JMIR Publications

ABSTRACT

Background:

Poor medication adherence is a critical impediment to effective COPD management and remains challenging to track in routine care. Digital therapeutic interventions may improve chronic disease management through behavioral support, remote monitoring, and patient education.

Objective:

We developed a multi-component digital therapeutic program combining electronic inhaler monitoring with behavioral support and evaluated its effect on adherence and clinical outcomes in COPD patients.

Methods:

In this prospective, open-label randomized controlled trial, 158 COPD patients using pressurized metered-dose inhalers were randomized 2:1 and provided with electronic monitoring devices. Patients in the intervention group (n=106) received medication reminders, adherence feedback, and educational content through the device and a mobile application. Adherence and clinical outcomes were assessed over 24 weeks.

Results:

Mean electronically monitored adherence was significantly higher in the intervention group than in controls (59.5% vs. 33.1%, p<0.01). The intervention group experienced numerically fewer moderate-to-severe exacerbations (32% reduction) and severe exacerbations (46% reduction), though these differences did not reach statistical significance. At 24 weeks, the between-group difference in SGRQ-C total score was 3.10 points (p=0.080), approaching the minimal clinically important difference. No significant differences were observed in CAT score, lung function, or mental health outcomes.

Conclusions:

The multi-component digital therapeutic program markedly improved objective medication adherence in COPD patients over 24 weeks. Its effect on key clinical outcomes, including exacerbations and health status, remains suggestive but not conclusive, highlighting the need for larger trials and implementation research. Clinical Trial: ClinicalTrials.gov (identifier: NCT05667363). Registered on December 19, 2022.