- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03990402
Achieving Control of Asthma in Children In Africa (ACACIA)
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Gioia Mosler, PhD
- Phone Number: 0044-(0)2078822361
- Email: g.mosler@qmul.ac.uk
Study Contact Backup
- Name: Jonathan Grigg, Professor
- Phone Number: 0044-(0)2078822206
- Email: j.grigg@qmul.ac.uk
Study Locations
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Ashanti
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Kumasi, Ashanti, Ghana, 00000
- Kwame Nkrumah University of Science & Technology (KNUST)
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Blantyre, Malawi, 3
- Malawi-Liverpool-Wellcome Trust Clinical Research Programme
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Lagos, Nigeria, 00000
- Lagos State University College of Medicine
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KwaZulu Natal
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Durban, KwaZulu Natal, South Africa
- University of Kwa-Zulu Natal
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Kampala, Uganda, 00000
- Makarere University College of Health Sciences
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Harare, Zimbabwe, MP167
- University of Zimbabwe College of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Malawi group
500 young people with asthma symptoms in Malawi
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South Africa group
500 young people with asthma symptoms in South Africa
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Uganda group
500 young people with asthma symptoms in Uganda
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Nigeria
500 young people with asthma symptoms in Nigeria
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Zimbabwe group
500 young people with asthma symptoms in Zimbabwe
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Ghana group
500 young people with asthma symptoms in Ghana
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of children with asthma symptoms or asthma
Time Frame: 12 months
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Percentage of children with asthma or asthma symptoms, based on GAN (Global Asthma Network) screening tool.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Understanding about Asthma - Questions
Time Frame: 1 year
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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.
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1 year
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Brief Illness Perception Questionnaire
Time Frame: 1 year
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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
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Asthma control test
Time Frame: 4 weeks
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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
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4 weeks
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environmental factor assessment
Time Frame: 1 year
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questions related to the environment of young people with asthma symptoms, reported using descriptive statistics, and percentages
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1 year
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access to medical care of young people with asthma
Time Frame: 1 year
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set of questions related to access to medical care, reported using descriptive statistics, and percentages
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1 year
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current treatment of asthma
Time Frame: 1 year
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set of questions about current medication, reported using descriptive statistics, and percentages
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1 year
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Adherence to medication
Time Frame: 1 year
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set of questions asking about adherence to medication, reported as descriptive statistics and percentages, as well as free text comments.
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1 year
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asthma-related time off school
Time Frame: 4 weeks
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questions asking about asthma-related time off school, reported as descriptive statistics and percentages
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4 weeks
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smoking
Time Frame: 1 year
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questions assessing active and passive smoking, reported as descriptive statistics and percentages
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1 year
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FeNO (fractional exhaled nitric oxide)
Time Frame: up to 1 day
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FeNO measurements - exhaled Nitric Oxide
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up to 1 day
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Spirometry FEV1
Time Frame: up to 1 day
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FEV1, in liter, and in liter predicted
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up to 1 day
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Asthma Control according to GINA (Global INitiative for Asthma)
Time Frame: 4 weeks
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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'.
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4 weeks
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Spirometry FVC
Time Frame: up to 1 day
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FVC, in liter, and in liter predicted
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up to 1 day
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Spirometry FEV1/FVC
Time Frame: up to 1 day
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Ratio of FEV1 to FVC
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up to 1 day
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FEF25-75
Time Frame: up to 1 day
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FEF25-75 as percentage
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up to 1 day
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan Grigg, Professor, Queen Mary University of London, Blizard Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 269211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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