RecruitingNot ApplicableNCT06732674

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


Sponsor

Oslo University Hospital

Enrollment

218 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a home-based monitoring and management program for people who have lung scarring (interstitial lung disease, or ILD) caused by a rheumatic disease such as rheumatoid arthritis, scleroderma, or myositis. The goal is to see whether managing ILD from home is as good as or better than standard clinic-based care. **You may be eligible if...** - You have a systemic rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis, inflammatory myopathies, mixed connective tissue disease, or Sjögren's disease) - You have been diagnosed with ILD on a CT scan for at least 1 year - You have been on stable treatment for the past 6 months - You have internet access and can use a smartphone or tablet - You are able to understand and complete questionnaires **You may NOT be eligible if...** - Your ILD diagnosis is less than 1 year old - Your treatment has changed in the past 6 months - You cannot use digital devices or access the internet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTA 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

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NCT06732674


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