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Completed

NCT Number: NCT05395403

Use of Automated Office Blood Pressure Monitoring

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Baseline

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

  8. Number of participants using Home blood pressure measurement (HBPM)

    Time frame: 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)

    Time frame: Up to 16 weeks

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Troy University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 27, 2022
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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