Adolescent hayfever and quality of life

ISRCTN	ISRCTN95538067
DOI	https://doi.org/10.1186/ISRCTN95538067
Protocol serial number	CZF/1/40
Sponsor	Chief Scientist Office of the Scottish Executive Health Department (UK)
Funder	Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZF/1/40)

Submission date: 24/06/2008
Registration date: 19/08/2008
Last edited: 20/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Aziz Sheikh
Scientific

Division of Community Health Sciences: GP Section
The University of Edinburgh
20 West Richmond Street
Edinburgh
EH8 9DX
United Kingdom

Phone	+44 (0)131 6514151
Email	aziz.sheikh@ed.ac.uk

Study information

Primary study design	Interventional
Study design	Pragmatic cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Cluster randomised controlled trial of an educational intervention for healthcare professionals into the management of school-age children with hayfever
Study objectives	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
Health condition(s) or problem(s) studied	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(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.
Key secondary outcome measure(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
Completion date	30/11/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	264
Key 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
Key exclusion criteria	1. Unable to give consent 2. Taking part in any other clinical trials involving treatment for allergic rhinitis
Date of first enrolment	01/08/2008
Date of final enrolment	30/11/2009

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Division of Community Health Sciences: GP Section

The University of Edinburgh
Edinburgh
EH8 9DX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/06/2014		Yes	No
Protocol article	protocol	05/08/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes