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Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases

NCT06732674 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2024-12-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Carol Davila University of Medicine and Pharmacy

    collaborator OTHER

  • University of Zurich

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Anna-Maria Hoffmann-Vold, MD, PhD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2026-10-01
Completion
2028-02-28

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06732674 on ClinicalTrials.gov