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.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  NCT01529697; Pre-results.
authors.affiliation: Clinical Research Centre, Smurfit Building Beaumont Hospital, Royal College of Surgeons Ireland, Dublin, Ireland.
authors.forename: Imran
authors.initials: I
authors.lastname: Sulaiman
authors.affiliation: Clinical Research Centre, Smurfit Building Beaumont Hospital, Royal College of Surgeons Ireland, Dublin, Ireland.
authors.forename: Elaine
authors.initials: E
authors.lastname: Mac Hale
authors.affiliation: Department of Bioengineering, Trinity College, Dublin, Ireland.
authors.forename: Martin
authors.initials: M
authors.lastname: Holmes
authors.affiliation: Department of Bioengineering, Trinity College, Dublin, Ireland.
authors.forename: Cian
authors.initials: C
authors.lastname: Hughes
authors.affiliation: Department of Bioengineering, Trinity College, Dublin, Ireland.
authors.forename: Shona
authors.initials: S
authors.lastname: D'Arcy
authors.affiliation: Department of Bioengineering, Trinity College, Dublin, Ireland.
authors.forename: Terrence
authors.initials: T
authors.lastname: Taylor
authors.affiliation: Department of Bioengineering, Trinity College, Dublin, Ireland.
authors.forename: Viliam
authors.initials: V
authors.lastname: Rapcan
authors.affiliation: Clinical Research Centre, Smurfit Building Beaumont Hospital, Royal College of Surgeons Ireland, Dublin, Ireland.
authors.forename: Frank
authors.initials: F
authors.lastname: Doyle
authors.affiliation: Clinical Research Centre, Smurfit Building Beaumont Hospital, Royal College of Surgeons Ireland, Dublin, Ireland.
authors.forename: Aoife
authors.initials: A
authors.lastname: Breathnach
authors.affiliation: Clinical Research Centre, Smurfit Building Beaumont Hospital, Royal College of Surgeons Ireland, Dublin, Ireland.
authors.forename: Jansen
authors.initials: J
authors.lastname: Seheult
authors.affiliation: Department of Respiratory Medicine, University Hospital Cork, Cork, Ireland.
authors.forename: Desmond
authors.initials: D
authors.lastname: Murphy
authors.affiliation: Department of Respiratory Medicine, University Hospital Cork, Cork, Ireland.
authors.forename: Eoin
authors.initials: E
authors.lastname: Hunt
authors.affiliation: Department of Respiratory Medicine, Adelaide and Meath Hospital, Dublin, Ireland.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Lane
authors.affiliation: Department of Respiratory Medicine, Adelaide and Meath Hospital, Dublin, Ireland.
authors.forename: Abhilash
authors.initials: A
authors.lastname: Sahadevan
authors.affiliation: Clinical Research Centre, Smurfit Building Beaumont Hospital, Royal College of Surgeons Ireland, Dublin, Ireland.
authors.forename: Gloria
authors.initials: G
authors.lastname: Crispino
authors.affiliation: Department of Medicine, Johns Hopkins University Hospital, Baltimore, Maryland, USA.
authors.forename: Greg
authors.initials: G
authors.lastname: Diette
authors.affiliation: Department of Bioengineering, Trinity College, Dublin, Ireland.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Killane
authors.affiliation: Department of Bioengineering, Trinity College, Dublin, Ireland.
authors.forename: Richard B
authors.initials: RB
authors.lastname: Reilly
authors.affiliation: Department of Respiratory Medicine, Royal College of Surgeons Ireland, Dublin, Ireland.
authors.forename: Richard W
authors.initials: RW
authors.lastname: Costello
mesh_terms: D000280:Administration, Inhalation; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001249:Asthma; D055615:Electrical Equipment and Supplies; D004581:Electronics; D005246:Feedback; D006801:Humans; D055118:Medication Adherence; D009330:Nebulizers and Vaporizers; D011446:Prospective Studies; D012107:Research Design; D012720:Severity of Illness Index; D016037:Single-Blind Method
chemical_list: D018927:Anti-Asthmatic Agents
keywords: MEDICAL EDUCATION & TRAINING