NCT06732674招募中不适用
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
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2024年12月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits.
时间窗: 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.
次要结局
- Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events.(baseline to week 54)
- 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)
研究者
Anna-Maria Hoffmann-Vold
Prof Dr med
Oslo University Hospital
研究点 (2)
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