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Open Access Study protocol

‘Help for Hay Fever’, a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial

Terry Porteous1, Sally Wyke2*, Sarah Smith1, Christine Bond1, Jill Francis3, Amanda J Lee1, Richard Lowrie4, Graham Scotland1, Aziz Sheikh5, Mike Thomas6 and Lorraine Smith7

Author Affiliations

1 Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen AB25 2ZD, UK

2 Institute of Health and Wellbeing, College of Social Sciences, Room 227, University of Glasgow, 27 Bute Gardens, G12 8RS Glasgow, UK

3 School of Health Sciences, City University London, Northampton Square, EC1V 0HB London, UK

4 Long Term Conditions and Research Team, Pharmacy and Prescribing Support Unit, Queens Park House, Victoria Infirmary, Glasgow G42 9TY, UK

5 Allergy and Respiratory Research Group, Centre for Population Health Sciences, Medical School, The University of Edinburgh, Doorway 3, Teviot Place, Edinburgh EH8 9AG, UK

6 Primary Care Research, Aldermoor Health Centre, University of Southampton, Aldermoor Close, Southampton SO16 5ST, UK

7 Faculty of Pharmacy, The University of Sydney, Building A15, New South Wales 2006, Australia

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Trials 2013, 14:217  doi:10.1186/1745-6215-14-217

Published: 15 July 2013

Abstract

Background

Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based ‘goal-focused’ intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT).

Methods/Design

A pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome measures relate to changes in symptom severity, productivity, medication adherence and self-efficacy. Quantitative data about accrual, retention and economic measures, and qualitative data about participants’ experiences during the trial will be collected to inform the future RCT.

Discussion

This work will lay the foundations for a definitive RCT of a community pharmacy-based ‘goal-focused’ self-management intervention for people with intermittent allergic rhinitis. Results of the pilot trial are expected to be available in April 2013.

Trial registration

Current Controlled Trials ISRCTN43606442

Keywords:
Respiratory; Allergy; Community pharmacy; Self-care