, and percentages
smoking 1 year questions assessing active and passive smoking, reported as descriptive statistics and percentages
environmental factor assessment 1 year questions related to the environment of young people with asthma symptoms, reported using descriptive statistics, and percentages
FeNO (fractional exhaled nitric oxide) up to 1 day FeNO measurements - exhaled Nitric Oxide
Spirometry FEV1 up to 1 day FEV1, in liter, and in liter predicted
Understanding about Asthma - Questions 1 year 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.
Asthma Control according to GINA (Global INitiative for Asthma) 4 weeks 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'.
Spirometry FVC up to 1 day FVC, in liter, and in liter predicted
Adherence to medication 1 year set of questions asking about adherence to medication, reported as descriptive statistics and percentages, as well as free text comments.
asthma-related time off school 4 weeks questions asking about asthma-related time off school, reported as descriptive statistics and percentages
Brief Illness Perception Questionnaire 1 year 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.
Trial Locations
- Locations (6)
Makarere University College of Health Sciences
🇺🇬Kampala, Uganda
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
🇲🇼Blantyre, Malawi
Kwame Nkrumah University of Science & Technology (KNUST)
🇬🇭Kumasi, Ashanti, Ghana
Lagos State University College of Medicine
🇳🇬Lagos, Nigeria
University of Zimbabwe College of Health Sciences
🇿🇼Harare, Zimbabwe
University of Kwa-Zulu Natal
🇿🇦Durban, KwaZulu Natal, South Africa