STAAR: a randomised controlled trial of electronic adherence monitoring with reminder alarms and feedback to improve clinical outcomes for children with asthma.
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.



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.



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).



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.



NCT02451709; pre-result.
Academic Unit of Child Health, University of Sheffield, Sheffield, South Yorkshire, UK.|Department of Respiratory Medicine, Sheffield Children's Hospital, Sheffield, South Yorkshire, UK.
Robert W
0000-0002-6755-6367
RW
Morton
Academic Unit of Child Health, University of Sheffield, Sheffield, South Yorkshire, UK.|Department of Respiratory Medicine, Sheffield Children's Hospital, Sheffield, South Yorkshire, UK.
Heather E
HE
Elphick
Hull York Medical School, University of Hull, Hull, Yorkshire, UK.
Alan S
0000-0001-8331-3907
AS
Rigby
Academic Unit of Child Health, University of Sheffield, Sheffield, South Yorkshire, UK.|Department of Respiratory Medicine, Sheffield Children's Hospital, Sheffield, South Yorkshire, UK.
William J
WJ
Daw
Academic Unit of Child Health, University of Sheffield, Sheffield, South Yorkshire, UK.
David A
DA
King
Department of Respiratory Medicine, Sheffield Children's Hospital, Sheffield, South Yorkshire, UK.
Laurie J
LJ
Smith
School of Paediatrics and Child Health, Princess Margaret Hospital University of Western Australia, Perth, Western Australia, Australia.
Mark L
ML
Everard
D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D005246:Feedback; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D055118:Medication Adherence; D011788:Quality of Life; D017010:Reminder Systems; D011795:Surveys and Questionnaires
D000305:Adrenal Cortex Hormones
Asthma; Paediatric asthma; Psychology