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Open Access Highly Accessed Study protocol

A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial

Deborah Morrison1, Sally Wyke2, Neil C Thomson3, Alex McConnachie4, Karolina Agur1, Kathryn Saunderson1, Rekha Chaudhuri3 and Frances S Mair1*

Author Affiliations

1 General Practice & Primary Care, 1 Horselethill Road, Institute of Health & Wellbeing, University of Glasgow, Glasgow G12 9LX, UK

2 Deputy Director, Institute of Health and Wellbeing/Interdisciplinary Research Professor, College of Social Sciences, Rm 204, 25-28 Bute Gardens, University of Glasgow, Glasgow G12 8RS, UK

3 Institute of Infection, Immunity and Inflammation, Gartnavel General Hospital, 1053 Great Western Road, University of Glasgow, Glasgow G12 0YN, UK

4 Robertson Centre for Biostatistics, Boyd Orr Building, University Avenue, University of Glasgow, Glasgow G12 8QQ, UK

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Trials 2014, 15:185  doi:10.1186/1745-6215-15-185

Published: 24 May 2014

Abstract

Background

The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website ‘Living well with asthma’ which has been developed with the aim of promoting self-management behaviors shown to improve outcomes.

Methods/Design

The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status).

Discussion

Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the ‘Living well with asthma’ website.

Trial registration

This trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13.

Keywords:
Asthma; Self-management; Adherence; E-health; Randomized controlled trial; Complex intervention; Inhaled corticosteroids; Behaviour change