Adolescent hayfever and quality of life
| ISRCTN | ISRCTN95538067 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95538067 |
| Secondary identifying numbers | 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
Not provided at time of registration
Contact information
Prof Aziz Sheikh
Scientific
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 |
|---|---|
| aziz.sheikh@ed.ac.uk |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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 |
| 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 |
Eligibility
| 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 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 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
Edinburgh
EH8 9DX
United Kingdom
Sponsor information
Chief Scientist Office of the Scottish Executive Health Department (UK)
Government
Government
St Andrews House
Edinburgh
ED1 3DG
United Kingdom
| elaine.moir@scotland.gsi.gov.uk | |
| Website | http://www.sehd.scot.nhs.uk/cso |
"ROR" |
https://ror.org/01bw7zm61 |
Funders
Funder type
Charity
Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZF/1/40)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
