Type

Journal Article

Authors

Terence Taylor
Elaine MacHale
Gregory Diette
Jansen Seheult
Rw Costello
Viliam Rapcan
Gloria Crispino
Shona D'Arcy
Desmond Michael Murphy
Martin Holmes
and 3 others

Subjects

Medicine & Nursing

Topics
sample size engineering asthma nurse education clinical feedback randomised trial follow up clinical trial clinical practice biomedical engineering and bioengineering combination therapy long acting agonists persisting symptoms severe exacerbations controlled refractory asthma inhaled corticosteroid

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. (2016)

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.
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Full list of authors on original publication

Terence Taylor, Elaine MacHale, Gregory Diette, Jansen Seheult, Rw Costello, Viliam Rapcan, Gloria Crispino, Shona D'Arcy, Desmond Michael Murphy, Martin Holmes and 3 others

Experts in our system

1
Terence Taylor
Royal College of Surgeons in Ireland
Total Publications: 11
 
2
Elaine MacHale
Royal College of Surgeons in Ireland
Total Publications: 20
 
3
Jansen N Seheult
Royal College of Surgeons in Ireland
Total Publications: 16
 
4
Viliam Rapcan
Trinity College Dublin
Total Publications: 11
 
5
Shona D'Arcy
Royal College of Surgeons in Ireland
Total Publications: 19
 
6
Martin Holmes
Royal College of Surgeons in Ireland
Total Publications: 15