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Recruiting NCT06732674

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

No phase Interventional Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere Systemic Sclerosis Pulmonary Dermatomyositis Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A home monitoring strategy with event driven management.
Who it may be relevant to
Registry conditions: Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere, Systemic Sclerosis Pulmonary, Dermatomyositis, Rheumatoid Arthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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

Primary outcome measures

  • Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits. [Time frame: 54 weeks]
Secondary outcome measures (4)
  • Estimate effects of home monitoring compared to fixed-interval hospital visits on change in FVC [Time frame: after 54 weeks]
  • Estimate effects of home monitoring compared to fixed-interval hospital visits on FVC decline >10% events. [Time frame: baseline to week 54]
  • Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported respiratory symptoms [Time frame: baseline to week 54]
  • Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events. [Time frame: baseline to week 54]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Norway · 1 center
  • Oslo University Hospital — Oslo

Identifiers

NCT: NCT06732674 · 535561

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗