Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL139716 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Columbia University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of the proposed study is to test whether measuring unattended blood pressure using an automated blood pressure monitor in a clinic setting without staff being present can reduce the need for assessing out-of- clinic awake blood pressure using ambulatory monitoring. Also, the investigators will test whether asleep blood pressure can be accurately measured using a novel home blood pressure monitoring device with less burden compared with ambulatory monitoring.
For many people, blood pressure levels differ when measured in a doctor's office versus during normal daily activities. Ambulatory blood pressure monitoring, also called ABPM, involves wearing a blood pressure cuff attached to a device that is programmed to measure participants blood pressure every 30 minutes for a 24-hour period. ABPM can help better estimate a person's true average blood pressure. Although ABPM is recommended for diagnosing high blood pressure and it also measures blood pressure while people sleep, it is not available in many clinics and some people find the procedure to be uncomfortable. The purpose of this research study is to test whether blood pressure measured in a clinic setting without medical staff present is comparable to blood pressure levels measured during the daytime measured using an ABPM device. Also, the investigators will test whether asleep blood pressure can be accurately measured using a home blood pressure monitoring device. These findings may help identify new approaches for diagnosing high blood pressure without the need for ABPM. Each participant will complete four study visits. During the course of the study, participants will:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unattended vs Attended Blood Pressure | Other | Participants blood pressure will be measured three times attended and three times unattended using the Microlife WatchBP Office AFIB device. Whether investigators measure blood pressure attended first and then unattended or unattended first and then attended will be assigned using a random number generator. At visit 2, clinic blood pressure will be measured three times attended and three times unattended using the Microlife WatchBP Office AFIB device, as at visit 1, but in the reverse order. |
|
| ABPM vs HBPM | Other | Participants will be fitted with either the Microlife WatchBP O3 ambulatory blood pressure monitoring device or instructed on how to use the Microlife WatchBP Home N home blood pressure device, depending on which they are assigned to complete first. The order in which participants undergo ambulatory or home blood pressure monitoring will be assigned through a random number generator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unattended blood pressure measurement | Other | Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician not present in the room. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Difference Between Unattended and Attended Blood Pressure | The difference between both systolic and diastolic blood pressure measurements when a technician is present versus when they are not present in the room. | 2 days |
| Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor | Participants will have their systolic and diastolic blood pressure measured overnight using a home blood pressure monitor and over 24-hours using an ambulatory blood pressure monitor. | 2 days |
| Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Participants will complete questionnaires regarding their experience wearing both the ambulatory and home blood pressure monitors as well as a questionnaire on their willingness to wear the devices again. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Mass Index | Mean left ventricular mass index (LVMI) | 3 days |
| Urinary Albumin-to-creatine Ratio | Mean urinary albumin-to-creatinine ratio (UACR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Muntner, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Hypertension Research Clinic | Birmingham | Alabama | 35205 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35667722 | Derived | Cepeda M, Hubbard D, Oparil S, Schwartz JE, Jaeger BC, Hardy ST, Medina J, Chen L, Muntner P, Shimbo D. Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study - a randomised, crossover trial. BMJ Open. 2022 Jun 6;12(6):e058140. doi: 10.1136/bmjopen-2021-058140. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 1,095 participants screened, 654 met the inclusion criteria and were randomized to either attended (technician present) before unattended (technician absent) blood pressure measurements or unattended before attended blood pressure measurements. The 654 participants were also randomized to undergo either Ambulatory Blood Pressure Monitoring before Home Blood Pressure Monitoring or Home Blood Pressure Monitoring before Ambulatory Blood Pressure Monitoring.
This study enrolled participants whose systolic and diastolic blood pressure were 110 mm Hg to < 160 mm Hg and 70 mm Hg to <100 mm Hg, respectively, during screening. Participants were enrolled from a hypertension research clinic at the University of Alabama at Birmingham and a hypertension center at the Columbia University Medical Center. The first participant was enrolled on 7/15/2019 and the last participant was enrolled in 11/28/2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Attended Before Unattended BP | During visit 1, participants' clinic blood pressure was measured three times attended (i.e., in the presence of a technician) and then three times unattended (i.e., in the absence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times unattended and then three times attended. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization 1 |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Attended blood pressure measurement | Other | Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician present in the room. |
|
|
| Ambulatory blood pressure monitoring | Other | Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor. |
|
|
| Home blood pressure monitoring | Other | Participants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor. |
|
|
| 3 days |
| Columbia University Medical Center - Hypertension Center |
| New York |
| New York |
| 10032 |
| United States |
| FG001 | Unattended Before Attended BP | During visit 1, participants' clinic blood pressure was measured three times unattended (i.e., in the absence of a technician) and then three times attended (i.e., in the presence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times attended and then three times unattended. |
| FG002 | Ambulatory Blood Pressure Monitoring (ABPM) Before Home Blood Pressure Monitoring (HBPM) | During visit 2, participants underwent 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) before undergoing one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) in visit 3. |
| FG003 | Home Blood Pressure Monitoring (HBPM) Before Ambulatory Blood Pressure Monitoring (ABPM) | During visit 2, participants underwent one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) before undergoing 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) in visit 3. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Randomization 2 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Attended Before Unattended BP | During visit 1, participants' clinic blood pressure was measured three times attended (i.e., in the presence of a technician) and then three times unattended (i.e., in the absence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times unattended and then three times attended. |
| BG001 | Unattended Before Attended BP | During visit 1, participants' clinic blood pressure was measured three times unattended (i.e., in the absence of a technician) and then three times attended (i.e., in the presence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times attended and then three times unattended. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Self-reported Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Sel-reported High Cholesterol | Count of Participants | Participants |
| ||||||||||||||||
| Sef-reported Diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Self-reported Asthma or Hey Fever | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Difference Between Unattended and Attended Blood Pressure | The difference between both systolic and diastolic blood pressure measurements when a technician is present versus when they are not present in the room. | Participants with complete attended and unattended blood pressure data. | Posted | Mean | Standard Deviation | mm Hg | 2 days |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor | Participants will have their systolic and diastolic blood pressure measured overnight using a home blood pressure monitor and over 24-hours using an ambulatory blood pressure monitor. | Participants with complete ambulatory and home blood pressure monitoring data. | Posted | Mean | Standard Deviation | mm Hg | 2 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires | Participants will complete questionnaires regarding their experience wearing both the ambulatory and home blood pressure monitors as well as a questionnaire on their willingness to wear the devices again. | Participants who completed questionnaires regarding their experiences wearing both the ambulatory and home blood pressure monitors. | Posted | Count of Participants | Participants | 3 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular Mass Index | Mean left ventricular mass index (LVMI) | Posted | Mean | Standard Deviation | g/m^2 | 3 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Urinary Albumin-to-creatine Ratio | Mean urinary albumin-to-creatinine ratio (UACR) | Posted | Mean | Standard Deviation | mg/g | 3 days |
|
2 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attended Before Unattended BP | During visit 1, participants' clinic blood pressure was measured three times attended (i.e., in the presence of a technician) and then three times unattended (i.e., in the absence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times unattended and then three times attended. | 0 | 326 | 0 | 326 | 0 | 326 |
| EG001 | Unattended Before Attended BP | During visit 1, participants' clinic blood pressure was measured three times unattended (i.e., in the absence of a technician) and then three times attended (i.e., in the presence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times attended and then three times unattended. | 0 | 328 | 0 | 328 | 0 | 328 |
| EG002 | Ambulatory Blood Pressure Monitoring (ABPM) Before Home Blood Pressure Monitoring (HBPM) | During visit 2, participants underwent 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) before undergoing one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) in visit 3. | 0 | 330 | 0 | 330 | 228 | 330 |
| EG003 | Home Blood Pressure Monitoring (HBPM) Before Ambulatory Blood Pressure Monitoring (ABPM) | During visit 2, participants underwent one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) before undergoing 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) in visit 3. | 0 | 324 | 0 | 324 | 244 | 324 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brusing | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Heavy to wear monitor | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily B. Levitan, Professor and Vice Chair | University of Alabama at Birmingham | (205) 975-7680 | elevitan@uab.edu |
| Jul 22, 2024 |
| Prot_SAP_000.pdf |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Paired T Test, 2-sided |
| < 0.0001 |
The threshold for statistical significance was p = 0.05 |
| Mean Difference (Final Values) |
| 0.5 |
| 2-Sided |
| 95 |
| 0.3 |
| 0.7 |
Mean difference in diastolic blood pressure = mean diastolic blood pressure when attended - mean diastolic blood pressure when not attended (i.e., unattended) |
| Superiority |
Asleep diastolic blood pressure collected with a home blood pressure monitoring device. |
|
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|