Design, methods, and baseline characteristics of a pilot, randomized, controlled trial of the effects of an electronic monitoring device on medication adherence in children with asthma

Abstract

Non-adherence to medication is common: Current methods of assessing adherence are inaccurate. Electronic monitoring devices (EMDs) may more accurately assess adherence, but are not currently used in practice. The design, methods, and participant baseline characteristics are described for a pilot trial of the effects of an EMD on asthma medication adherence in a pediatric population.This was a pilot, randomized, controlled trial of children with persistent asthma managed with daily inhaled corticosteroids (ICS). Seventy-five children were randomized 2:1 to receive either two EMDs (one for ICS and one for rescue) linked via Bluetooth to a mobile application (app) or standard of care (controls). EMDs recorded dates and times of inhaler actuations and the app sent daily medication reminders to participants. Controls were provided standard care. Medication adherence was measured using pharmacy refill records and self-report, whereas EMD data were used to measure adherence in the intervention group. Secondary outcomes included asthma control, pulmonary function, and quality of life.

Results: One hundred sixty children were screened for eligibility, with 123 individuals excluded. Seventy-five children were enrolled, with 25 allocated to the control group and 50 to the intervention. The mean age of participants is 12 years old (±2.9), with equal proportions of male and female children; 45% are Latinx and 19% African-American; 77% report Medicaid or CHIP coverage. Half of participants have moderate persistent asthma and 48% had marginally controlled asthma at time of enrollment. There were no significant inter-group differences in baseline sociodemographic characteristics.

Conclusion: This pilot successfully reached target populations and met recruitment and enrollment goals. It is addressing an important knowledge gap by evaluating the effects of an EMD with a mobile app on adherence rates, findings which could prove useful in determining whether routine use of EMDs in clinical practice help children achieve better asthma control and outcomes.

Clinical trialsgov: NCT03734861.

Keywords: Adherence; Asthma; Children; Electronic monitoring device; Mobile health.

Fig. 1

HeroTracker EMDs attached to rescue (left) and controller (right) inhalers.

Fig. 2

Summary of participant recruitment flow, CONSORT.