Welcome to the PLEASANT study website
Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term
The PLEASANT study is a cluster randomised controlled trial investigating the effect of a postal intervention, sent to parents/carers of school age asthmatic children during the summer holidays, in reducing unscheduled medical contacts in September following return to school.
Why is this study taking place?
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 that this might be caused by the return back to school, suddenly mixing with other children again and picking up bugs which can affect their asthma.
During the school summer holidays there is a drop in the number of prescriptions for asthma medications. It has been suggested that 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.
What does the study involve?
This trial will involve the recruitment of 140 General Practices (GPs) in the UK. GPs will be randomised to either: a) intervention arm (sending out the postal intervention to parents of all their school age children with asthma), or b) usual care (no postal intervention).
The primary objective of the study is to assess whether the intervention reduces the proportion of patients with unscheduled medical contacts in September. The study will also include a cost effectiveness analysis of the intervention.
GPs will be recruited by the Clinical Practice Research Datalink (CPRD), who will also be collecting and providing the data for the trial. We anticipate collecting observational data from around 14,000 children.
Please note we are only able to recruit general practices that are on the Vision system and part of the CPRD.
When will the study take place?
Recruitment of general practices is due to start in January 2013 and all 140 practices will be recruited by July 2013. The intervention will be sent out in July/August 2013, and final data will be collected in September 2014.
Trial Registration
The PLEASANT study is registered with Controlled Clinical Trials: ISRCTN03000938
The PLEASANT study is also registered on the UK Clinical Trials Gateway and the UK Clinical Research Network.
PLEASANT Team
| Name & Role | Location | Phone | |
|---|---|---|---|
| Dr Steven A Julious, Chief Investigator | Medical Statistics Group, ScHARR, University of Sheffield | s.a.julious@sheffield.ac.uk | (0114) 222 0709 |
| Dr Michelle Horspool, Trial Manager | Clinical Trials Research Unit, ScHARR, University of Sheffield | m.horspool@sheffield.ac.uk | (0114) 222 4303 |
| Dr Cindy Cooper, CTRU Director | Clinical Trials Research Unit, ScHARR, University of Sheffield | c.l.cooper@sheffield.ac.uk | (0114) 222 0743 |
| Dr Henry Smithson, General Practitioner | Academic Unit of Primary Medical Care, University of Sheffield | henry.smithson@sheffield.ac.uk | (0114) 222 2210 |
| Dr Jonathan Boote, Lead for Patient & Public Involvement | NIHR Research Design Service for Yorkshire and Humber, ScHARR, University of Sheffield | j.boote@sheffield.ac.uk | (0114) 222 0892 |
| Dr Tjeerd van Staa, Head of CPRD Research | Clinical Practice Research Datalink, MHRA, London | tjeerd.vanstaa@mhra.gsi.gov.uk | (020) 3080 6019 |
| Gerry McCann, Business Development & Clinical Trials Manager | Clinical Practice Research Datalink, MHRA, London | gerard.mccann@mhra.gsi.gov.uk | (020) 3080 6019 |
| Ms Sarah Davis, Health Economist | Health Economics and Decision Sciences, ScHARR, University of Sheffield | s.davis@sheffield.ac.uk | (0114) 222 5209 |
| Dr Paul Norman, Health Psychologist | Department of Psychology, University of Sheffield | p.norman@sheffield.ac.uk | (0114) 222 6505 |
| Dr Heather Elphick, Consultant in Paediatric Respiratory Medicine | Paediatric Respiratory Medicine, Sheffield Children's Hospital | heather.elphick@sch.nhs.uk | (0114) 226 0733 |
| Mr David White, Research Assistant | Clinical Trials Research Unit, ScHARR, University of Sheffield | d.a.white@sheffield.ac.uk | (0114) 222 0807 |
| Ms Helen Wakefield, Trials Support Officer | Clinical Trials Research Unit, ScHARR, University of Sheffield | h.wakefield@sheffield.ac.uk | (0114) 222 2979 |
| Mr Mike Bradburn, Medical Statistician | Clinical Trials Research Unit, ScHARR, University of Sheffield | m.bradburn@sheffield.ac.uk | (0114) 222 0706 |
| Mr Neil Shephard, Medical Statistician | Clinical Trials Research Unit, ScHARR, University of Sheffield | n.shephard@sheffield.ac.uk | (0114) 222 5203 |
| Dr Amanda Loban, Data Manager | Clinical Trials Research Unit, ScHARR, University of Sheffield | a.loban@sheffield.ac.uk | (0114) 222 2995 |
| Miss Cara Mooney, Research Assistant | Clinical Trials Research Unit, ScHARR, University of Sheffield | c.d.mooney@sheffield.ac.uk | (0114) 222 4308 |
| Mr Ben Sully, Medical Statistician | Medical Statistics Group, ScHARR, University of Sheffield | b.g.sully@sheffield.ac.uk | (0114) 222 0813 |