Use of Automated Office Blood Pressure Monitoring

NCT05395403 | Completed

• 1 other identifier: IRB-300006396
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Uncontrolled Hypertension; Hypertension, White Coat; Hypertension, Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (3)

Office Blood Pressure Measurement (OBPM)

EXPERIMENTAL

Traditional office blood pressure monitoring in the primary care clinical environment.

Device: Blood pressure measurement device

Automated Office Blood Pressure Measurement (AOBPM)

EXPERIMENTAL

Blood pressure measurement using a validated BpTRU device

Device: Blood pressure measurement device

Home Blood Pressure Measurement (HBPM)

EXPERIMENTAL

Blood pressure measurement at patient's home using home monitoring device.

Device: Blood pressure measurement device

Interventions

Blood pressure measurement device 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).

Automated Office Blood Pressure Measurement (AOBPM); Home Blood Pressure Measurement (HBPM); Office Blood Pressure Measurement (OBPM)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Troy University: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Hypertension; White Coat Hypertension; Hypertension Resistant to Conventional Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist and Transplant Cood

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 27, 2022
• Study Start: March 5, 2021
• Primary Completion: July 5, 2021
• Study Completion: July 5, 2021
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

US (1)