Achieving Control of Asthma in Children In Africa

Asthma Clinical Trial

— ACACIA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990402
• Other study ID #: 269211
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Asthma

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