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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits. [Срок оценки: 54 weeks]

Вторичные конечные точки (4)

• Estimate effects of home monitoring compared to fixed-interval hospital visits on change in FVC [Срок оценки: after 54 weeks]
• Estimate effects of home monitoring compared to fixed-interval hospital visits on FVC decline >10% events. [Срок оценки: baseline to week 54]
• Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported respiratory symptoms [Срок оценки: baseline to week 54]
• Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events. [Срок оценки: baseline to week 54]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Норвегия · 1 центр

• Oslo University Hospital — Oslo

Идентификаторы

NCT: NCT06732674 · 535561

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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