Design of a randomized controlled trial comparing hybrid care with standard care for people with pulmonary fibrosis

BACKGROUND: People with pulmonary fibrosis (PF) live with persistent dyspnea, chronic cough, and fatigue. Symptoms that impair their exercise capacity and quality of life. The need for frequent outpatient clinic visits to evaluate disease progression and treatment response can impose a substantial burden on people with PF. Online home monitoring has the potential to replace some of these visits. However, structural implementation and evidence on its impact on patient outcomes are lacking. Here, we describe the design of the SUITS study, a multicenter randomized controlled trial (RCT) which aims to evaluate the impact of partly replacing conventional outpatient clinic visits with home monitoring and video consultations on clinically relevant patient outcomes and efficiency of healthcare systems. METHODS: Patients will be randomized to either standard care (3-monthly outpatient clinic visits) or hybrid care. Hybrid care consists of a home monitoring program and video consultations that alternately replace outpatient clinic visits. In an online application, patients perform weekly home spirometry and pulse-oximetry measurements, fill out patient reported outcome measures (PROMs) on a regular basis, and have access to an information library with disease specific information. The primary endpoint of this RCT is the change in patient self-management from baseline to 12 months, assessed with the validated patient activation measure (PAM). DISCUSSION: In light of the insufficient implementation of a hybrid care pathway for people with PF, there is pressing need for a trial to confirm if partly replacing outpatient clinic visits with home monitoring and video consultations is both feasible and effective. REGISTRATION DETAILS: Clinicaltrials.Gov: NCT06883448, date of registration: 13-03-2025. The study was retrospectively registered. No changes were made to the IRB approved study protocol (version 1, 11-01-2024) prior to registration at ClinicalTrials.gov.