[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583267":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":64,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":92,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Barron Associates, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ROAM Group","EXPERIMENTAL","The ROAM group participants will have access to the ROAM user feedback display on their concentrator and portable tank oxygen delivery systems, throughout the 4-week study duration.",[13],"Device: Activated ROAM System with User Feedback",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","SHAM_COMPARATOR","The control group participants will have their oxygen delivery concentrators and portable tanks fitted with the ROAM system, which will monitor their usage, but they will not receive any of the user feedback or have access to the ROAM software.",[19],"Device: Sham Comparator",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Activated ROAM System with User Feedback","The activated ROAM device will provide the user with daily information about their oxygen therapy usage and pulse oximetry.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Comparator","The sham comparator is a ROAM device that monitors oxygen usage, but keeps the usage details blind to the user.",[15],[32],{"name":33,"affiliation":34,"role":35},"Eileen Krepkovich, MS","Barron Associates","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","434-973-1215","123","krepkovich@barron-associates.com",[43],{"facility":44,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University of Virginia","Charlottesville","Virginia","22903","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-78.47668,38.02931,{"lat":54,"lon":53},[57,61],{"name":58,"role":38,"phone":59,"phoneExt":26,"email":60},"Yun Shim, MD","434-924-5219","YSS6N@uvahealth.org",{"name":58,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[65,67],{"name":44,"class":66},"OTHER",{"name":68,"class":69},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100583267","respiratory-oxygen-adherence-monitor-for-chronic-obstructive-pulmonary-disease-patients-100583267",false,"NCT06874101","Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients","Evaluating a Respiratory Oxygen Adherence Monitor for COPD Patients With Long-term Oxygen Therapy","ROAM","Inclusion Criteria:\n\n* Post-Bronchodilator FEV1\u002FFVC\\\u003C.80\n* Participants with medical history of COPD\n* Prescription for oxygen use via nasal cannula or mask at home\n* At baseline of health with no hospitalization\u002Fexacerbation within the past 6 weeks\n* Use of Continuous oxygen at baseline\n\nExclusion Criteria:\n\n* Post -Bronchodilator FEV1\u002FFVC ≤25%\n* Intermittent oxygen use at home\n* Inability to understand simple instructions\n* Respiratory exacerbation or infections within 6 weeks prior to screen visit\n* Not at baseline of medical health prior to screen visit","ALL","21 Years",{"count":81,"type":82},100,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to test a device called \"ROAM\" that is being developed to see how patients with chronic obstructive pulmonary disease (COPD) use oxygen therapy over a long period of time. This study will focus on evaluating the ROAM device, which will be attached to your oxygen source. The question that the study aims to answer is: will patients who receive daily adherence feedback from the ROAM have increased adherence to their prescribed long term oxygen therapy regimens?\n\nResearchers will compare the amount of time using oxygen and attitudes about oxygen therapy observed in a group that receives feedback from ROAM, and a control group that does not receive feedback.\n\nParticipants will have their oxygen supplies fitted with the ROAM device and then use their oxygen as usual for the 5-week study duration. Participants in the study group will have access to information about their oxygen usage and pulse oximetry levels. All participants will attend two in-clinic sessions of about an hour each, and will complete questionnaires at the beginning and end of the study.",[88,89],"COPD","COPD - Chronic Obstructive Pulmonary Disease",[91,88],"oxygen therapy","NOT_YET_RECRUITING","2025-03-07",{"date":95,"type":96},"2025-03-13","ACTUAL",{"date":98,"type":82},"2025-05-01",{"date":100,"type":82},"2026-04-30",{"name":5,"class":6},1]