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

NCT06732674 | Recruiting

• 1 other identifier: 535561
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

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

Keywords

home monitoring; remote monitoring; interstitial lung disease; rheumatic disease; lung fibrosis; Systemic sclerosis; Dermatomyositis; Sjøgren

Outcome Measures

Primary Outcomes (1)

• Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits.

  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.

  54 weeks

Secondary Outcomes (4)

• Estimate effects of home monitoring compared to fixed-interval hospital visits on change in FVC

  after 54 weeks

• Estimate effects of home monitoring compared to fixed-interval hospital visits on FVC decline >10% events.

  baseline to week 54

• Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported respiratory symptoms

  baseline to week 54

• Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events.

  baseline to week 54

Other Outcomes (30)

• Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported symptoms related to the rheumatic disease (RMD)

  baseline to week 54

• Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported general well-being

  baseline to week 54

• Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported health related quality of life

  baseline to week 54

Study Arms (2)

Usual care

NO INTERVENTION

Scheduled hospital visits every 6 months

Home monitoring

EXPERIMENTAL

Home monitoring strategy with remote patient data observation twice a week

Diagnostic Test: A home monitoring strategy with event driven management

Interventions

A home monitoring strategy with event driven management DIAGNOSTIC_TEST

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

Home monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Carol Davila University of Medicine and Pharmacy: collaborator
• University of Zurich: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0873, Norway

RECRUITING

Related Links

• University homepage

MeSH Terms

Conditions

Dermatomyositis; Arthritis, Rheumatoid; Connective Tissue Diseases; Lung Diseases, Interstitial; Rheumatic Diseases; Pulmonary Fibrosis; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Arthritis; Joint Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna-Maria Hoffmann-Vold, MD, PhD

  Oslo University Hospital

  STUDY CHAIR

Central Study Contacts

Emily V Langballe, MD

CONTACT

0047 2307 0000; emilylangballe@hotmail.com

Peter M Andel, MD, Dr.med.

CONTACT

0047 2307 0000; pemian@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr med

Model Details: international, multi-center, 2-arm, 54-week, randomized controlled trial

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 13, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 28, 2028
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)