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

Not Applicable

Recruiting

• 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

• Registration Number: NCT06732674
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-13
• Study Start: 2024-12-16
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-10-01
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 218

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits.	54 weeks	Time from baseline to disease progression assessed as first forced vital capacity (FVC) ≥5% decline (assessed by hospital FVC measurements) or non-elective hospitalization due to respiratory cause.

Secondary Outcome Measures

Name	Time	Method
Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events.	baseline to week 54	Proportion of patients who experience a progressive pulmonary fibrosis event defined as fibrosing ILD fulfilling ≥2 (out of 3) criteria (worsening respiratory symptoms, radiological progression, and physiological progression (absolute decline in FVC ≥ 5% predicted within 1 year follow up OR absolute decline in diffusion capacity for carbon monoxide (DLCO) ≥10% predicted within 1 year of follow up) occurring within the past year with no alternative explanation in a patient with ILD.
Estimate effects of home monitoring compared to fixed-interval hospital visits on change in FVC	after 54 weeks	Absolute change from baseline in FVC (mL) and absolute change from baseline in FVC (% predicted).
Estimate effects of home monitoring compared to fixed-interval hospital visits on FVC decline >10% events.	baseline to week 54	Proportion of patients who experience at least one FVC decline \>= 10% event from baseline
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported respiratory symptoms	baseline to week 54	Change in "Living with pulmonary fibrosis score" (LPF) total score, as well as the subdomains physical health, emotional well-being, social impact, functionality and daily activities as well as cognitive function where lower values indicate quality of life

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway