A randomised controlled trial to improve medication adherence in COPD patients using a Digital Therapeutics Program

<bold>Background:</bold> Non-adherence in patients with COPD are proved to be a primary barrier to optimal disease control which can hardly be recorded and intervened. The bringing of “digital therapeutics (DTx)” may provide a vital method to turn of the tables. This study was designed to assess if using electronic inhaler monitoring device and online management platform can improve COPD patients’ inhaled medication adherence. <bold>Methods:</bold> This prospective, open-label, randomized study recruited COPD patients prescribed with metered dose inhalers medication and distributed an electronic inhaler monitoring (EIM) device to each participant to record the inhaler use. Mobile app with the function of generating adherence reports, setting personalized reminders, providing patient education information and receiving prodding from clinicians based on data the EIM collected was allocated to the active group. All the participants received follow-up at weeks 4, 12 and 24. The primary outcome was the medication adherence during the 24 weeks between groups. <bold>Results:</bold> Of 157 recruited patients, 86 has completed the follow-up up to 28 January 2024. Current results indicate a significant difference in medication adherence between active group and control group during the 24 week period (61.71% vs. 47.59%, p = 0.010). The difference between the two groups are more obvious over enrollment time (73.78% vs. 67.37% during week 0-4, 63.73% vs. 47.06% during week 4-12, 52.50% vs. 37.34% duringt week 12-24). <bold>Conclusions:</bold> The digital therapeutics program can slow down the reduction of medication adherence in COPD patients and the effect becomes more obvious with longer using duration.