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Achieving Control of Asthma in Children In Africa

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03990402
Acronym
ACACIA
Enrollment
3767
Registered
2019-06-19
Start date
2019-05-16
Completion date
2022-12-31
Last updated
2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

FeNO, Africa, Spirometry, Asthma Control, ACT, Prevalence

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.

Interventions

None listed

Sponsors

National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
Queen Mary University of London
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of children with asthma symptoms or asthma12 monthsPercentage of children with asthma or asthma symptoms, based on GAN (Global Asthma Network) screening tool.

Secondary

MeasureTime frameDescription
Brief Illness Perception Questionnaire1 yearEach 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 test4 weeksusing 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 assessment1 yearquestions related to the environment of young people with asthma symptoms, reported using descriptive statistics, and percentages
access to medical care of young people with asthma1 yearset of questions related to access to medical care, reported using descriptive statistics, and percentages
current treatment of asthma1 yearset of questions about current medication, reported using descriptive statistics, and percentages
Adherence to medication1 yearset of questions asking about adherence to medication, reported as descriptive statistics and percentages, as well as free text comments.
asthma-related time off school4 weeksquestions asking about asthma-related time off school, reported as descriptive statistics and percentages
Understanding about Asthma - Questions1 yearset of questions about asthma knowledge, maximum knowledge score is 13, minimum knowledge score is 0, total range is 13. Higher values represent better knowledge.
FeNO (fractional exhaled nitric oxide)up to 1 dayFeNO measurements - exhaled Nitric Oxide
Spirometry FEV1up to 1 dayFEV1, in liter, and in liter predicted
Asthma Control according to GINA (Global INitiative for Asthma)4 weeksGINA 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 FVCup to 1 dayFVC, in liter, and in liter predicted
Spirometry FEV1/FVCup to 1 dayRatio of FEV1 to FVC
FEF25-75up to 1 dayFEF25-75 as percentage
smoking1 yearquestions assessing active and passive smoking, reported as descriptive statistics and percentages

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026