We performed a multicenter RCT in newly treated patients with IPF. Patients were randomly assigned to standard care or a home monitoring program on top of standard care for 24 weeks. The home monitoring program included home spirometry, reporting of symptoms and side-effects, PROMs, information, a medication coach and eConsultations. The primary endpoint was between-group difference in change in Kings Brief Interstitial Lung disease (K-BILD) questionnaire score at 24 weeks.
90 patients were randomized (46 patients home monitoring, 44 standard care). After 24 weeks, no statistically significant differences were found in K-BILD total score (home monitoring group:+2.7 points, standard care:+0.03, p=0.24) and psychological domain score (home monitoring group:+5.1, standard care:-0.5, p=0.1). In the home monitoring group medication was more often adjusted (1 vs 0.3 adjustments per patient, p=0.027). Patient satisfaction with the home monitoring program was high. Home-based spirometry was highly correlated with hospital-based spirometry over time.
The results of this first-ever eHealth RCT in IPF showed that a comprehensive home monitoring program did not improve overall HRQOL measured with K-BILD, but tended to improve psychological wellbeing. Home monitoring was greatly appreciated by patients and allowed for individually-tailored medication adjustments. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT03420235.