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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
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 atta...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4716261/ https://www.ncbi.nlm.nih.gov/pubmed/26729384 http://dx.doi.org/10.1136/bmjopen-2015-009350 |
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author | Sulaiman, Imran Mac Hale, Elaine Holmes, Martin Hughes, Cian D'Arcy, Shona Taylor, Terrence Rapcan, Viliam Doyle, Frank Breathnach, Aoife Seheult, Jansen Murphy, Desmond Hunt, Eoin Lane, Stephen J Sahadevan, Abhilash Crispino, Gloria Diette, Greg Killane, Isabelle Reilly, Richard B Costello, Richard W |
author_facet | Sulaiman, Imran Mac Hale, Elaine Holmes, Martin Hughes, Cian D'Arcy, Shona Taylor, Terrence Rapcan, Viliam Doyle, Frank Breathnach, Aoife Seheult, Jansen Murphy, Desmond Hunt, Eoin Lane, Stephen J Sahadevan, Abhilash Crispino, Gloria Diette, Greg Killane, Isabelle Reilly, Richard B Costello, Richard W |
author_sort | Sulaiman, Imran |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4716261 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-47162612016-01-31 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 Sulaiman, Imran Mac Hale, Elaine Holmes, Martin Hughes, Cian D'Arcy, Shona Taylor, Terrence Rapcan, Viliam Doyle, Frank Breathnach, Aoife Seheult, Jansen Murphy, Desmond Hunt, Eoin Lane, Stephen J Sahadevan, Abhilash Crispino, Gloria Diette, Greg Killane, Isabelle Reilly, Richard B Costello, Richard W BMJ Open Respiratory Medicine 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. BMJ Publishing Group 2016-01-04 /pmc/articles/PMC4716261/ /pubmed/26729384 http://dx.doi.org/10.1136/bmjopen-2015-009350 Text en 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/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Respiratory Medicine Sulaiman, Imran Mac Hale, Elaine Holmes, Martin Hughes, Cian D'Arcy, Shona Taylor, Terrence Rapcan, Viliam Doyle, Frank Breathnach, Aoife Seheult, Jansen Murphy, Desmond Hunt, Eoin Lane, Stephen J Sahadevan, Abhilash Crispino, Gloria Diette, Greg Killane, Isabelle Reilly, Richard B Costello, Richard W 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Respiratory Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4716261/ https://www.ncbi.nlm.nih.gov/pubmed/26729384 http://dx.doi.org/10.1136/bmjopen-2015-009350 |
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