Actively Recruiting
Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases
Led by Oslo University Hospital · Updated on 2024-12-19
218
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
C
Carol Davila University of Medicine and Pharmacy
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Systemic rheumatic disease (Systemic sclerosis, rheumatoid arthritis, idiopathic inflammatory myopathies including antisynthetasis syndromes, mixed connective tissue disease, or Sjogren's disease) classified by specific criteria
- Diagnosed interstitial lung disease on high resolution computed tomography at least 1 year before randomization, not caused by other diseases or exposures
- Stable standard of care treatment for 6 months prior to randomization
- Ability to understand and follow trial procedures including completing patient-reported outcome questionnaires
- Access to internet and experience using smartphones or other internet-capable electronic devices
- Signed informed consent form
You will not qualify if you...
- Severe heart failure with ejection fraction less than 30%
- Chronic renal failure stage 4 or higher with glomerular filtration rate less than 30 mL/min
- End stage lung disease with forced vital capacity under 50% and/or diffusion capacity for carbon monoxide under 40%, or severe other lung diseases
- Airway obstruction with pre-bronchodilator FEV1/FVC ratio less than 0.7
- Other clinically significant pulmonary abnormalities as judged by investigator
- Significant pulmonary hypertension with clinical or echocardiographic evidence of right heart failure or requiring specific therapy
- Active or non-curable cancer treatment
- Contraindications to spirometry per ATS/ERS guidelines
- Ongoing prednisolone treatment at 20 mg/day or higher
- Inability to speak, read, or write Norwegian, German, or Romanian depending on country
- Inability to perform good quality home FVC measurements after training
- Pregnancy or planned pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway, 0873
Actively Recruiting
Research Team
E
Emily V Langballe, MD
CONTACT
P
Peter M Andel, MD, Dr.med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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