Use of Automated Office Blood Pressure Monitoring

Use of Automated Office Blood Pressure Monitoring in Older Working-age Adults

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Hypertension, Resistant to Conventional Therapy; Uncontrolled Hypertension; Hypertension, White Coat
• Intervention / Treatment: Device: Blood pressure measurement device

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Office Blood Pressure Measurement (OBPM); Traditional office blood pressure monitoring in the primary care clinical environment.	Device: Blood pressure measurement device; 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).
EXPERIMENTAL: Automated Office Blood Pressure Measurement (AOBPM); Blood pressure measurement using a validated BpTRU device	Device: Blood pressure measurement device; 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).
EXPERIMENTAL: Home Blood Pressure Measurement (HBPM); Blood pressure measurement at patient's home using home monitoring device.	Device: Blood pressure measurement device; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants using Traditional office blood pressure measurement (OBPM)	Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg	Baseline
Number of participants using Traditional office blood pressure measurement (OBPM)	Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg	Up to 8 weeks
Number of participants using Traditional office blood pressure measurement (OBPM)	Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg	Up to 16 weeks
Number of participants using Automated office blood pressure measurement (AOBPM)	Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg	Baseline
Number of participants using Automated office blood pressure measurement (AOBPM)	Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg	Up to 8 weeks
Number of participants using Automated office blood pressure measurement (AOBPM)	Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg	Up to 16 weeks
Number of participants using Home blood pressure measurement (HBPM)	Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg	Baseline
Number of participants using Home blood pressure measurement (HBPM)	Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg	Up to 8 weeks
Number of participants using Home blood pressure measurement (HBPM)	Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg	Up to 16 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Troy University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2021
• Primary Completion (ACTUAL): July 5, 2021
• Study Completion (ACTUAL): July 5, 2021

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (ACTUAL): May 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; White Coat Hypertension
• Other Study ID Numbers: IRB-300006396

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No