Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases (RMD-mILDer)

University of Oslo (UIO)

Status

Enrolling

Conditions

Dermatomyositis

Connective Tissue Diseases

Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere

Systemic Sclerosis Pulmonary

Sjogren Syndrome with Lung Involvement

Rheumatoid Arthritis

Treatments

Diagnostic Test: A home monitoring strategy with event driven management

Study type

Interventional

Funder types

Other

Identifiers

NCT06732674

535561

Details and patient eligibility

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.

Enrollment

218 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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