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

RecruitingNA

Sponsor: Oslo University Hospital

Conditions: Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere, Systemic Sclerosis Pulmonary, Dermatomyositis, Rheumatoid Arthritis, Sjogren Syndrome with Lung Involvement

Interventions: A home monitoring strategy with event driven management

Countries: Norway

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Oslo, Norway