HypertensionNCT05395403
Use of Automated Office Blood Pressure Monitoring
A study testing Blood pressure measurement device in people with Hypertension and Uncontrolled Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Uncontrolled Hypertension, Hypertension, White Coat
- What is being tested?
- Blood pressure measurement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 5 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Use of Automated Office Blood Pressure Monitoring in Older Working-age Adults
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
- Being tested
- Blood pressure measurement device
- Medical subject headings
- Hypertension, White Coat Hypertension, Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurement deviceDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Office Blood Pressure Measurement (OBPM) | Experimental | Traditional office blood pressure monitoring in the primary care clinical environment. Receives: Device: Blood pressure measurement device |
| Automated Office Blood Pressure Measurement (AOBPM) | Experimental | Blood pressure measurement using a validated BpTRU device Receives: Device: Blood pressure measurement device |
| Home Blood Pressure Measurement (HBPM) | Experimental | Blood pressure measurement at patient's home using home monitoring device. Receives: Device: Blood pressure measurement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants using Traditional office blood pressure measurement (OBPM)
Blood pressure control: Traditional office blood pressure measurement less than 140/90 mm Hg
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Number of participants using Home blood pressure measurement (HBPM)
Blood pressure control: Home blood pressure measurement less than 130/80 mm Hg
Measured: 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
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start5 Mar 2021
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Troy University
- Responsible party
- Principal investigator, Tonya Breaux-Shropshire, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395403
- Sponsor's protocol ID
- IRB-300006396
- Status last verified
- May 2022
- First submitted
- 19 Apr 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Automated Office Blood Pressure Monitoring in Older Working-age Adults
- ClinicalTrials.gov ID
- NCT05395403
- Acronym / sponsor ID
- IRB-300006396
- Conditions
- Hypertension, Uncontrolled Hypertension, Hypertension, White Coat, Hypertension, Resistant to Conventional Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Troy University
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Office Blood Pressure Measurement (OBPM) | Experimental | Device: Blood pressure measurement deviceTraditional office blood pressure monitoring in the primary care clinical environment. |
| Automated Office Blood Pressure Measurement (AOBPM) | Experimental | Device: Blood pressure measurement deviceBlood pressure measurement using a validated BpTRU device |
| Home Blood Pressure Measurement (HBPM) | Experimental | Device: Blood pressure measurement deviceBlood pressure measurement at patient's home using home monitoring device. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure measurement deviceThe 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). | Device | Automated Office Blood Pressure Measurement (AOBPM), Home Blood Pressure Measurement (HBPM), Office Blood Pressure Measurement (OBPM) |
Primary outcome
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure measurement device in people with Hypertension and Uncontrolled Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants using Traditional office blood pressure measurement (OBPM) (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.