Home monitoring for lung disease in patients with 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
This study is testing if regular home monitoring can help people with lung disease related to rheumatic diseases manage their condition better than just going to the hospital for check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06732674 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a home-based monitoring strategy for managing interstitial lung disease associated with systemic rheumatic diseases. It is designed as a two-arm, 54-week randomized controlled trial comparing bi-weekly home monitoring with standard care that involves fixed hospital visits. Participants will undergo serial forced vital capacity measurements and report their outcomes to assess the effectiveness of this approach. The study aims to leverage eHealth technology to enhance patient management and outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults with systemic rheumatic diseases and diagnosed interstitial lung disease who have been stable on standard treatment for at least six months.
Not a fit: Patients with severe heart failure or chronic renal failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management and outcomes for patients with interstitial lung disease related to rheumatic diseases.
How similar studies have performed: Other studies have shown promise in using home monitoring for chronic diseases, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Emily V Langballe, MD
- Email: emilylangballe@hotmail.com
- Phone: 0047 2307 0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.