Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT05395403
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Automated Office Blood Pressure Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D059466', 'term': 'White Coat Hypertension'}, {'id': 'C563514', 'term': 'Hypertension Resistant to Conventional Therapy'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants using Traditional office blood pressure measurement (OBPM)', 'timeFrame': 'Baseline', 'description': 'Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg'}, {'measure': 'Number of participants using Traditional office blood pressure measurement (OBPM)', 'timeFrame': 'Up to 8 weeks', 'description': 'Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg'}, {'measure': 'Number of participants using Traditional office blood pressure measurement (OBPM)', 'timeFrame': 'Up to 16 weeks', 'description': 'Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg'}, {'measure': 'Number of participants using Automated office blood pressure measurement (AOBPM)', 'timeFrame': 'Baseline', 'description': 'Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg'}, {'measure': 'Number of participants using Automated office blood pressure measurement (AOBPM)', 'timeFrame': 'Up to 8 weeks', 'description': 'Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg'}, {'measure': 'Number of participants using Automated office blood pressure measurement (AOBPM)', 'timeFrame': 'Up to 16 weeks', 'description': 'Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg'}, {'measure': 'Number of participants using Home blood pressure measurement (HBPM)', 'timeFrame': 'Baseline', 'description': 'Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg'}, {'measure': 'Number of participants using Home blood pressure measurement (HBPM)', 'timeFrame': 'Up to 8 weeks', 'description': 'Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg'}, {'measure': 'Number of participants using Home blood pressure measurement (HBPM)', 'timeFrame': 'Up to 16 weeks', 'description': 'Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Uncontrolled Hypertension', 'Hypertension, White Coat', 'Hypertension, Resistant to Conventional Therapy']}, 'descriptionModule': {'briefSummary': 'Blood pressure measurements by three methods Office Blood Pressure Measurement (OBPM), Automated Office Blood Pressure Measurement (AOBPM), and Home Blood Pressure Measurement (HBPM) were collected retrospectively across three visits for patients (N=28) referred to a specialty hypertension (HTN) clinic. Demographic data were analyzed using summary statistics. The differences between AOBPM, HBPM, and OBPM were examined using mixed models repeated measures analysis for time and method for each visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years and older\n* Uncontrolled BP\n* Prescribed three or more antihypertensive medications at the time of referral\n* Higher risk for poor CV outcomes than patients with essential HTN\n* OBPM systolic BP of greater than 140 mmHg and diastolic BP of greater than or equal to 90 mm Hg upon initial clinic assessment.\n\nExclusion Criteria:\n\n* Less than 19 years old\n* Had a systolic BP of less than 140 mm Hg and diastolic BP of less than 90 mmHg upon initial clinic assessment.\n* Also, patients on less than three antihypertensive medications, with less than three visits, and who have controlled OBPM were excluded.'}, 'identificationModule': {'nctId': 'NCT05395403', 'briefTitle': 'Use of Automated Office Blood Pressure Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Use of Automated Office Blood Pressure Monitoring in Older Working-age Adults', 'orgStudyIdInfo': {'id': 'IRB-300006396'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Office Blood Pressure Measurement (OBPM)', 'description': 'Traditional office blood pressure monitoring in the primary care clinical environment.', 'interventionNames': ['Device: Blood pressure measurement device']}, {'type': 'EXPERIMENTAL', 'label': 'Automated Office Blood Pressure Measurement (AOBPM)', 'description': 'Blood pressure measurement using a validated BpTRU device', 'interventionNames': ['Device: Blood pressure measurement device']}, {'type': 'EXPERIMENTAL', 'label': 'Home Blood Pressure Measurement (HBPM)', 'description': "Blood pressure measurement at patient's home using home monitoring device.", 'interventionNames': ['Device: Blood pressure measurement device']}], 'interventions': [{'name': 'Blood pressure measurement device', 'type': 'DEVICE', 'description': 'The use of three different devices: traditional office blood pressure measurement cuff (OBPM), automated office blood pressure measurement cuff (AOBPM), and home blood pressure measurement cuff (HBPM).', 'armGroupLabels': ['Automated Office Blood Pressure Measurement (AOBPM)', 'Home Blood Pressure Measurement (HBPM)', 'Office Blood Pressure Measurement (OBPM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Troy University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Scientist and Transplant Cood', 'investigatorFullName': 'Tonya Breaux-Shropshire', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}