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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2023
Source Queen Mary University of London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Queen Mary University of London National Institute for Health Research, United Kingdom

Countries where clinical trial is conducted

Ghana,  Malawi,  Nigeria,  South Africa,  Uganda,  Zimbabwe, 

Outcome

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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