A protocol for a randomised clinical trial of the effect of providing feedback on inhaler technique and adherence from an electronic device in patients with poorly controlled severe asthma

Imran Sulaiman, Elaine Mac Hale, Martin Holmes, Cian Hughes, Shona D'Arcy, Terrence Taylor, Viliam Rapcan, Frank Doyle, Aoife Breathnach, Jansen Seheult, Desmond Murphy, Eoin Hunt, Stephen J Lane, Abhilash Sahadevan, Gloria Crispino, Greg Diette, Isabelle Killane, Richard B Reilly, Richard W Costello, Imran Sulaiman, Elaine Mac Hale, Martin Holmes, Cian Hughes, Shona D'Arcy, Terrence Taylor, Viliam Rapcan, Frank Doyle, Aoife Breathnach, Jansen Seheult, Desmond Murphy, Eoin Hunt, Stephen J Lane, Abhilash Sahadevan, Gloria Crispino, Greg Diette, Isabelle Killane, Richard B Reilly, Richard W Costello

Abstract

Introduction: In clinical practice, it is difficult to distinguish between patients with refractory asthma from those with poorly controlled asthma, where symptoms persist due to poor adherence, inadequate inhaler technique or comorbid diseases. We designed an audio recording device which, when attached to an inhaler, objectively identifies the time and technique of inhaler use, thereby assessing both aspects of adherence. This study will test the hypothesis that feedback on these two aspects of adherence when passed on to patients improves adherence and helps clinicians distinguish refractory from difficult-to-control asthma.

Methods: This is a single, blind, prospective, randomised, clinical trial performed at 5 research centres. Patients with partially controlled or uncontrolled severe asthma who have also had at least one severe asthma exacerbation in the prior year are eligible to participate. The effect of two types of nurse-delivered education interventions to promote adherence and inhaler technique will be assessed. The active group will receive feedback on their inhaler technique and adherence from the new device over a 3-month period. The control group will also receive training in inhaler technique and strategies to promote adherence, but no feedback from the device. The primary outcome is the difference in actual adherence, a measure that incorporates time and technique of inhaler use between groups at the end of the third month. Secondary outcomes include the number of patients who remain refractory despite good adherence, and differences in the components of adherence after the intervention. Data will be analysed on an intention-to-treat and a per-protocol basis. The sample size is 220 subjects (110 in each group), and loss to follow-up is estimated at 10% which will allow results to show a 10% difference (0.8 power) in adherence between group means with a type I error probability of 0.05.

Trial registration number: NCT01529697; Pre-results.

Keywords: MEDICAL EDUCATION & TRAINING.

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
The study participants are patients with a diagnosis of asthma attending a severe asthma clinic who remain uncontrolled or partially controlled and have experienced at least one severe exacerbation of asthma in the prior year. With no medication change, adherence and inhaler technique are re-enforced over the 12-week monitoring period (INCA, INhaler Compliance Assessment).
Figure 2
Figure 2
A screen shot of the data presented to the patient for discussion of their adherence to the salmeterol/fluticasone Diskus inhaler over the prior month. In this example, the patient has good time of use, in particular in the evening, suggesting they are developing a regular habit of use. However, they show intermittent errors in inhaler technique. In this example, they used the inhaler incorrectly on almost half of all occasions in which the inhaler was used.

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