RECRUITINGINTERVENTIONAL
Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases
A 54-week, Multi-centre, 2-arm, Randomised Controlled Trial to Assess Home Monitoring for Lung Function and Patient Reported Outcome Measurements Vs. Usual Care in RheuMatic Disease-associated Interstitial Lung Disease: the RMD-mILDer Trial
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form form
Who Should NOT Join This Trial:
- 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIAGNOSTIC_TEST
A home monitoring strategy with event driven management
Bi-weekly home monitoring with forced vital capacity (FVC), patient reported outcome measures (PROMs), at-home measures of blood oxygen levels (SpO2) during 1-minute-sit-to-stand test (1MSTS) and temperature with algorithm based risk evaluation of deterioration and infection and consecutive event driven management
Locations (1)
Oslo University Hospital
Oslo, Norway