Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT02217059
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2014-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emergency Department Home Blood Pressure Monitoring and BpTRU Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2014-08-07', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of emergency department attendings that accurately predict which patients meet criteria for hypertension in two week follow-up using home blood pressure monitoring.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'The predictive value of the emergency department measured blood pressure by the standard ED blood pressure device, BpTRU device, and home blood pressure device for hypertension in follow-up', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Emergency Medical Services', 'Emergency Care', 'Hypertension', 'BpTRU', 'Blood pressure'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.", 'detailedDescription': "Evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring \\& evaluate reliability of ED measured elevated blood pressure compared to the BpTRU"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Emergency Department', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One elevated blood pressure greater than 120 systolic and/or 80 diastolic\n* BpTRU device blood pressure greater than 120 systolic and/or 80 diastolic while in ED\n\nExclusion Criteria:\n\n* Prior history of hypertension\n* Currently on antihypertensives or receiving prescription on discharge\n* Pregnancy\n* History of atrial fibrillation\n* Dialysis patient\n* Nursing home or rehabilitation center resident\n* Admitted\n* Moving out of the area in next 30 days\n* Substance abuse\n* Prisoner\n* Presenting for psychiatric complaint requiring constant observation\n* Inability to give informed consent (intoxicated, altered, non-English speaking)\n* Presenting with symptoms of hypertensive emergency\n* Inability to demonstrate adequate use of the home blood pressure device in the ED\n* Arm circumference less than 9 inches or greater than 17 inches'}, 'identificationModule': {'nctId': 'NCT02217059', 'briefTitle': 'Emergency Department Home Blood Pressure Monitoring and BpTRU Study', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': "Congruence of Emergency Department Attendings' Predictions of Hypertension With Results of Home Blood Pressure Monitoring", 'orgStudyIdInfo': {'id': 'UEMF0000'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prehypertension', 'description': 'Using the JNC7 definition'}, {'label': 'Stage I Hypertension', 'description': 'Using the JNC7 definition'}, {'label': 'Stage II Hypertension', 'description': 'Using the JNC7 definition'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}