Effect of telemonitoring on adherence to inhalation therapy and pulmonary exacerbations in people with cystic fibrosis (conneCT CF): a multicenter randomized controlled trial
Stephanie Thee, Mirjam Stahl, Sivagurunathan Sutharsan, Rainald Fischer, Manfred Ballmann, Svenja Straßburg, Felicitas Lauer, Julia Weitzel, Ann-Kathrin Ketter, Daniel Lorenz, Juliane Schiller, Franziska Püschner, Volker Eric Amelung, Carola Fuchs, Marcus A MallAbstract
Rationale
Recurrent pulmonary exacerbations contribute substantially to lung function decline in people with cystic fibrosis (CF). Inhalation therapies are a cornerstone of standard of care, yet adherence to inhalation therapies is variable and data on the relationship between adherence and pulmonary exacerbations remain limited.
Objectives
To assess the impact of multimodal telemonitoring and coaching on adherence and pulmonary exacerbations in people with CF.
Methods
In this prospective, multicenter, unblinded, randomized, controlled trial people with CF aged ≥12 years were randomized (1:1) to either standard of care or an intervention involving continuous objective home monitoring of inhalation adherence, weekly home spirometry, a self-management app, professional telephone coaching, and optional video conferencing over 18 months. The primary endpoint was time to first pulmonary exacerbation.
Measurements and Main results
296 participants were included with a mean age of 31.3 (SD 10.8) years, 54.1% females, mean FEV1% predicted of 70.2% (SD 24.7), 52.7% chronically infected with Pseudomonas aeruginosa, and 85.1% on triple CFTR modulator therapy. Baseline adherence was higher in the intervention group (58.1%) than in the control group (44.0%) and remained higher throughout the study (last 6 months: 49.2% vs. 32.6%). Time to first exacerbation did not differ between groups. However, across all participants, a 10% increase in adherence correlated with a 9% reduction in pulmonary exacerbation risk. Participants with FEV1<40% had a 2.4-fold higher risk of exacerbations.
Conclusion
Multimodal telemedicine improved inhalation therapy adherence. The association between higher adherence and reduced exacerbations highlights the ongoing importance of inhalation therapy in CF, even with widespread CFTR modulator use.
Clinical trial registered with German Clinical Trials Register (DRKS00024642)