Condition category
Respiratory
Date applied
17/10/2012
Date assigned
19/10/2012
Last edited
18/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
The study will start to recruit GPs in January 2013 to enable the intervention to be delivered at the end of July 2013 and final data collection in September 2014.

Who is funding the project?
NIHR Health Technology Assessment Programme

Who are the main contacts?
Dr Steven Julious
s.a.julious@sheffield.ac.uk

Dr Michelle Horspool, Trial Manager
m.horspool@sheffield.ac.uk

Trial website

http://www.shef.ac.uk/scharr/sections/dts/ctru/pleasant

Contact information

Type

Scientific

Primary contact

Dr Steven Julious

ORCID ID

Contact details

Clinical Trials Research Unit
University of Sheffield
School of Health and Related Research
30 Regent Street
Sheffield
S1 4DA
United Kingdom
s.a.julious@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 11/01/10

Study information

Scientific title

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

Acronym

PLEASANT

Study hypothesis

To determine whether a postal intervention will reduce seasonal exacerbation of asthma, and unscheduled NHS contacts, in school aged children associated with the return to school in September.

More details can be found at http://www.hta.ac.uk/project/2912.asp

Ethics approval

Application due for review on 25th October 2012 by South Yorkshire REC

Study design

Cluster randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Condition

Childhood Asthma

Intervention

70 GP practices undertaking the intervention and 70 control practices of “usual care”.

Postal intervention sent to all school aged children with asthma at the start of the school holidays in July vs usual care (no postal intervention)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The proportion of patients aged between 5-16 who have an unscheduled medical contact in September

Secondary outcome measures

1. The proportion of patients who have an unscheduled medical contact in the period September-December
2. The total number of medical contacts (scheduled and unscheduled) per patient in September and in the period September-December
3. The time to first unscheduled medical contact in September and in the period September-December
4. The proportion of patients who have a medical contact (either scheduled or unscheduled) in September and in the period September-December
5. The total number of medical contacts (either scheduled and unscheduled) per patient in September and in the period September-December
6. The time to first medical contact in September and in the period September-December
7. The proportion of patients who have an unscheduled medical contact in September and in the period September-December associated with a respiratory diagnosis
8. The number of unscheduled medical contacts per patient in September and in the period September-December associated with a respiratory diagnosis
10. The number of prescriptions per patient in the month of August
11. The number of prescriptions in the 12 months following the intervention
12. The proportion of patients who have a scheduled medical contact (for example asthma review) in August
13. The proportion of patients who have a scheduled medical contact (for example asthma review) in the 12 months following the intervention.

The above analyses will be undertaken on patients aged 5-16, since asthma is difficult to diagnose in children below this age; patients aged <5 will be analysed separately to these.

Overall trial start date

01/01/2013

Overall trial end date

31/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Children
1. Between 4 and 16 years of age as of 1st September 2012
2. With a coded diagnosis of asthma
3. Who have been prescribed asthma medication in the previous 12 months

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

14000

Participant exclusion criteria

Children
1. Aged 4 and under and 16 and over years of age as of 1st September 2012
2. Who are not considered appropriate for this intervention by their GP
3. With asthma who are not receiving asthma medication
4. With co-existing neoplastic disease

Recruitment start date

01/01/2013

Recruitment end date

31/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Research Unit
Sheffield
S1 4DA
United Kingdom

Sponsor information

Organisation

NHS Sheffield (UK)

Sponsor details

c/o Mr Ian Atkinson
722 Prince of Wales Road
Sheffield
S9 4EU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) 11/01/10

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24041259

Publication citations

  1. Protocol

    Horspool MJ, Julious SA, Boote J, Bradburn MJ, Cooper CL, Davis S, Elphick H, Norman P, Smithson WH, VanStaa T, Preventing and lessening exacerbations of asthma in school-age children associated with a new term (PLEASANT): study protocol for a cluster randomised control trial., Trials, 2013, 14, 297, doi: 10.1186/1745-6215-14-297.

Additional files

Editorial Notes