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Theory-based self-management intervention to improve adolescents’ asthma control: a cluster randomised controlled trial protocol
  1. Katherine Harris,
  2. Gioia Mosler,
  3. Jonathan Grigg
  1. Centre for Genomics and Child Health, Queen Mary University of London, London, UK
  1. Correspondence to Dr Katherine Harris; k.harris{at}qmul.ac.uk

Abstract

Introduction Asthma-related morbidity and mortality in the UK is higher than elsewhere in Europe. Although the reasons for this are largely unclear, one explanation could be a higher prevalence of poorly controlled asthma in the UK. Findings from our earlier study found that, in a sample of 766 children with asthma, 45.7% had poorly controlled asthma. Our earlier study also showed that adherence to inhaled corticosteroids was low. Subsequent focus groups identified concerns regarding embarrassment and bullying as barriers to adherence, as well as forgetfulness and incorrect medication beliefs. Following this, a school-based self-management intervention has been developed, aimed to improve asthma control and self-management behaviours.

Methods and analysis The theory-based cluster randomised controlled trial tests an intervention comprising two components: (1) a theatre workshop for all children in years 7 and 8, and (2) self-management workshops for children with asthma. The COM-B model was used to guide the development of the intervention. Questionnaire data will be collected in schools at baseline, immediately post intervention, and 3, 6 and 12 months post intervention. The data collected at 6 months will measure the effect of the intervention against the baseline data. The primary outcome will be asthma control, measured using the Asthma Control Test. All the data will be analysed quantitatively using generalised linear and non-linear mixed effects models.

Ethics and dissemination Ethical approval was obtained by the Queen Mary University of London Ethics Committee on 12 April 2018. Regular meetings will be held with key patient and public stakeholders to plan the key messages from this research. Key messages from the study will also be tweeted via the project twitter account (@SchoolsAsthma). The findings of the study will be submitted for presentation at conferences, as well as written into a manuscript.

Trial registration number MGU0400

  • asthma
  • paediatric thoracic medicine
  • self-management

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors JG is the principal investigator for the study, and planned and provided the overall supervision to the rest of the team. KH contributed to the planning of the study with GM and will be responsible for the data collection and analysis, as well as for disseminating the findings at conferences and in peer-reviewed journals. KH also obtained ethical approval and prepared the manuscript of the protocol. GM contributed to the planning of the study and was responsible for the development of the intervention components, alongside KH. GM also manages the Learning and Outreach team, who also worked on the development of the intervention, and will be responsible for the school liaison and recruitment.

  • Funding This work was supported by Bart’s Charity, grant reference MGU0400. This research was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care North Thames at Bart’s Health National Health Service (NHS) Trust. The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

  • Competing interests None declared.

  • Ethics approval Ethical approval for this study was obtained from Queen Mary University of London Research Ethics Committee on 12 April 2018 (REC reference number: QMERC2017/77).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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