Asthma Clinical Trial
— ACACIAOfficial 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
NCT number | NCT03990402 |
Other study ID # | 269211 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 16, 2019 |
Est. completion date | December 31, 2022 |
Verified date | March 2023 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 3767 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 14 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ghana | Kwame Nkrumah University of Science & Technology (KNUST) | Kumasi | Ashanti |
Malawi | Malawi-Liverpool-Wellcome Trust Clinical Research Programme | Blantyre | |
Nigeria | Lagos State University College of Medicine | Lagos | |
South Africa | University of Kwa-Zulu Natal | Durban | KwaZulu Natal |
Uganda | Makarere University College of Health Sciences | Kampala | |
Zimbabwe | University of Zimbabwe College of Health Sciences | Harare |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London | National Institute for Health Research, United Kingdom |
Ghana, Malawi, Nigeria, South Africa, Uganda, Zimbabwe,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | environmental factor assessment | questions related to the environment of young people with asthma symptoms, reported using descriptive statistics, and percentages | 1 year | |
Secondary | 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 | |
Secondary | current treatment of asthma | set of questions about current medication, reported using descriptive statistics, and percentages | 1 year | |
Secondary | 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 | |
Secondary | asthma-related time off school | questions asking about asthma-related time off school, reported as descriptive statistics and percentages | 4 weeks | |
Secondary | smoking | questions assessing active and passive smoking, reported as descriptive statistics and percentages | 1 year | |
Secondary | FeNO (fractional exhaled nitric oxide) | FeNO measurements - exhaled Nitric Oxide | up to 1 day | |
Secondary | Spirometry FEV1 | FEV1, in liter, and in liter predicted | up to 1 day | |
Secondary | 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 | |
Secondary | Spirometry FVC | FVC, in liter, and in liter predicted | up to 1 day | |
Secondary | Spirometry FEV1/FVC | Ratio of FEV1 to FVC | up to 1 day | |
Secondary | FEF25-75 | FEF25-75 as percentage | up to 1 day |
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