[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572392":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":57,"collaborators":61,"id":66,"slug":12,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":12,"enrollmentInfo":75,"targetDuration":12,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care","NO_INTERVENTION","Scheduled hospital visits every 6 months",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Home monitoring","EXPERIMENTAL","Home monitoring strategy with remote patient data observation twice a week",[18],"Diagnostic Test: A home monitoring strategy with event driven management",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"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",[14],[26],{"name":27,"affiliation":5,"role":28},"Anna-Maria Hoffmann-Vold, MD, PhD","STUDY_CHAIR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Emily V Langballe, MD","CONTACT","0047 2307 0000","emilylangballe@hotmail.com",{"name":36,"role":32,"phone":33,"phoneExt":12,"email":37},"Peter M Andel, MD, Dr.med.","pemian@ous-hf.no",[39],{"facility":5,"status":40,"city":41,"state":12,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Oslo","0873","Norway",{"type":45,"coordinates":46},"Point",[47,48],10.74609,59.91273,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":12,"email":54},"Anna-Maria Hoffmann-Vold, Prof Dr","+4745224605","anna.hoffmannvold@gmail.com",{"name":56,"role":32,"phone":12,"phoneExt":12,"email":12},"Emily Langballe",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Anna-Maria Hoffmann-Vold","Prof Dr med",[62,64],{"name":63,"class":6},"Carol Davila University of Medicine and Pharmacy",{"name":65,"class":6},"University of Zurich","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":76,"type":77},218,"ESTIMATED","INTERVENTIONAL",[80],"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.",[83,84,85,86,87,88],"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",[90,91,92,93,94,95,85,96],"home monitoring","remote monitoring","interstitial lung disease","rheumatic disease","lung fibrosis","Systemic sclerosis","Sjøgren","2024-12-16",{"date":99,"type":100},"2024-12-19","ACTUAL",{"date":97,"type":77},{"date":103,"type":77},"2028-02-28",{"name":5,"class":6},1]