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STAAR: a randomised controlled trial of electronic adherence monitoring with reminder alarms and feedback to improve clinical outcomes for children with asthma
  1. Robert W Morton1,2,
  2. Heather E Elphick1,2,
  3. Alan S Rigby3,
  4. William J Daw1,2,
  5. David A King1,
  6. Laurie J Smith2,
  7. Mark L Everard4
  1. 1Academic Unit of Child Health, University of Sheffield, Sheffield, South Yorkshire, UK
  2. 2Department of Respiratory Medicine, Sheffield Children's Hospital, Sheffield, South Yorkshire, UK
  3. 3Hull York Medical School, University of Hull, Hull, Yorkshire, UK
  4. 4School of Paediatrics and Child Health, Princess Margaret Hospital University of Western Australia, Perth, Western Australia, Australia
  1. Correspondence to Dr Robert W Morton, Sheffield Children's Hospital, Western Bank, Sheffield, South Yorkshire S10 2TH, UK; rwmorton99{at}gmail.com

Abstract

Background Suboptimal adherence to inhaled steroids is common in children with asthma and is associated with poor disease control, reduced quality of life and even death. Previous studies using feedback of electronically monitored adherence data have demonstrated improved adherence, but have not demonstrated a significant impact on clinical outcomes. The aim of this study was to determine whether introduction of this approach into routine practice would result in improved clinical outcomes.

Methods Children with asthma aged 6–16 years were randomised to the active intervention consisting of electronic adherence monitoring with daily reminder alarms together with feedback in the clinic regarding their inhaled corticosteroid (ICS) use or to the usual care arm with adherence monitoring alone. All children had poorly controlled asthma at baseline, taking ICS and long-acting β-agonists. Subjects were seen in routine clinics every 3 months for 1 year. The primary outcome was the Asthma Control Questionnaire (ACQ) score. Secondary outcomes included adherence and markers of asthma morbidity.

Results 77 of 90 children completed the study (39 interventions, 38 controls). Adherence in the intervention group was 70% vs 49% in the control group (p≤0.001). There was no significant difference in the change in ACQ, but children in the intervention group required significantly fewer courses of oral steroids (p=0.008) and fewer hospital admissions (p≤0.001).

Conclusions The results indicate that electronic adherence monitoring with feedback is likely to be of significant benefit in the routine management of poorly controlled asthmatic subjects.

Trial registration number NCT02451709; pre-result.

  • Paediatric asthma
  • Asthma
  • Psychology

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Footnotes

  • Twitter Follow David King at @davidking83

  • Contributors RWM wrote the protocol for the study, applied for and secured ethical approval for the study and applied for and secured funding for the study. He recruited participants, carried out study visits, recorded the results and wrote and edited the manuscript. HEE helped write the protocol, helped apply for funding, supervised the implementation of the study and helped write and edit the manuscript. ASR helped write the protocol, performed all the statistical analysis for the study and helped write and edit the manuscript. WJD carried out study visits and helped edit the manuscript. DAK helped apply for ethical approval, helped apply for funding, recruited participants, carried out study visits and helped edit the manuscript. LJS recorded and analysed the lung function for all the participants in the study and helped edit the manuscript. MLE devised the concept of the study, wrote the protocol and helped write and edit the manuscript.

  • Funding This study was funded by the Sheffield Children's Hospital Charity.

  • Competing interests None declared.

  • Ethics approval South Yorkshire Research Ethics Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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