Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases (RMD-mILDer)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Connective Tissue Diseases; Rheumatoid Arthritis; Dermatomyositis; Systemic Sclerosis Pulmonary; Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere; Sjogren Syndrome with Lung Involvement
• Intervention / Treatment: Diagnostic test: A home monitoring strategy with event driven management

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily V Langballe, MD; Phone Number: 0047 2307 0000; Email: emilylangballe@hotmail.com
• Study Contact Backup: Name: Peter M Andel, MD, Dr.med.; Phone Number: 0047 2307 0000; Email: pemian@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0873
    • Recruiting
    • Oslo University Hospital
    • Contact: Anna-Maria Hoffmann-Vold, Prof Dr; Phone Number: +4745224605; Email: anna.hoffmannvold@gmail.com
    • Contact: Emily Langballe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Scheduled hospital visits every 6 months
Experimental: Home monitoring; Home monitoring strategy with remote patient data observation twice a week	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate effects of home monitoring compared to fixed-interval hospital visits on change in FVC	Absolute change from baseline in FVC (mL) and absolute change from baseline in FVC (% predicted).	after 54 weeks
Estimate effects of home monitoring compared to fixed-interval hospital visits on FVC decline >10% events.	Proportion of patients who experience at least one FVC decline >= 10% event from baseline	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported respiratory symptoms	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	baseline to week 54
Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events.	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.	baseline to week 54

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported symptoms related to the rheumatic disease (RMD)	Change in visual analogue scale (VAS) on RMD from 0 - 10 with higher values indicating more symptoms	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported general well-being	Change in VAS on the patients global health from 0 - 10 with higher values indicating more symptoms	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported health related quality of life	Change in the EuroQol Eq-5D-5L questionnaire with the following domains: Mobility, self-care, usual activities, pain/discomfort, anxiety/depression. The score typically ranges from 0 (representing a health state equivalent to death) to 1 (representing perfect health).	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported disability to perform daily tasks and carry out basic activity	Change in Health Assessment Questionaire (HAQ) covering eight different domains: Dressing and grooming, arising, eating, walking, hygiene, reach, gripping and activities. The HAQ has 20 questions. The score reaches from 0 (no incapacity) to 3 (full incapacity)	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported pain, fatigue and dryness in included patients with interstitial lung disease (ILD) related to Sjøgrens disease (SjD-ILD)	Change in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) with a range of 0 - 10, with higher values indicating more symptoms.	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on the patient reported impact of the diseases in included patients with ILD related to systemic sclerosis	Change in EULAR Systemic Sclerosis Impact of Disease (ScleroID) questionnaire whereby higher counts on a scale from 0-100 would indicate more impact	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on Physician reported global health burden	Change in VAS on global health from 0 - 10 with higher values indicating a higher burden	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with rheumatoid arthritis associated ILD (RA-ILD)	Change in Disease Activity Score-28 (DAS28)	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with Sjøgrens disease associated ILD (SjD-ILD)	Change in EULAR Sjögren's syndrome disease activity index (ESSDAI)	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with inflammatory idiopathic myopathies including antisynthetasis syndromes on a visual analogue scales	Change in MDAAT / MYOACT (range 0-60) where higher values would indicate more disease activity	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with inflammatory idiopathic myopathies including antisynthetasis syndromes on a questionnaire based skale	Change in MDAAT / MITAX (range 0-63) where higher values would indicate more disease activity	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with systemic sclerosis	Change in Revised European Scleroderma Trials and Research Group Activity Index (EUSTAR-AI) (range 0-10) where higher values would indicate more disease activity	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on change in DLCO	Absolute change from baseline in DLCO (SI) · Absolute change from baseline in DLCO (% predicted)	at week 54
Assess effect of home monitoring compared to fixed-interval hospital visits on extent of pulmonary fibrosis on high resolution computed tomography (HRCT)	Change in extent of fibrosis as percentage of total lung parenchyma on HRCT	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on degree of patient reported disability that breathlessness poses on day-to-day activities	Change in "Modified Medical Research Council Dyspnoea Scale" (mMRC) with a range of 0-4 where higher values indicate more disability	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported dyspnea	Change on a visual analogue scale for dyspnea where higher values would indicate more symptoms	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported cough	Change on a visual analogue scale for cough where higher values would indicate more symptoms	baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported symptoms	Change on a visual analogue scale for fatigue where higher values would indicate more symptoms	baseline to week 54
Estimate ability of home monitoring compared to fixed-interval hospital visits to detect afebrile episodes	Number of verified afebrile episodes	at week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient treatment satisfaction	Difference in "Client satisfaction questionnaire 8" (CSQ-8) scores (range 8-32 where higher values indicate a higher satisfaction) between the to arms	at week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient mental health parameters	Difference on the "Hosital Anxiety and Depression Scale" (HADS) with a range of 0-21 where higher scores would indicate more depression and axiety	at week 54
Estimate the effects of home monitoring compared to fixed-interval hospital visits on identification of clinically significant Respiratory Tract Infections (csRTI)	Total number and proportion of severe csRTIs compared between the arms	at week 54
Estimate the effects of home monitoring compared to fixed-interval hospital visits on length of antibiotic treatment due to clinically significant Respiratory Tract Infections (csRTI)	Days on antibiotic therapy for csRTIs compared between the arms	at week 54
Estimate the effects of home monitoring compared to fixed-interval hospital visits on hospitalisation for clinically significant Respiratory Tract Infections (csRTI)	Days hospitalised for csRTIs compared between the arms	at week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on identification of acute exacerbations	Time to first acute exacerbation event	baseline to week 54
Assess immunologic activity in the peripheral blood by immune cells and soluble markers of inflammation in patients followed with home monitoring or fixed-interval hospital visits	Assess content and change in peripheral blood markers derived from peripheral blood (as evaluated by sequencing techniques, proteomics and cellular phenotyping)	at baseline and at week 54
Assess immunologic activity in nasal swabs by immune cells and soluble markers of inflammation in patients followed with home monitoring or fixed-interval hospital visits	Assess content and change in immune cells and soluble markers of inflammation in nasal swabs (as evaluated by sequencing techniques, proteomics and cellular phenotyping)	at baseline and at week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on changes in immunosuppressive therapy	Proportion of participants subjected to increased immunosuppression	baseline to week 54
Assess remission of non-ILD disease manifestations in patients followed with home monitoring or fixed-interval hospital visits	Proportion of participants in non-remission for non-ILD disease manifestations	at baseline and at week 54
Assess the effect of reflux disease at baseline on ILD progression	Proportion of patients who experience ILD progression with reflux disease compared to no reflux disease	after 54 weeks

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Zurich; Carol Davila University of Medicine and Pharmacy
• Investigators: Study Chair: Anna-Maria Hoffmann-Vold, MD, PhD, Oslo University Hospital

Publications and helpful links

Helpful Links

• project website
• University homepage

Study record dates

Study Major Dates

• Study Start (Estimated): December 16, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Dermatomyositis; interstitial lung disease; remote monitoring; Systemic sclerosis; home monitoring; rheumatic disease; lung fibrosis; Sjøgren
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Neuromuscular Diseases; Arthritis; Joint Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Eye Diseases; Skin Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Myositis; Polymyositis; Lung Diseases; Sclerosis; Sjogren's Syndrome; Lung Diseases, Interstitial; Scleroderma, Systemic; Scleroderma, Diffuse; Dermatomyositis; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: 535561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual patient data of this study will not be publicly available as they contain information that could compromise the privacy of research participants and may be subject to ongoing research as long as the research project is ongoing. The original data will be available from the corresponding authors of subsequent publications upon reasonable request, except where restricted by GDPR liabilities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No