Use of Automated Office Blood Pressure Monitoring

NCT ID: NCT05395403

Last Updated: 2022-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2021-07-05

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Office Blood Pressure Measurement (OBPM)

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

Group Type EXPERIMENTAL

Blood pressure measurement device

Intervention Type 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)

Blood pressure measurement using a validated BpTRU device

Group Type EXPERIMENTAL

Blood pressure measurement device

Intervention Type 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).

Home Blood Pressure Measurement (HBPM)

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

Group Type EXPERIMENTAL

Blood pressure measurement device

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Troy University

UNKNOWN

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Tonya Breaux-Shropshire

Clinical Scientist and Transplant Cood

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-300006396

Identifier Type: -

Identifier Source: org_study_id

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