Achieving Control of Asthma in Children In Africa (ACACIA)

March 8, 2023 updated by: Jonathan Grigg, Queen Mary University of London

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

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

3767

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jonathan Grigg, Professor
  • Phone Number: 0044-(0)2078822206
  • Email: j.grigg@qmul.ac.uk

Study Locations

    • Ashanti
      • Kumasi, Ashanti, Ghana, 00000
        • Kwame Nkrumah University of Science & Technology (KNUST)
      • Blantyre, Malawi, 3
        • Malawi-Liverpool-Wellcome Trust Clinical Research Programme
      • Lagos, Nigeria, 00000
        • Lagos State University College of Medicine
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa
        • University of Kwa-Zulu Natal
      • Kampala, Uganda, 00000
        • Makarere University College of Health Sciences
      • Harare, Zimbabwe, MP167
        • University of Zimbabwe College of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Young people between 12 and 14 years of age.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Malawi group
500 young people with asthma symptoms in Malawi
South Africa group
500 young people with asthma symptoms in South Africa
Uganda group
500 young people with asthma symptoms in Uganda
Nigeria
500 young people with asthma symptoms in Nigeria
Zimbabwe group
500 young people with asthma symptoms in Zimbabwe
Ghana group
500 young people with asthma symptoms in Ghana

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
Percentage of children with asthma or asthma symptoms, based on GAN (Global Asthma Network) screening tool.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.

1 year
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 weeks
environmental factor assessment
Time Frame: 1 year
questions related to the environment of young people with asthma symptoms, reported using descriptive statistics, and percentages
1 year
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
1 year
current treatment of asthma
Time Frame: 1 year
set of questions about current medication, reported using descriptive statistics, and percentages
1 year
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.
1 year
asthma-related time off school
Time Frame: 4 weeks
questions asking about asthma-related time off school, reported as descriptive statistics and percentages
4 weeks
smoking
Time Frame: 1 year
questions assessing active and passive smoking, reported as descriptive statistics and percentages
1 year
FeNO (fractional exhaled nitric oxide)
Time Frame: up to 1 day
FeNO measurements - exhaled Nitric Oxide
up to 1 day
Spirometry FEV1
Time Frame: up to 1 day
FEV1, in liter, and in liter predicted
up to 1 day
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'.
4 weeks
Spirometry FVC
Time Frame: up to 1 day
FVC, in liter, and in liter predicted
up to 1 day
Spirometry FEV1/FVC
Time Frame: up to 1 day
Ratio of FEV1 to FVC
up to 1 day
FEF25-75
Time Frame: up to 1 day
FEF25-75 as percentage
up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jonathan Grigg, Professor, Queen Mary University of London, Blizard Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are currently working on a detailed plan to share the collected data with other researchers in accordance with the existing data protection legislation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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