Effectiveness of a Multicomponent Digital Therapeutic Program on Inhaled Medication Adherence in Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial.

Poor medication adherence is a critical impediment to effective chronic obstructive pulmonary disease (COPD) management and remains challenging to track in routine care. Digital therapeutic interventions may improve chronic disease management through remote monitoring and patient education. However, most existing digital interventions focus on individual components of disease management, and evidence from longer-term pragmatic randomized controlled trials evaluating integrated digital therapeutics in routine clinical practice remains limited.

This study aimed to evaluate the effectiveness of a multicomponent digital therapeutic program combining electronic inhaler monitoring (EIM) with behavioral support in improving medication adherence and symptom-related outcomes among patients with COPD prescribed pressurized metered-dose inhalers, and to assess patient engagement and implementation in routine clinical practice.

In this prospective, open-label, unblinded, randomized controlled trial, patients with COPD prescribed pressurized metered-dose inhalers were enrolled and randomized in a 2:1 ratio to either the intervention group or the control group. All participants received an EIM device to objectively record inhaler use throughout the 24-week study period. Patients in the intervention group also received personalized medication reminders from the EIM, adherence feedback, educational content, and clinician-supported follow-up through an integrated digital management platform based on EIM-derived data, whereas the control group received usual care. The primary outcome was medication adherence over 24 weeks. Secondary outcomes included exacerbations, COPD symptoms, quality of life, and lung function.

A total of 158 participants were randomized, including 106 in the intervention group and 52 in the control group. The median monitoring coverage was 161.5 (IQR 86.3-168.0) days during the follow-up period. The self-reported adherence measured using the Test of Adherence to Inhalers showed no significant between-group differences at any follow-up time point. However, the electronically monitored adherence was significantly higher in the intervention group than in the control group (59.5% vs 33.1%, P=.009). Adherence declined over time in both groups, decreasing from 85.3% during weeks 0 to 4 to 43.0% during weeks 12 to 24 in the intervention group and from 76.8% to 11.9% in the control group over the same intervals, resulting in a progressively larger between-group difference over follow-up. No significant differences were observed in exacerbations, health-related quality of life, symptom burden, lung function, or mental health outcomes. In an exploratory analysis, a significantly greater proportion of participants in the intervention group achieved the minimal clinically important difference in the COPD Assessment Test score than in the control group (odds ratio 2.21, 95% CI 1.11-4.41; P=.02).

The multicomponent digital therapeutic program significantly improved objective medication adherence in patients with COPD over 24 weeks. While most clinical outcomes did not differ significantly between groups, the higher proportion of participants achieving a clinically meaningful improvement in the COPD Assessment Test score warrants further investigation.