Use of Automated Office Blood Pressure Monitoring

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395403
• Other study ID #: IRB-300006396
• Status: Completed
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: July 5, 2021

Study information

• Verified date: May 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 5, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Troy University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of participants using Home blood pressure measurement (HBPM)	Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg	Baseline
Primary	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
Primary	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