Achieving Control of Asthma in Children In Africa (ACACIA)
|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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03990402|
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
|Condition or disease|
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 will identify 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 will 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 will also discuss asthma related topics in focus groups. A subset of the participants will furthermore do Spirometry and FeNO testing. In addition to the data collection, the study will develop and test 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 will be promoted by the study, where appropriate.
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||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|
|Actual Study Start Date :||May 16, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
500 young people with asthma symptoms in Malawi
South Africa group
500 young people with asthma symptoms in South Africa
500 young people with asthma symptoms in Uganda
500 young people with asthma symptoms in Nigeria
500 young people with asthma symptoms in Zimbabwe
500 young people with asthma symptoms in Ghana
- Percentage of children with asthma symptoms or asthma [ Time Frame: 12 months ]Percentage of children with asthma or asthma symptoms, based on GAN (Global Asthma Network) screening tool.
- Understanding about Asthma - Questions [ Time Frame: 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.
- Brief Illness Perception Questionnaire [ Time Frame: 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.
- Asthma control test [ Time Frame: 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
- environmental factor assessment [ Time Frame: 1 year ]questions related to the environment of young people with asthma symptoms, reported using descriptive statistics, and percentages
- access to medical care of young people with asthma [ Time Frame: 1 year ]set of questions related to access to medical care, reported using descriptive statistics, and percentages
- current treatment of asthma [ Time Frame: 1 year ]set of questions about current medication, reported using descriptive statistics, and percentages
- Adherence to medication [ Time Frame: 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 [ Time Frame: 4 weeks ]questions asking about asthma-related time off school, reported as descriptive statistics and percentages
- smoking [ Time Frame: 1 year ]questions assessing active and passive smoking, reported as descriptive statistics and percentages
- FeNO (fractional exhaled nitric oxide) [ Time Frame: up to 1 day ]FeNO measurements - exhaled Nitric Oxide
- Spirometry FEV1 [ Time Frame: up to 1 day ]FEV1, in liter, and in liter predicted
- Asthma Control according to GINA (Global INitiative for Asthma) [ Time Frame: 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 [ Time Frame: up to 1 day ]FVC, in liter, and in liter predicted
- Spirometry FEV1/FVC [ Time Frame: up to 1 day ]Ratio of FEV1 to FVC
- FEF25-75 [ Time Frame: up to 1 day ]FEF25-75 as percentage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990402
|Contact: Gioia Mosler, PhD||0044-(0)email@example.com|
|Contact: Jonathan Grigg, Professor||0044-(0)firstname.lastname@example.org|
|Malawi-Liverpool-Wellcome Trust Clinical Research Programme||Recruiting|
|Blantyre, Malawi, 3|
|Contact: Sarah Rylance, MRCPCH,DTM&H|
|University of Kwa-Zulu Natal||Recruiting|
|Durban, KwaZulu Natal, South Africa|
|Contact: Refiloe Masekela, Professor Masekelar@ukzn.ac.za|
|Principal Investigator:||Jonathan Grigg, Professor||Queen Mary University of London, Blizard Institute|