Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN)

D Morrison, S Wyke, K Saunderson, A McConnachie, K Agur, R Chaudhuri, M Thomas, N C Thomson, L Yardley, F S Mair, D Morrison, S Wyke, K Saunderson, A McConnachie, K Agur, R Chaudhuri, M Thomas, N C Thomson, L Yardley, F S Mair

Abstract

Objective: To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (Living Well with Asthma) to support self-management.

Design and setting: Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care.

Participants: Adults (age≥16 years) with physician diagnosed, symptomatic asthma (Asthma Control Questionnaire (ACQ) score ≥1). People with unstable asthma or other lung disease were excluded.

Intervention: 'Living Well with Asthma' is a desktop/laptop compatible interactive website designed with input from asthma/ behaviour change specialists, and adults with asthma. It aims to support optimal medication management, promote use of action plans, encourage attendance at asthma reviews and increase physical activity.

Outcome measures: Primary outcomes were recruitment/retention, website use, ACQ and mini-Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included patient activation, prescribing, adherence, spirometry, lung inflammation and health service contacts after 12 weeks. Blinding postrandomisation was not possible.

Results: Recruitment target met. 51 participants randomised (25 intervention group). Age range 16-78 years; 75% female; 28% from most deprived quintile. 45/51 (88%; 20 intervention group) followed up. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 0.89; p=0.136). No adverse events.

Conclusions: Recruitment and retention confirmed feasibility; trends to improved outcomes suggest use of Living Well with Asthma may improve self-management in adults with asthma and merits further development followed by investigation in a phase 3 trial.

Trial registration number: ISRCTN78556552; Results.

Keywords: Adherence; Internet; PRIMARY CARE; behaviour change; complex intervention.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Flow of participants through study. *Actual search terms refined iteratively through recruitment (see online supplementary data file for detail). ACQ, Asthma Control Questionnaire score; FeNO, fractional exhaled nitric oxide; NHS, National Health Service.

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