Use of Automated Office Blood Pressure Monitoring

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT05395403
• Collaborator: Troy University (Other)
• Enrollment: 28
• Location: 1
• Arms: 3
• Actual Duration (Months): 4
• Patients Per Site Per Month: 7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Uncontrolled Hypertension; Hypertension, White Coat; Hypertension, Resistant to Conventional Therapy	Device: Blood pressure measurement device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Use of Automated Office Blood Pressure Monitoring in Older Working-age Adults
• Actual Study Start Date: Mar 5, 2021
• Actual Primary Completion Date: Jul 5, 2021
• Actual Study Completion Date: Jul 5, 2021

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Number of participants using Traditional office blood pressure measurement (OBPM) [Baseline]

   Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg

2. Number of participants using Traditional office blood pressure measurement (OBPM) [Up to 8 weeks]

   Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg

3. Number of participants using Traditional office blood pressure measurement (OBPM) [Up to 16 weeks]

   Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg

4. Number of participants using Automated office blood pressure measurement (AOBPM) [Baseline]

   Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg

5. Number of participants using Automated office blood pressure measurement (AOBPM) [Up to 8 weeks]

   Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg

6. Number of participants using Automated office blood pressure measurement (AOBPM) [Up to 16 weeks]

   Blood pressure control: Automated office blood pressure measurement less than 130/80 mm Hg

7. Number of participants using Home blood pressure measurement (HBPM) [Baseline]

   Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg

8. Number of participants using Home blood pressure measurement (HBPM) [Up to 8 weeks]

   Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg

9. Number of participants using Home blood pressure measurement (HBPM) [Up to 16 weeks]

   Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham
• Troy University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tonya Breaux-Shropshire, Clinical Scientist and Transplant Cood, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT05395403
• Other Study ID Numbers: IRB-300006396
• First Posted: May 27, 2022
• Last Update Posted: May 27, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; White Coat Hypertension

Study Results

No Results Posted as of May 27, 2022