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Montreal","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Mean difference in systolic BP","Mean difference in systolic BP between the home BP device and the awake ABPM","At enrollment (time 0)",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Mean difference in diastolic BP","Mean difference in diastolic BP between the home BP device and the awake ABPM",{"measure":18,"description":19,"timeFrame":12},"Mean difference in systolic BP from validated device","Mean difference in systolic BP between the non-validated home BP device and the validated home BP device",{"measure":21,"description":22,"timeFrame":12},"Mean difference in diastolic BP from validated device","Mean difference in diastolic BP between the non-validated home BP device and the validated home BP device",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","CROSSOVER","DIAGNOSTIC",{"masking":29,"maskingDescription":23,"whoMasked":30},"SINGLE",[31],"OUTCOMES_ASSESSOR",[33,39,43,47],{"label":34,"type":35,"description":36,"interventionNames":37},"Validate home BP device","ACTIVE_COMPARATOR","BP measured with a validated home BP device",[38],"Diagnostic Test: awake ABPM",{"label":40,"type":35,"description":41,"interventionNames":42},"Non-validated home BP device #1","BP measured with the first non-validated home BP device",[38],{"label":44,"type":35,"description":45,"interventionNames":46},"Non-validated home BP device #2","BP measured with the second non-validated home BP device",[38],{"label":48,"type":35,"description":49,"interventionNames":50},"Non-validated home BP device #3","BP measured with the third non-validated home BP device",[38],[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":23},"DIAGNOSTIC_TEST","awake ABPM","Comparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after",[40,44,48,34],[58],{"name":59,"role":60,"phone":61,"phoneExt":23,"email":62},"Remi Goupil, MD MSc","CONTACT","514-338-2883","remi.goupil@umontreal.ca",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Hôpital Sacré-Coeur de Montréal","RECRUITING","Montreal","Quebec","H4J 1C5","Canada","CA",{"type":73,"coordinates":74},"Point",[75,76],-73.58781,45.50884,{"lat":76,"lon":75},[79],{"name":80,"role":60,"phone":81,"phoneExt":23,"email":82},"Guylaine Marcotte","+1-514-338-2222","guylaine.marcotte.cnmtl@ssss.gouv.qc.ca",{"type":84,"investigatorFullName":59,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Principal investigator","100568989",false,"NCT06688409","Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market.","Comparing Home Blood Pressure Measurements from Devices with and Without Evidence of Validation to Ambulatory Blood Pressure Monitoring: the VALID-HomeBP Study","VALID-HomeBP","Inclusion Criteria:\n\n* Adults aged \\> 18 years scheduled to undergo an ABPM\n\nExclusion Criteria:\n\n* Upper arm size outside of cuff range of selected devices (\\\u003C22 cm or \\>42 cm)\n* Night shift workers\n* Permanent atrial fibrillation\n* Known severe aortic stenosis\n* Contraindication to measure BP on the non-dominant arm\n* Ongoing pregnancy\n* Inability or unwillingness to provide consent","ALL","18 Years",{"count":96,"type":97},140,"ESTIMATED","INTERVENTIONAL",[100],"NA","This study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake BP from ambulatory blood pressure monitoring.",[103],"Hypertension",[105,106,107,108],"hypertension","blood pressure measurement","blood pressure","blood pressure device validation","2025-02-12",{"date":111,"type":112},"2025-02-14","ACTUAL",{"date":114,"type":112},"2024-02-12",{"date":116,"type":97},"2027-11-30",{"name":5,"class":6},1]