Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases
Recruiting · NCT06732674 · Interventional (participants receive a specific treatment) · Lead sponsor: Oslo University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
A home monitoring strategy with event driven management
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Oslo University Hospital - Oslo, Norway
- Oslo University Hospital - Oslo, Norway