[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sjogren-syndrome-with-lung-involvement\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sjogren-syndrome-with-lung-involvement":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100572392","home-based-clinical-management-of-interstitial-lung-disease-in-systemic-rheumatic-diseases-100572392",false,"NCT06732674","Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases","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","RMD-mILDer","Inclusion Criteria:\n\n* 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\n* Diagnosed interstitial lung disease (ILD) on high resolution computed tomography (HRCT) ≥ 1 year prior to randomization, not explained by other diseases or exposures\n* On stable standard of care treatment 6 months prior to randomization\n* Participants must be able to understand and follow trial procedures including completion of questionnaires regarding Patient Reported Outcome measures\n* Participants must have access to the internet, and experience in using smartphones or other electronic devices with internet access\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Severe heart failure with ejection fraction (EF) \\\u003C 30%\n* Chronic renal failure G4 or more (defined by KDIGO) with glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin using Cockroft-Gault formula.\n* End stage lung disease with forced vital capacity (FVC) \\\u003C 50% and\u002For diffusion capacity for carbon monoxide (DLCO) \\\u003C 40% or coexisting severe other lung diseases (e.g. chronic obstructive pulmonary disease, emphysema)\n* Airway obstruction (pre-bronchodilator FEV1\u002FFVC \\\u003C 0.7) (FEV1 is defined as forced expiratory volume in 1 sec)\n* In the opinion of the investigator, other clinically significant pulmonary abnormalities\n* 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 \\\u003C\u002F= 2 L\u002Fmin\u002Fm2 OR pulmonary hypertension requiring therapy with epoprostenol\u002Ftreprostinil\n* Active treatment for cancer or non-curable cancer\n* Relative contraindications to performing spirometry, as specified in ATS\u002FERS guidelines.\n* Ongoing Prednisolone ≥ 20 mg\u002Fday at inclusion\n* Unable to speak, write and read Norwegian, German or Romanian in the respective country of inclusion.\n* Unable to perform good quality measurements of FVC on the home-device comparable to results on an in-hospital device, after training.\n* Pregnancy or planned pregnancy","ALL","18 Years",{"count":20,"type":21},218,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nIt 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.",[27,28,29,30,31,32],"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",[34,35,36,37,38,39,29,40],"home monitoring","remote monitoring","interstitial lung disease","rheumatic disease","lung fibrosis","Systemic sclerosis","Sjøgren","RECRUITING","2024-12-16",{"date":44,"type":45},"2024-12-19","ACTUAL",{"date":42,"type":21},{"date":48,"type":21},"2028-02-28",{"name":50,"class":51},"Oslo University Hospital","OTHER"]