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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere
• Systemic Sclerosis Pulmonary
• Dermatomyositis
• Rheumatoid Arthritis
• Sjogren Syndrome with Lung Involvement
• Connective Tissue Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-16
• Primary completion: 2026-10-01
• Completion: 2028-02-28
• First posted: 2024-12-13
• Last updated: 2024-12-19

Locations

1 site across 1 country: Norway