Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases

Launched by OSLO UNIVERSITY HOSPITAL · Dec 12, 2024

Keywords

ClinConnect Summary

The RMD-mILDer trial is a study designed to improve how we manage lung disease that affects patients with certain rheumatic diseases, like systemic sclerosis, rheumatoid arthritis, and Sjögren's syndrome. This trial will compare two approaches: one group will use a home monitoring system that includes regular check-ins and tests via the internet, while the other group will continue with traditional hospital visits. The goal is to see if home monitoring can help patients manage their lung health more effectively over a period of 54 weeks.

To participate in this trial, individuals need to have a confirmed diagnosis of a systemic rheumatic disease and interstitial lung disease that has been stable for at least a year. They should also be using standard treatment and must have access to the internet and be comfortable using electronic devices. Participants will be asked to complete questionnaires about their health and will receive training on how to measure their lung function at home. It's important to note that certain health conditions, like severe heart or lung diseases, may exclude someone from joining the trial. Overall, this study aims to explore new ways to help patients better manage their symptoms and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)
• • In the opinion of the investigator, other clinically significant pulmonary abnormalities
• • 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
• • Active treatment for cancer or non-curable cancer
• • 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