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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Brigham and Women's Hospital | OTHER |
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The WEARABLE-BP study will evaluate the clinical value of obtaining continual measurements using the Aktiia G1 Optical Blood Pressure Monitoring (OBPM) device in hypertensive patients, compared to using a traditional upper arm cuff for home BP monitoring.
The WEARABLE-BP study aims to compare the change in unattended automated office blood pressure from baseline to 6 months between two study groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.
This is a prospective open-label two-arm randomized clinical trial (RCT). The investigational device of this study is the Aktiia G1 BP monitor.
There is an active 6- month comparison period between two BP monitoring devices, followed by a 6-month follow-up period when all patients will have an Aktiia G1 BP monitor.
Each participant will be randomly assigned to one of two study groups: Group 1, or Group 2. The randomization will be a simple, based on a single computer-generated sequence of random assignments.
During the study, the patient completes online survey covering lifestyle, health, and socioeconomic environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention | Experimental | These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period. |
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| Group 2: Traditional BP monitor (upper arm cuff) - active control | Active Comparator | These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aktiia G1 BP monitor for 12 months | Device | These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in automated unattended office BP between the two groups from baseline to 6 months | Comparison of change in automated unattended office BP (average over triplicate consecutive measurements) from baseline to 6 months between the two groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group compared to the standard treatment group | Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group (Aktiia G1 BP monitor) compared to the standard treatment group (traditional upper arm cuff), defined by unattended automated office SBP <130 mm Hg. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen Harriott | Contact | 617-525-8493 | BWHWearableBP@mgb.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass General Brigham Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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prospective open-label 2-arm study
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| Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months | Device | These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period. |
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| Difference in patient engagement and lifestyle features between the 2 groups | To test if there is a difference in patient engagement and lifestyle features between the group given an Aktiia G1 BP monitor, and those given a traditional upper arm cuff, at baseline, 6 months and 12 months based on a questionnaire | 0, 6 and 12 months |
| Difference in mean average Aktiia G1 BP measurement after a 6-month period | To compare the difference in mean average Aktiia G1 BP measurement between the first week and the last week of the six-month comparison period in the intervention group to the difference in mean Aktiia G1 BP measurement between the first and the last week of the follow-up period for the active control group. | 6 months |