The RMD-mILDer trial is a home monitoring strategy trial aiming to improve management of interstitial lung disease related to rheumatic diseases applying eHealth technology. It is planned as a 2 arm 54 week multi-centre randomised controlled trial to assess outcome of home monitoring with bi-weekly serial forced vital capacity- and patient reported outcome-measurements compared to standard of care with fixed-interval hospital visits in adult patients with rheumatic disease associated interstitial lung diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
218
Bi-weekly home monitoring with forced vital capacity (FVC), patient reported outcome measures (PROMs), at-home measures of blood oxygen levels (SpO2) during 1-minute-sit-to-stand test (1MSTS) and temperature with algorithm based risk evaluation of deterioration and infection and consecutive event driven management
Oslo University Hospital
Oslo, Norway
RECRUITINGAssess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits.
Time from baseline to disease progression assessed as first forced vital capacity (FVC) ≥5% decline (assessed by hospital FVC measurements) or non-elective hospitalization due to respiratory cause.
Time frame: 54 weeks
Estimate effects of home monitoring compared to fixed-interval hospital visits on change in FVC
Absolute change from baseline in FVC (mL) and absolute change from baseline in FVC (% predicted).
Time frame: after 54 weeks
Estimate effects of home monitoring compared to fixed-interval hospital visits on FVC decline >10% events.
Proportion of patients who experience at least one FVC decline \>= 10% event from baseline
Time frame: baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported respiratory symptoms
Change in "Living with pulmonary fibrosis score" (LPF) total score, as well as the subdomains physical health, emotional well-being, social impact, functionality and daily activities as well as cognitive function where lower values indicate quality of life
Time frame: baseline to week 54
Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events.
Proportion of patients who experience a progressive pulmonary fibrosis event defined as fibrosing ILD fulfilling ≥2 (out of 3) criteria (worsening respiratory symptoms, radiological progression, and physiological progression (absolute decline in FVC ≥ 5% predicted within 1 year follow up OR absolute decline in diffusion capacity for carbon monoxide (DLCO) ≥10% predicted within 1 year of follow up) occurring within the past year with no alternative explanation in a patient with ILD.
Time frame: baseline to week 54
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