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Trial record 74 of 110 for:    test | ( Map: Malawi )

Achieving Control of Asthma in Children In Africa (ACACIA)

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ClinicalTrials.gov Identifier: NCT03990402
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Jonathan Grigg, Queen Mary University of London

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.

Condition or disease
Asthma

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 will identify 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 will 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 will also discuss asthma related topics in focus groups. A subset of the participants will furthermore do Spirometry and FeNO testing. In addition to the data collection, the study will develop and test 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 will be promoted by the study, where appropriate.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
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
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Young people between 12 and 16 years of age.
Criteria

Inclusion Criteria:

  • aged between a minimum of 12 years, and
  • a maximum of 16 years

Exclusion Criteria:

  • Age less than 12 years
  • age more than 16 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990402


Contacts
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Contact: Gioia Mosler, PhD 0044-(0)2078822361 g.mosler@qmul.ac.uk
Contact: Jonathan Grigg, Professor 0044-(0)2078822206 j.grigg@qmul.ac.uk

Locations
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Malawi
Malawi-Liverpool-Wellcome Trust Clinical Research Programme Recruiting
Blantyre, Malawi, 3
Contact: Sarah Rylance, MRCPCH,DTM&H         
South Africa
University of Kwa-Zulu Natal Recruiting
Durban, KwaZulu Natal, South Africa
Contact: Refiloe Masekela, Professor       Masekelar@ukzn.ac.za   
Sponsors and Collaborators
Queen Mary University of London
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Jonathan Grigg, Professor Queen Mary University of London, Blizard Institute

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Responsible Party: Jonathan Grigg, Professor of Paediatric Respiratory and Environmental Medicine, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03990402     History of Changes
Other Study ID Numbers: 269211
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonathan Grigg, Queen Mary University of London:
FeNO
Africa
Spirometry
Asthma Control
ACT
Prevalence

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases