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Completed

NCT Number: NCT03990402

Achieving Control of Asthma in Children In Africa

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kwame Nkrumah University of Science & Technology (KNUST), Kumasi, Ashanti Region, Ghana

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. environmental factor assessment

    Time frame: 1 year

    questions related to the environment of young people with asthma symptoms, reported using descriptive statistics, and percentages

  5. 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

  6. current treatment of asthma

    Time frame: 1 year

    set of questions about current medication, reported using descriptive statistics, and percentages

  7. 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.

  8. asthma-related time off school

    Time frame: 4 weeks

    questions asking about asthma-related time off school, reported as descriptive statistics and percentages

  9. smoking

    Time frame: 1 year

    questions assessing active and passive smoking, reported as descriptive statistics and percentages

  10. FeNO (fractional exhaled nitric oxide)

    Time frame: up to 1 day

    FeNO measurements - exhaled Nitric Oxide

  11. Spirometry FEV1

    Time frame: up to 1 day

    FEV1, in liter, and in liter predicted

  12. 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'.

  13. Spirometry FVC

    Time frame: up to 1 day

    FVC, in liter, and in liter predicted

  14. Spirometry FEV1/FVC

    Time frame: up to 1 day

    Ratio of FEV1 to FVC

  15. FEF25-75

    Time frame: up to 1 day

    FEF25-75 as percentage

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study 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

Acronym: ACACIA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 19, 2019
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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