Use of Automated Office Blood Pressure Monitoring
Primary Purpose
Hypertension, Uncontrolled Hypertension, Hypertension, White Coat
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood pressure measurement device
Sponsored by
About this trial
This is an interventional screening trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- 19 years and older
- Uncontrolled BP
- Prescribed three or more antihypertensive medications at the time of referral
- Higher risk for poor CV outcomes than patients with essential HTN
- OBPM systolic BP of greater than 140 mmHg and diastolic BP of greater than or equal to 90 mm Hg upon initial clinic assessment.
Exclusion Criteria:
- Less than 19 years old
- Had a systolic BP of less than 140 mm Hg and diastolic BP of less than 90 mmHg upon initial clinic assessment.
- Also, patients on less than three antihypertensive medications, with less than three visits, and who have controlled OBPM were excluded.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Office Blood Pressure Measurement (OBPM)
Automated Office Blood Pressure Measurement (AOBPM)
Home Blood Pressure Measurement (HBPM)
Arm Description
Traditional office blood pressure monitoring in the primary care clinical environment.
Blood pressure measurement using a validated BpTRU device
Blood pressure measurement at patient's home using home monitoring device.
Outcomes
Primary Outcome Measures
Number of participants using Traditional office blood pressure measurement (OBPM)
Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg
Number of participants using Traditional office blood pressure measurement (OBPM)
Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg
Number of participants using Traditional office blood pressure measurement (OBPM)
Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg
Number of participants using Automated office blood pressure measurement (AOBPM)
Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg
Number of participants using Automated office blood pressure measurement (AOBPM)
Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg
Number of participants using Automated office blood pressure measurement (AOBPM)
Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg
Number of participants using Home blood pressure measurement (HBPM)
Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg
Number of participants using Home blood pressure measurement (HBPM)
Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg
Number of participants using Home blood pressure measurement (HBPM)
Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg
Secondary Outcome Measures
Full Information
NCT ID
NCT05395403
First Posted
April 19, 2022
Last Updated
May 24, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
Troy University
1. Study Identification
Unique Protocol Identification Number
NCT05395403
Brief Title
Use of Automated Office Blood Pressure Monitoring
Official Title
Use of Automated Office Blood Pressure Monitoring in Older Working-age Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
July 5, 2021 (Actual)
Study Completion Date
July 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Troy University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Uncontrolled Hypertension, Hypertension, White Coat, Hypertension, Resistant to Conventional Therapy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Office Blood Pressure Measurement (OBPM)
Arm Type
Experimental
Arm Description
Traditional office blood pressure monitoring in the primary care clinical environment.
Arm Title
Automated Office Blood Pressure Measurement (AOBPM)
Arm Type
Experimental
Arm Description
Blood pressure measurement using a validated BpTRU device
Arm Title
Home Blood Pressure Measurement (HBPM)
Arm Type
Experimental
Arm Description
Blood pressure measurement at patient's home using home monitoring device.
Intervention Type
Device
Intervention Name(s)
Blood pressure measurement device
Intervention 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).
Primary Outcome Measure Information:
Title
Number of participants using Traditional office blood pressure measurement (OBPM)
Description
Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg
Time Frame
Baseline
Title
Number of participants using Traditional office blood pressure measurement (OBPM)
Description
Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg
Time Frame
Up to 8 weeks
Title
Number of participants using Traditional office blood pressure measurement (OBPM)
Description
Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg
Time Frame
Up to 16 weeks
Title
Number of participants using Automated office blood pressure measurement (AOBPM)
Description
Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg
Time Frame
Baseline
Title
Number of participants using Automated office blood pressure measurement (AOBPM)
Description
Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg
Time Frame
Up to 8 weeks
Title
Number of participants using Automated office blood pressure measurement (AOBPM)
Description
Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg
Time Frame
Up to 16 weeks
Title
Number of participants using Home blood pressure measurement (HBPM)
Description
Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg
Time Frame
Baseline
Title
Number of participants using Home blood pressure measurement (HBPM)
Description
Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg
Time Frame
Up to 8 weeks
Title
Number of participants using Home blood pressure measurement (HBPM)
Description
Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg
Time Frame
Up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
19 years and older
Uncontrolled BP
Prescribed three or more antihypertensive medications at the time of referral
Higher risk for poor CV outcomes than patients with essential HTN
OBPM systolic BP of greater than 140 mmHg and diastolic BP of greater than or equal to 90 mm Hg upon initial clinic assessment.
Exclusion Criteria:
Less than 19 years old
Had a systolic BP of less than 140 mm Hg and diastolic BP of less than 90 mmHg upon initial clinic assessment.
Also, patients on less than three antihypertensive medications, with less than three visits, and who have controlled OBPM were excluded.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
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Use of Automated Office Blood Pressure Monitoring
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