Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term: a cluster randomised control trial View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2013-2015

ABSTRACT

Background and study aims In the UK there is a pronounced increase in the number of visits to the doctor by school age children with asthma in September. It is thought that this might be caused by the return to school, when children with asthma will be mixing with other children again and picking up bugs which can affect their asthma and make them poorly. During the summer holidays there is a drop in the number of prescriptions collected. August is a good month to be an asthmatic -– children with asthma are not mixing with many other children and the pollen count is quite low – therefore children with asthma might not take their medication as they should or allow their medication to run low. We hope that a simple postal intervention from the GP can help prevent children with asthma being poorly in September. To see if the intervention works we will ask some GPs to send out the intervention, to the parents of school aged children with asthma, and some GPs will not. We can then compare whether the intervention has had any effect. We will be looking at a number of factors including whether children who get the intervention see their GP less in September. In addition to the number of visits made to their doctor we will be looking at the number of prescriptions children with asthma have and the effect on costs to the NHS. Who can participate? School aged children, 4-16 years, with asthma will be identified by the Clinical Practice Research Datalink (CPRD) and confirmed as eligible by their GP. What does the study involve? 140 General Practices (GPs) will be recruited and randomised to either of two arms, intervention or control (usual care). Practice recruitment and data collection will be done via the Clinical Practice Research Datalink (CPRD); an e-health secure research service that collects anonymised longitudinal data from medical records including primary care. CPRD will identify potential participants based on pre-identified codes and ask the GPs to check this list for eligibility. The intervention practices will send out the postal intervention to those eligible during the last week in July 2013. Control practices need do nothing else. We anticipate approximately 100 participants per average GP site thus we will collect data on approximately 14000 children.The study team will not have access to any patient identifiable data and will receive fully anonymised data from the CPRD. What are the possible benefits and risks of participating? We hope that this study will improve adherence to prescribed medication and scheduled appointments for childhood asthma care and unscheduled appointments seen in September following the return to school. If the study shows positive results we would want this widely known with recommendation that the intervention be used for future management of childhood asthma. We would not expect any potential adverse effects following receipt of the intervention. The trial and subsequent intervention is hoping to optimise usual clinical care and promote adherence to current prescribed medication. GPs and practice staff will undertake on-going monitoring of their patients as per usual clinical care. Where is the study run from? Within general practices in England and Wales (UK) When is study starting and how long is it expected to run for? January 2013 to July 2015 Who is funding the project? NIHR Health Technology Assessment Programme (UK) Who are the main contacts? 1. Dr Steven Julious (s.a.julious@sheffield.ac.uk) 2. Dr Michelle Horspool (m.horspool@sheffield.ac.uk) More... »

URL

http://www.isrctn.com/ISRCTN03000938

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