STARMAP: an observational study to assess disease-relevant outcomes using home-monitoring devices in patients with idiopathic pulmonary fibrosis (IPF)

Abstract

<b>Background:</b> The objective is to assess the use of home-based mobile health (mHealth) tools and patient-reported outcomes (PROs) to monitor IPF progression compared with in-clinic assessments collected in a 26-wk, multicenter US-only study. <b>Methods:</b> 52 patients with IPF were enrolled from 1 virtual clinic (n=13) and 4 interstitial lung disease (ILD) centers (n=39). Clinic-based forced vital capacity (FVC), 6-minute walk test, and symptom-based PROs were captured at baseline, 3 and 6 mo. Patients were provided mHealth tools to monitor daily FVC, activity, sleep and symptom-based PROs. Correlation and systematic differences between home vs. clinic-based measurements were assessed for the potential value of more frequent home-based measurements. <b>Results:</b> Baseline demographics are presented (Fig). Interim data monitored for a mean of 75 d demonstrated good compliance across mHealth tools. Baseline clinic and home-based FVC were highly correlated (r: 0.92) with a trend of systematically lower levels at home vs. clinic. <b>Conclusions:</b> Complete results of this 26-wk study summarizing adherence and outcomes from mHealth tools compared with clinic-based assessments of IPF progression at 3 and 6 mo will be reported and may provide insight into process improvements for patient-centric data collection in future clinical studies. <b>Funding:</b> Hoffmann-La Roche Ltd./Genentech, Inc.