Home Lung Monitoring for People with Rheumatic Disease-Related Lung Disease
Tests home lung checks against hospital visits in adults with rheumatic lung disease.
Plain-language title generated from the registry record
Registry title: Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases
Key facts
- Where
- Oslo, NorwaySee the site
Where in Norway
- Oslo University HospitalOslo, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital
- Trial code
- NCT06732674
- Record updated
- 19 December 2024
- Original description
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.Read full original descriptionShow less
A 54-week, Multi-centre, 2-arm, Randomised Controlled Trial to Assess Home Monitoring for Lung Function and Patient Reported Outcome Measurements Vs. Usual Care in RheuMatic Disease-associated Interstitial Lung Disease: the RMD-mILDer Trial
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.
Inclusion: 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; Participants must have access to the internet, and experience in using smartphones or other electronic devices with internet access; Signed informed consent form.
Exclusion: Significant pulmonary hypertension defined by the following: Previous clinical or echocardiographic evidence of significant right heart failure OR history of right heart catheterization showing a cardiac index </= 2 L/min/m2 OR pulmonary hypertension requiring therapy with epoprostenol/treprostinil; 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); Active treatment for cancer or non-curable cancer; 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; Airway obstruction (pre-bronchodilator FEV1/FVC < 0.7) (FEV1 is defined as forced expiratory volume in 1 sec); In the opinion of the investigator, other clinically significant pulmonary abnormalities; Relative contraindications to performing spirometry, as specified in ATS/ERS guidelines; Ongoing Prednisolone ≥ 20 mg/day at inclusion; Unable to speak, write and read Norwegian, German or Romanian in the respective country of inclusion; Unable to perform good quality measurements of FVC on the home-device comparable to results on an in-hospital device, after training; Pregnancy or planned pregnancy.