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.
Systemic rheumatic disease (Systemic sclerosis (SSc), rheumatoid arthritis (RA), idiopathic inflammatory myopathies including antisynthetasis syndromes (IIM), mixed connective tissue disease (MCTD) or Sjøgrens disease (SjD)) classifiable by disease-specific classification criteria
Diagnosed interstitial lung disease (ILD) on high resolution computed tomography (HRCT) ≥ 1 year prior to randomization, not explained by other diseases or exposures
On stable standard of care treatment 6 months prior to randomization
Participants must be able to understand and follow trial procedures including completion of questionnaires regarding Patient Reported Outcome measures
Severe heart failure with ejection fraction (EF) < 30%
Chronic renal failure G4 or more (defined by KDIGO) with glomerular filtration rate (eGFR) < 30 mL/min using Cockroft-Gault formula.
End stage lung disease with forced vital capacity (FVC) < 50% and/or diffusion capacity for carbon monoxide (DLCO) < 40% or coexisting severe other lung diseases (e.g. chronic obstructive pulmonary disease, emphysema)
Airway obstruction (pre-bronchodilator FEV1/FVC < 0.7) (FEV1 is defined as forced expiratory volume in 1 sec)
Parallel
A home monitoring strategy with event driven management
Diagnostic testBi-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
Assess 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.
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).
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
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
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.
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported symptoms related to the rheumatic disease (RMD)
Change in visual analogue scale (VAS) on RMD from 0 - 10 with higher values indicating more symptoms
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported general well-being
Change in VAS on the patients global health from 0 - 10 with higher values indicating more symptoms
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported health related quality of life
Change in the EuroQol Eq-5D-5L questionnaire with the following domains: Mobility, self-care, usual activities, pain/discomfort, anxiety/depression. The score typically ranges from 0 (representing a health state equivalent to death) to 1 (representing perfect health).
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported disability to perform daily tasks and carry out basic activity
Change in Health Assessment Questionaire (HAQ) covering eight different domains: Dressing and grooming, arising, eating, walking, hygiene, reach, gripping and activities. The HAQ has 20 questions. The score reaches from 0 (no incapacity) to 3 (full incapacity)
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Oslo University Hospital
Lead sponsor
Carol Davila University of Medicine and Pharmacy
Collaborator
University of Zurich
Collaborator
