Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases
Recruiting now · Not applicable
Conditions studied: Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere, Systemic Sclerosis Pulmonary, Dermatomyositis, Rheumatoid Arthritis, Sjogren Syndrome with Lung Involvement, Connective Tissue Diseases
In brief
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.
Key facts
- Study ID
- NCT06732674
- Run by
- Oslo University Hospital
- People needed
- 218
- Starts
- 2024-12-16
- Expected to finish
- 2028-02-28
- Last updated by the study team
- 2024-12-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Oslo University Hospital — Oslo, Norway (enrolling)
Full record on ClinicalTrials.gov
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