Title: Identifying children who need help taking their asthma medication
Funder: Asthma UK

Abstract: <p>Poor adherence to asthma medications is the single most important reason for treatment failure and is associated with adverse clinical outcomes. We plan to carry out a large scale intervention study. Before we can carry out that study we need to address two important issues: first, how we can identify poor adherence so that the intervention is targeted at the appropriate group; second how adherence relates to clinical outcomes in children. This proposed feasibility study will provide the data necessary for us to implement a successful randomised controlled trial of a theory based intervention.</p> <p>The development of electronic monitoring devices (Smartinhalers<sup>TM</sup>) to capture actual doses taken and technological advances in the performance of these devices affords us the opportunity to accurately record adherence patterns.&nbsp; To date no intervention studies in children have been successful in terms of clinical outcomes and the results of interventions in all groups have been inconsistent. However, in these studies adherence data was based on prescription records or self report both of which over-estimate adherence.&nbsp; We will use Smartinhalers to more accurately identify adherence patterns and children with poor adherence and assess how adherence relates to clinical outcomes.</p> <p>We will recruit 50 children with moderate-severe poorly controlled asthma, under follow up in a tertiary paediatric respiratory clinic prescribed &ge;400mcg/day of budesonide or equivalent. At baseline parameters of asthma control including symptom score, recent exacerbations, lung function, asthma related quality of life and exhaled nitric oxide will be measured. We will ascertain practical and perceptual barriers to adherence using the Beliefs about Medicines Questionnaire (BMQ) and the Medicines Adherence Rating Scale (MARS). Adherence to medication will be measured using Smartinhalers for two periods of 8 to 12 weeks. At the end of each period asthma control will be re-assessed using the same measures as at baseline. This will enable us to assess the feasibility of capturing adherence patterns in children with asthma and how these patterns relate to the various measures of asthma control. We hypothesise that three groups of children will emerge &ndash; those with previously poor adherence whose adherence and subsequently asthma control improves with monitoring; those with poor adherence, confirmed by monitoring and poor control; those with ongoing poor control despite good adherence. The first two groups will be candidates for an adherence intervention. For the latter group consideration of other strategies, including escalation of therapy is indicated.&nbsp;</p> <p>This will be the first study in children to relate accurate adherence data to clinical outcomes. It will enable us to determine which of the assessments of asthma control relates closely to adherence and would be the most suitable endpoint in a larger intervention study. It will provide an estimate of the proportion of children with moderate-severe asthma with poor adherence who would benefit from an intervention and how best to identify these children.</p>


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: RESPIRATORY