Home based clinical management of Interstitial Lung Disease in systemic rheumatic and musculoskeletal diseases; mILDeR-RMD
Concept
Systemic rheumatic and musculoskeletal diseases (RMDs) are complex multiorgan diseases with a high disease burden. Pulmonary involvement with interstitial lung disease (ILD) is frequent in many RMDs and is associated with reduced survival. The disease course of ILD varies, from stable to rapidly progressive disease, with a progressive period doubling mortality. Often, the disease progresses without being immediately recognized by the patients. This is often first detected at the next regular hospital visit, leading to a delay in appropriate management, and irreversible damage to the lungs. This limitation can be addressed by implementation of home monitoring with tight control of lung function and respiratory symptoms by E-health, to identify disease progression as it occurs. The major hypothesis for this project is that we will identify progressive ILD earlier in people living with RMD-ILD randomized to home monitoring compared to fixed hospital visits. Further, we hypothesize that the home monitoring approach will improve both quality of life (QoL) through more self-control by continuous monitoring, and satisfaction of people living with RMD-ILD, through closer and easier contact with health care providers.
Facts and Figures
MD, PhD Anna-Maria Hoffmann-Vold
Oslo University Hospital (OUH)
a.m.hoffmann-vold@medisin.uio.no
Meet the Team
Project Lead
MD, PhD Anna-Maria Hoffmann-VoldOslo University Hospital (OUH)
a.m.hoffmann-vold@medisin.uio.no
University Hospital Zurich
University Hospital Zurich
Cantacuzino Hospital, Carol Davila University of Medicine and Pharmacy (CH, CDUMP)
Patient Research Partner
Patient Research Partner
Objectives
The main objective is to identify disease progression earlier and to improve clinical management of people living with RMD-ILD by applying home monitoring of lung function and patient reported outcome measures (PROMs) using an E-health platform.
Goals/Milestones
To address the aims, we will conduct a multicenter international randomized clinical trial, including people living with RMD-ILD from Norway, Switzerland and Romania randomized 1:1 into a digital home monitoring or a fixed hospital visit arm with time to first progressive event (ILD progression or respiratory hospitalization) as primary endpoint. The hospital arm will be followed as standard of care management with fixed hospital visits every 6 months. The home monitoring arm will be assessed at the hospital at baseline and 52 weeks and by digital home monitoring with biweekly lung function self-assessment and respiratory symptom reporting. QoL and satisfaction will be collected through the E-health platform at 6 months intervals using standardized questionnaires. We plan to include the first participant by Q2 2024 and last participant out in Q4 2025. The main results will be available and published by Q3 2026.
Patient Voice
The main applicant has developed a user-friendly E-health platform in collaboration with Norwegian patient research partners (PRPs), which allows monitoring of lung function and QoL as well as communication between patients and health care professionals. All applicants have established a collaboration with the PRPs of this project on several other projects (eg ERS/EULAR guidelines for the management of ILD). Following the EULAR recommendations and guidance as published on the EULAR website, the PRPs will collaborate on the protocol, informed consent, tools for assessing QoL and patients’ satisfaction, participant recruitment, lay trial information and dissemination of the results.