Condition category
Respiratory
Date applied
24/06/2008
Date assigned
19/08/2008
Last edited
20/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

GP practices

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2008

Overall trial end date

30/11/2009

Reason abandoned

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

Patient

Age group

Child

Gender

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

United Kingdom

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20687917
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24899217

Publication citations

  1. Protocol

    Hammersley VS, Walker S, Elton R, Sheikh A, Protocol for the adolescent hayfever trial: cluster randomised controlled trial of an educational intervention for healthcare professionals for the management of school-age children with hayfever., Trials, 2010, 11, 84, doi: 10.1186/1745-6215-11-84.

  2. Results

    Hammersley VS, Elton RA, Walker S, Hansen CH, Sheikh A, Adolescent seasonal allergic rhinitis and the impact of health-care professional training: cluster randomised controlled trial of a complex intervention in primary care, NPJ Prim Care Respir Med, 2014, 24, 14012, doi: 10.1038/npjpcrm.2014.12.

Additional files

Editorial Notes