Clinical trial NCT06732674: Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Carol Davila University of Medicine and Pharmacy
name: University of Zurich
First posted: 2024-12-13
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: international, multi-center, 2-arm, 54-week, randomized controlled trial
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits.
timeFrame: 54 weeks
Secondary outcomes:
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on change in FVC
timeFrame: after 54 weeks
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on FVC decline >10% events.
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported respiratory symptoms
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events.
timeFrame: baseline to week 54
Other outcomes:
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported symptoms related to the rheumatic disease (RMD)
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported general well-being
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported health related quality of life
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported disability to perform daily tasks and carry out basic activity
timeFrame: baseline to week 54
measure: 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)
timeFrame: baseline to week 54
measure: 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
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on Physician reported global health burden
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with rheumatoid arthritis associated ILD (RA-ILD)
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with Sjøgrens disease associated ILD (SjD-ILD)
timeFrame: baseline to week 54
measure: 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
timeFrame: baseline to week 54
measure: 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
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with systemic sclerosis
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on change in DLCO
timeFrame: at week 54
measure: Assess effect of home monitoring compared to fixed-interval hospital visits on extent of pulmonary fibrosis on high resolution computed tomography (HRCT)
timeFrame: baseline to week 54
measure: 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
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported dyspnea
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported cough
timeFrame: baseline to week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported symptoms
timeFrame: baseline to week 54
measure: Estimate ability of home monitoring compared to fixed-interval hospital visits to detect afebrile episodes
timeFrame: at week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on patient treatment satisfaction
timeFrame: at week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on patient mental health parameters
timeFrame: at week 54
measure: Estimate the effects of home monitoring compared to fixed-interval hospital visits on identification of clinically significant Respiratory Tract Infections (csRTI)
timeFrame: at week 54
measure: 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)
timeFrame: at week 54
measure: Estimate the effects of home monitoring compared to fixed-interval hospital visits on hospitalisation for clinically significant Respiratory Tract Infections (csRTI)
timeFrame: at week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on identification of acute exacerbations
timeFrame: baseline to week 54
measure: 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
timeFrame: at baseline and at week 54
measure: 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
timeFrame: at baseline and at week 54
measure: Estimate effects of home monitoring compared to fixed-interval hospital visits on changes in immunosuppressive therapy
timeFrame: baseline to week 54
measure: Assess remission of non-ILD disease manifestations in patients followed with home monitoring or fixed-interval hospital visits
timeFrame: at baseline and at week 54
measure: Assess the effect of reflux disease at baseline on ILD progression
timeFrame: after 54 weeks
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Anna-Maria Hoffmann-Vold, MD, PhD
role: STUDY_CHAIR
References: