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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.

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Version 2 2022-01-07, 16:47
Version 1 2019-11-22, 15:25
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posted on 2022-01-07, 16:47 authored by Imran SulaimanImran Sulaiman, Elaine MacHaleElaine MacHale, Martin Holmes, Cian Hughes, Shona D'Arcy, Terrence Taylor, Viliam Rapcan, Frank DoyleFrank Doyle, Aoife Breathnach, Jansen Seheult, Desmond Murphy, Eoin Hunt, Stephen J. Lane, Abhilash Sahadevan, Gloria Crispino, Greg Diette, Isabelle Killane, Richard B. Reilly, Richard CostelloRichard Costello

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.

Funding

Health Research Board of Ireland

History

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The original article is available at http://bmjopen.bmj.com

Published Citation

Sulaiman I, Mac Hale E, Holmes M, Hughes C, D'Arcy S, Taylor T, Rapcan V, Doyle F, Breathnach A, Seheult J, Murphy D, Hunt E, Lane SJ, Sahadevan A, Crispino G, Diette G, Killane I, Reilly RB, Costello RW. 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. BMJ Open. 2016;6(1):e009350

Publication Date

2016-01-04

PubMed ID

26729384

Department/Unit

  • Beaumont Hospital
  • Clinical Research Centre
  • Medicine

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