Contact information
Type
Scientific
Contact name
Prof Aziz Sheikh
ORCID ID
Contact details
Division of Community Health Sciences: GP Section
The University of Edinburgh
20 West Richmond Street
Edinburgh
EH8 9DX
United Kingdom
+44 (0)131 6514151
aziz.sheikh@ed.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CZF/1/40
Study information
Scientific title
Cluster randomised controlled trial of an educational intervention for healthcare professionals into the management of school-age children with hayfever
Acronym
Study hypothesis
The primary aim of this study is to examine the effectiveness of standardised allergy training in promoting disease-specific quality of life of adolescents with hayfever. A one-day short course which focuses specifically on allergic rhinitis and asthma will be delivered to practice nurses in Lothian.
The objectives are:
1. To evaluate the effectiveness of standardised allergy training for health care professionals on adolescent (12 - 18 years) rhinitis-specific quality of life
2. To examine the impact of improving symptoms of hayfever on examination performance of adolescents
3. To assess the change in allergy practice and improvement in confidence, understanding and managing allergy symptoms of trained nurses or doctors
Ethics approval(s)
Lothian Research Ethics Committee, September 2008, ref: 08/S1102/37
Study design
Pragmatic cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
GP practice
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Seasonal allergic rhinitis (hayfever)
Intervention
The randomisation is at the level of the general practice, i.e. the practices are the clusters.
The health care professional intervention is a one-day short course entitled 'Essential Asthma and Allergic Rhinitis' and is run by the charity Education for Health.
The patient intervention is one consultation with a nurse or doctor (both intervention and control groups). In the intervention arm, the nurse or doctor will have attended the training day. In the control arm the nurse or doctor will not have attended the training day.
The control group will also receive usual care and a leaflet on hayfever management (Allergy UK factsheet). Once the trial is complete, control practice staff will be invited to attend the course.
Intervention type
Other
Primary outcome measure
Difference in the validated Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score between the intervention and control groups at baseline and 3 and 6 weeks post-intervention.
Secondary outcome measures
1. Symptom scores, assessed using a visual analogue scale at 3 and 6 weeks post intervention
2. Overall assessment of seasonal allergic rhinitis symptoms compared with the previous season, assessed 6 weeks post intervention
3. Number of general practitioner and practice nurse consultations for hayfever; prescribed (from clinical records) and over-the-counter (from patients) medication data will be collected for cost-effectiveness comparison. Theses will be assessed at end of hayfever period (September 2009)
4. Examination performance, assessed at end of hayfever period (September 2009)
5. Assessment of change in clinical practice on completion of trial
Overall study start date
01/08/2008
Overall study end date
30/11/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Young people (both males and females) aged 12 - 18 years
2. Hayfever, defined by the presence of a documented clinician diagnosis in the patient's health record and any evidence of treatment used for allergic rhinitis
Participant type(s)
Patient
Age group
Child
Lower age limit
12 Years
Upper age limit
18 Years
Sex
Both
Target number of participants
264
Participant exclusion criteria
1. Unable to give consent
2. Taking part in any other clinical trials involving treatment for allergic rhinitis
Recruitment start date
01/08/2008
Recruitment end date
30/11/2009
Locations
Countries of recruitment
Scotland, United Kingdom
Study participating centre
Division of Community Health Sciences: GP Section
The University of Edinburgh
Edinburgh
EH8 9DX
United Kingdom
Sponsor information
Organisation
Chief Scientist Office of the Scottish Executive Health Department (UK)
Sponsor details
St Andrews House
Edinburgh
ED1 3DG
United Kingdom
-
elaine.moir@scotland.gsi.gov.uk
Sponsor type
Government
Website
http://www.sehd.scot.nhs.uk/cso
ROR
Funders
Funder type
Charity
Funder name
Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZF/1/40)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/08/2010 | Yes | No | |
| Results article | results | 05/06/2014 | Yes | No |