Clinical trial NCT03990402: Achieving Control of Asthma in Children In Africa
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: FeNO
Africa
Spirometry
Asthma Control
ACT
Prevalence
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2019-06-19
Enrollment: 3767
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Young people between 12 and 14 years of age.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of children with asthma symptoms or asthma
timeFrame: 12 months
Secondary outcomes:
measure: Understanding about Asthma - Questions
timeFrame: 1 year
measure: Brief Illness Perception Questionnaire
timeFrame: 1 year
measure: Asthma control test
timeFrame: 4 weeks
measure: environmental factor assessment
timeFrame: 1 year
measure: access to medical care of young people with asthma
timeFrame: 1 year
measure: current treatment of asthma
timeFrame: 1 year
measure: Adherence to medication
timeFrame: 1 year
measure: asthma-related time off school
timeFrame: 4 weeks
measure: smoking
timeFrame: 1 year
measure: FeNO (fractional exhaled nitric oxide)
timeFrame: up to 1 day
measure: Spirometry FEV1
timeFrame: up to 1 day
measure: Asthma Control according to GINA (Global INitiative for Asthma)
timeFrame: 4 weeks
measure: Spirometry FVC
timeFrame: up to 1 day
measure: Spirometry FEV1/FVC
timeFrame: up to 1 day
measure: FEF25-75
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Kumasi
country: Ghana
facility: Kwame Nkrumah University of Science & Technology (KNUST)
state: Ashanti
city: Blantyre
country: Malawi
facility: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
city: Lagos
country: Nigeria
facility: Lagos State University College of Medicine
city: Durban
country: South Africa
facility: University of Kwa-Zulu Natal
state: KwaZulu Natal
city: Kampala
country: Uganda
facility: Makarere University College of Health Sciences
city: Harare
country: Zimbabwe
facility: University of Zimbabwe College of Health Sciences
Study officials:
affiliation: Queen Mary University of London, Blizard Institute
name: Jonathan Grigg, Professor
role: PRINCIPAL_INVESTIGATOR
References: