[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100316177":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":50,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":50,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":50,"enrollmentInfo":74,"targetDuration":50,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":48,"whyStopped":50,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Laval University","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Control","The intervention is an hospitalization with usual care. The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria",[12],"Other: Control",{"label":14,"type":15,"description":16,"interventionNames":17},"FreeDom","ACTIVE_COMPARATOR","FreeDom strategy (early discharge, automated weaning at home, telemedicine, telereadaptation):\n\n-initial conventional hospitalization before discharge home, O2 flow rate automatically titrated by FreeO2 (based on a SpO2 target). The hospital discharge will be possible if the definite criteria are met.\n\nAfter hospital discharge, patient will have home hospitalisation. Automated oxygen flow titration, patient education will be conducted for using the telemedicine system, for questionnaires and for the tele-rehabilitation program will be initiated for home hospitalization,",[18],"Device: FreeDom",[20,25],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria",[9],[24],"Usual oxygen administration and usual hospitalization",{"type":26,"name":14,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation",[14],[30],"Early Hospital discharge with home hospitalisation",[32],{"name":33,"affiliation":5,"role":34},"François Lellouche","PRINCIPAL_INVESTIGATOR",[36,41],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","418-656-8711","3572","francois.lellouche@criucpq.ulaval.ca",{"name":42,"role":37,"phone":38,"phoneExt":43,"email":44},"Pierre-alexandre Bouchard","2712","pierre-alexandre.bouchard@criucpq.ulaval.ca",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Institut Universitaire de Cardiologie et de Pneumologie de Québec","RECRUITING","Québec",null,"G1V4G5","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-71.21454,46.81228,{"lat":58,"lon":57},[61],{"name":62,"role":37,"phone":50,"phoneExt":50,"email":40},"Francois Lellouche",{"type":34,"investigatorFullName":33,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Principal Investigator","100316177","freedom-innovative-strategy-for-the-management-of-copd-exacerbations-100316177",false,"NCT03396172","FreeDom: Innovative Strategy for the Management of COPD Exacerbations","FreeDom : Innovative Strategy for the Management of COPD Exacerbations Combining Early Hospitalisation Discharge, Automated Oxygen Weaning at Home, Telemedicine and Tele-rehabilitation","Inclusion Criteria:\n\nAll patients hospitalized for COPD exacerbation for less than 48 hours will be considered.\n\n* known or suspected COPD to entry\n* Age \\> or = 40 years\n* Ex-smoker history (10 pack \u002F year or more)\n* Acute Exacerbation: dyspnea of recent onset (less than 15 days)\n* The need for oxygen therapy with a moderate rate: \\\u003C6L \u002F min to maintain SpO2 \\> 90% (for oxygen dependent patient, the oxygen flow must be higher than flow at home)\n\nExclusion Criteria:\n\n* Refusal to consent to participate in the study,\n* Indication for an imminent intubation according to the pulmonologist,\n* Sleep Apnea\n* NIV used at home\n* Lack of FreeO2 system available at the time of randomization\n* Non-autonomous and alone at home\n* Patient alone at home\n* Patients who live more than 50 km from the hospital\n* Patient already included in the study within 3 months","ALL","18 Years",{"count":75,"type":76},100,"ESTIMATED","INTERVENTIONAL",[79],"NA","The main objective of the study is to assess the \"FreeDom\" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation.\n\nThe main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.",[82,83],"Oxygen Deficiency","COPD Exacerbation",[85,86,87,88,89,90],"COPD","Homecare","Oxygen","Telemedicine","Automated oxygen adjustment","Rehabilitation program","2024-06-17",{"date":93,"type":94},"2024-06-18","ACTUAL",{"date":96,"type":94},"2018-05-24",{"date":98,"type":76},"2025-12",{"name":5,"class":6},1]