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Main
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Note: This record shows only 22 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. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN95538067 |
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Date of registration:
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19/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Adolescent hayfever and quality of life
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Scientific title:
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Cluster randomised controlled trial of an educational intervention for healthcare professionals into the management of school-age children with hayfever |
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Date of first enrolment:
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01/08/2008 |
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Target sample size:
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264 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN95538067 |
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Study type:
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Interventional |
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Study design:
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Pragmatic cluster randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Aziz
Sheikh |
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Address:
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Division of Community Health Sciences: GP Section
The University of Edinburgh
20 West Richmond Street
EH8 9DX
Edinburgh
United Kingdom |
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Telephone:
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+44 (0)131 6514151 |
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Email:
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aziz.sheikh@ed.ac.uk |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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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:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Seasonal allergic rhinitis (hayfever)
Respiratory
Vasomotor and allergic rhinitis
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZF/1/40)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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