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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 14 July 2014
Main ID:  ISRCTN95538067
Date of registration: 19/08/2008
Primary sponsor: Chief Scientist Office of the Scottish Executive Health Department (UK)
Public title: Adolescent hayfever and quality of life N/A
Scientific title: Cluster randomised controlled trial of an educational intervention for healthcare professionals into the management of school-age children with hayfever
Date of first enrolment: Aug 1 2008
Target sample size: 264
Recruitment status: Completed/Not recruiting
Study type:  Interventional
Study design:  Pragmatic cluster randomised controlled trial  
Countries of recruitment
Key inclusion & exclusion criteria
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

Exclusion criteria: 1. Unable to give consent
2. Taking part in any other clinical trials involving treatment for allergic rhinitis

Age minimum:
Age maximum:
Health Condition(s) or Problem(s) studied
Seasonal allergic rhinitis (hayfever)
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.
Primary Outcome(s)
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(s)
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
Secondary ID(s)
Source(s) of Monetary Support
Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZF/1/40)
Secondary Sponsor(s)
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