title: The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA®, in a community pharmacy setting: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Poor adherence to inhaled medication may lead to inadequate symptom control in patients with respiratory disease. In practice it can be difficult to identify poor adherence. We designed an acoustic recording device, the INCA® (INhaler Compliance Assessment) device, which, when attached to an inhaler, identifies and records the time and technique of inhaler use, thereby providing objective longitudinal data on an individual's adherence to inhaled medication. This study will test the hypothesis that providing objective, personalised, visual feedback on adherence to patients in combination with a tailored educational intervention in a community pharmacy setting, improves adherence more effectively than education alone.
  
  
  METHODS
  The study is a prospective, cluster randomised, parallel-group, multi-site study conducted over 6 months. The study is designed to compare current best practice in care (i.e. routine inhaler technique training) with the use of the INCA® device for respiratory patients in a community pharmacy setting. Pharmacies are the unit of randomisation and on enrolment to the study they will be allocated by the lead researcher to one of the three study groups (intervention, comparator or control groups) using a computer-generated list of random numbers. Given the nature of the intervention neither pharmacists nor participants can be blinded. The intervention group will receive feedback from the acoustic recording device on inhaler technique and adherence three times over a 6-month period along with inhaler technique training at each of these times. The comparator group will also receive training in inhaler use three times over the 6-month study period but no feedback on their habitual performance. The control group will receive usual care (i.e. the safe supply of medicines and advice on their use). The primary outcome is the rate of participant adherence to their inhaled medication, defined as the proportion of correctly taken doses of medication at the correct time relative to the prescribed interval. Secondary outcomes include exacerbation rates and quality of life measures. Differences in the timing and technique of inhaler use as altered by the interventions will also be assessed. Data will be analysed on an intention-to-treat and a per-protocol basis. Sample size has been calculated with reference to comparisons to be made between the intervention and comparator clusters and indicates 75 participants per cluster. With an estimated 10 % loss to follow-up we will be able to show a 20 % difference between the population means of the intervention and comparator groups with a power of 0.8. The Type I error probability associated with the test of the null hypothesis is 0.05.
  
  
  CONCLUSIONS
  This clinical trial will establish whether providing personalised feedback to individuals on their inhaler use improves adherence. It may also be possible to enhance the role of pharmacists in clinical care by identifying patients in whom alteration of either therapy or inhaler device is appropriate.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02203266 .
authors.affiliation: School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin 2, Ireland. odwyersm@tcd.ie.|Pharmacy Office, Boots Retail Ireland Limited, Nangor Road, Dublin 12, Ireland. odwyersm@tcd.ie.
authors.forename: Susan Mary
authors.initials: SM
authors.lastname: O'Dwyer
authors.affiliation: Clinical Research Centre, Smurfit Building Beaumont Hospital, RCSI, Dublin, Ireland.
authors.forename: Elaine
authors.initials: E
authors.lastname: MacHale
authors.affiliation: Clinical Research Centre, Smurfit Building Beaumont Hospital, RCSI, Dublin, Ireland.
authors.forename: Imran
authors.initials: I
authors.lastname: Sulaiman
authors.affiliation: Department of Bioengineering, Trinity College Dublin, Dublin 2, Ireland.
authors.forename: Martin
authors.initials: M
authors.lastname: Holmes
authors.affiliation: Department of Bioengineering, Trinity College Dublin, Dublin 2, Ireland.
authors.forename: Cian
authors.initials: C
authors.lastname: Hughes
authors.affiliation: Department of Bioengineering, Trinity College Dublin, Dublin 2, Ireland.
authors.forename: Shona
authors.initials: S
authors.lastname: D'Arcy
authors.affiliation: Department of Bioengineering, Trinity College Dublin, Dublin 2, Ireland.
authors.forename: Viliam
authors.initials: V
authors.lastname: Rapcan
authors.affiliation: Department of Bioengineering, Trinity College Dublin, Dublin 2, Ireland.
authors.forename: Terence
authors.initials: T
authors.lastname: Taylor
authors.affiliation: Royal College of Surgeons in Ireland, 123 St Stephen's Green, Dublin 2, Ireland.
authors.forename: Fiona
authors.initials: F
authors.lastname: Boland
authors.affiliation: Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.
authors.forename: Sinthia
authors.initials: S
authors.lastname: Bosnic-Anticevich
authors.affiliation: Department of Bioengineering, Trinity College Dublin, Dublin 2, Ireland.
authors.forename: Richard B
authors.initials: RB
authors.lastname: Reilly
authors.affiliation: School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin 2, Ireland.
authors.forename: Sheila A
authors.initials: SA
authors.lastname: Ryder
authors.affiliation: Clinical Research Centre, Smurfit Building Beaumont Hospital, RCSI, Dublin, Ireland.|Department of Respiratory Medicine, Royal College of Surgeons in Ireland, 123 St Stephens Green, Dublin 2, Ireland.
authors.forename: Richard W
authors.initials: RW
authors.lastname: Costello
mesh_terms: D000162:Acoustics / Q000295:instrumentation*; D000280:Administration, Inhalation; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D003157:Community Pharmacy Services; D018450:Disease Progression; D004334:Drug Administration Schedule; D004867:Equipment Design; D030141:Feedback, Psychological; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage*; D005938:Glucocorticoids / Q000008:administration & dosage*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007494:Ireland; D008173:Lung Diseases, Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D055118:Medication Adherence; D009330:Nebulizers and Vaporizers; D010353:Patient Education as Topic; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D000068297:Fluticasone-Salmeterol Drug Combination; D005938:Glucocorticoids
keywords: Adherence; Cluster randomised trial; Community pharmacy; INCA® electronic monitor; Inhaler technique; Patient education