Objectives of BREATHE
- To produce a breathing training programme for people with asthma (aged 16 to 70 years), incorporating breathing exercise instruction in a digital format (as a DVD or internet download as preferred) with supporting written material.
- To perform a randomised controlled trial to assess the effect of the programme in comparison with usual care, on asthma-related health status, parameters of symptomatic and physiological asthma control and on asthma-related health resource use in people with impaired health status due to asthma over 12 months following the provision of the intervention.
- To perform a randomised controlled trial to assess the effect of the programme in comparison with that of `face to face' physiotherapist-led training of similar content.
- To perform a qualitative process evaluation with 12-15 participants in each arm of the trial, purposively sampled for diversity
- To estimate the cost-effectiveness of the breathing retraining interventions delivered by DVD/download and by face-to-face instruction, using data collected from the trial and from the GP held clinical records.
- To perform an initial `internal pilot' in 2 centres to confirm recruitment targets and protocol viability, and subsequently to extend recruitment to further centres (approximately 20)
Three phases of research are planned in this programme, using different methodologies in each phase.
Phase 1: Development phase-transfer of breathing training programme to audio-visual media: qualitative piloting (pre Fellowship)
During the first 10 months the patient educational materials will be developed by members of the team including, physicians, physiotherapists, health psychologists, communications technology specialists and patient representatives. These will then be piloted in preparation for the RCT.
Phase 2: Randomised controlled clinical trial (RCT) (Pilot Nov 2012-Mar 2013, Main trial April 2013-Dec 2015)
Pragmatic observer blinded 3 arm parallel group randomised controlled trial comparing a breathing training programme delivered through a DVD/ download with a 'face to face' physiotherapist programme and a 'control' arm receiving usual care for adults with asthma and impaired health status.
Phase 3: Health economic evaluation
During the trial we will record resources required to provide the interventions in both DVD/download and the 'face to face' physiotherapy groups. Information will also be collected on all asthma-related healthcare costs for the 1-year follow up period. Respondent questionnaires will be completed at each data collection point to quantify time off work/school; travel costs; and out of pocket expenses.