The effect of an electronic monitoring device with audiovisual reminder function on adherence to inhaled corticosteroids and school attendance in children with asthma: a randomised controlled trial

Summary

Background

Suboptimum adherence to preventive asthma treatment is associated with substantial morbidity and mortality, yet adherence often remains poor. We aimed to investigate whether use of an inhaler with audiovisual reminders leads to improved adherence and asthma outcomes in school-aged children who presented to the emergency department with an asthma exacerbation.

Methods

We did a randomised controlled trial in patients aged 6–15 years who attended the regional emergency department in Auckland, New Zealand with an asthma exacerbation and were on regular inhaled corticosteroids. Using a simple, unrestricted block randomisation with block sizes of 200, we randomly assigned patients to receive an electronic monitoring device for use with their preventer inhaler with the audiovisual reminder functions either enabled to support adherence to inhaled corticosteroids (intervention group) or disabled (control group). Participants were followed up every 2 months for 6 months. The primary outcomes were adherence to preventive inhaled corticosteroids and number of days absent from school for any reason. Asthma control was assessed as a secondary outcome. All analyses were done in the intention-to-treat population. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12613001353785.

Findings

The study took place between May 10, 2010, and Feb 26, 2012. We randomly assigned 220 patients, 110 to the intervention group and 110 to the control group. Median percentage adherence was 84% (10th percentile 54%, 90th percentile 96%) in the intervention group, compared with 30% (8%, 68%) in the control group (p<0·0001). The proportion of days absent from school for any reason was 1·9% (10th percentile 0·0%, 90th percentile 7·9%) in the intervention group and 1·7% (0·0%, 8·6%) in the control group. The change in asthma morbidity score from baseline to 6 months was significantly greater in the intervention group than in the control group (p=0·008), with a reduction of 2·0 points from a mean baseline score of 9·3 (SD 2·2) to 7·3 (2·1) in the intervention group, compared with a reduction of 1·2 points from a baseline of 9·2 (2·5) to 8·0 (2·2) in the control group.

Interpretation

Use of an electronic monitoring device with an audiovisual reminder led to significant improvements in adherence to inhaled corticosteroids in school-aged children with asthma. This intervention could be beneficial for the improvement of asthma control in patients for whom poor asthma control is related to poor adherence.

Funding

Health Research Council of New Zealand and Cure Kids.

Introduction

Asthma is one of the most common chronic diseases in childhood.1, 2, 3 Suboptimum adherence to long-term preventive asthma treatment, such as inhaled corticosteroids, is associated with substantial morbidity and mortality,4, 5 and adherence remains poor.6, 7, 8, 9 Various interventions have been tried to improve adherence, but have shown only small benefits.10, 11 Additionally, studies of adherence interventions in children with asthma are scarce, and many of those that have been done were underpowered to detect differences in clinical asthma outcomes or used subjective methods to monitor adherence.¹²

In the past 15 years, electronic monitoring devices have been introduced for both objective adherence monitoring⁸ and as an adherence aid via reminder systems.13, 14 Electronic monitoring devices are regarded as the gold standard in adherence monitoring because of their objectivity and their ability to provide detailed information about patterns of treatment use. Three randomised controlled trials to investigate electronic monitoring device-based reminder interventions in asthma have been reported.15, 16, 17 In all of these studies, adherence was improved in the reminder group compared with the control groups, but none showed significant differences in clinical asthma outcomes. Possible explanations for these findings include the recruitment of motivated volunteers, use of higher overall doses of inhaled corticosteroids than what the patient might clinically need for asthma control,15, 17 and low participant numbers.¹⁶ Whether the improvements seen in adherence with audiovisual reminders translate into improvements in asthma outcomes therefore remains unknown.

In this study, we aimed to investigate the effect of an electronic monitoring device with an audiovisual reminder on adherence to inhaled corticosteroids and asthma outcomes in school-aged children who attended the emergency department with an asthma exacerbation.