ClinicalTrials.gov record NCT06732674
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
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This 54-week randomized trial enrolls adults with interstitial lung disease (ILD) related to systemic rheumatic diseases. It compares a home monitoring strategy — twice-weekly home lung-function checks, symptom questionnaires, oxygen and temperature measurements with algorithm-based event management — against usual care with scheduled hospital visits. The main outcome is time to disease progression, defined by first hospital-measured FVC decline ≥5% or a non-elective respiratory hospitalization.
What it is studying. Whether regular home measurements of lung function, symptoms and oxygen levels identify disease progression earlier than fixed-interval hospital monitoring in rheumatic-disease associated ILD.
What the researchers hope to learn. To determine if home monitoring detects ILD progression earlier than fixed hospital visits; to estimate effects on FVC change, rates of large FVC declines (≥10%), patient-reported respiratory symptoms, and occurrence of progressive pulmonary fibrosis events over 54 weeks.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Diagnostic test
- A home monitoring strategy with event driven management
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are followed for 54 weeks and are randomized to either usual care (scheduled hospital visits every 6 months) or a home-monitoring strategy. Home monitoring includes twice-weekly home FVC (forced vital capacity) measurements, patient-reported outcome questionnaires, at-home pulse oximetry (SpO2) during a 1-minute sit-to-stand test and temperature checks; data are evaluated by an algorithm that can trigger event-driven management. All participants will receive training to use the home device and must be able to perform reliable home FVC measurements; hospital FVC tests and clinic assessments will also be used.
How the study is structured. A 54-week, open-label, randomized trial with two parallel groups. One group uses twice-weekly home monitoring (FVC, patient-reported outcome measures, SpO2 during a 1-minute sit-to-stand test, and temperature) with algorithm-based risk evaluation and event-driven management. The other group receives usual care with scheduled hospital visits (every 6 months). There is no masking.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Norway. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on polymyositis
This trial is also listed on this site under dermatomyositis.
Important dates
- Study start
- Dec 16, 2024 (estimated)
- Primary completion
- Oct 1, 2026 (estimated)
- Study completion
- Feb 28, 2028 (estimated)
- Target enrollment
- 218 participants (estimated)
- Last updated on registry
- Dec 19, 2024
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Oslo University Hospital
- Principal investigator
- Anna-Maria Hoffmann-Vold, Prof Dr med
Oslo University Hospital - Collaborators
- Carol Davila University of Medicine and Pharmacy
- University of Zurich
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Emily V Langballe, MD 📞 0047 2307 0000 ✉ emilylangballe@hotmail.com
- Peter M Andel, MD, Dr.med. 📞 0047 2307 0000 ✉ pemian@ous-hf.no
Participating sites (1)
- Oslo University HospitalRecruiting
Oslo, 0873 · Norway
- Anna-Maria Hoffmann-Vold, Prof Dr · +4745224605 · anna.hoffmannvold@gmail.com
- Emily Langballe
Terms used on this page · explanations by MedicalUpdates.ai
- randomised
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- forced vital capacity
- A breathing test that measures the total amount of air a person can blow out after a full breath in. It is often given as a percentage of what is expected for a person's age and size.
- standard of care
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- computed tomography
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- Outcome measures
- Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- glomerular filtration rate
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- DLCO
- A breathing test that measures how well the lungs pass oxygen from the air into the blood.
- contraindications
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- Prednisolone
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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