WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
Aktiia SA
Summary
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.
Description
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. * Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention 82 participants. These p…
Eligibility
- Age range
- 21–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults aged 21 to 85 years. * Able to read and speak English. * Have an MGB provider and medical record number in EPIC * Study participants will wear the Aktiia bracelet for 6 months * Willing to attend two on-site study visits and comply with all study procedures. * Signed informed consent provided. * Own a smartphone with iOS or Android operating system. * Hypertensive with uncontrolled systolic blood pressure (SBP) \>135 mm Hg by unattended automated office measurement * Currently taking 0, 1 or 2 antihypertensive medications. Exclusion Criteria: * Severe hypertensi…
Interventions
- DeviceAktiia G1 BP monitor for 12 months
These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
- DeviceTraditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months
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.
Location
- Mass General Brigham HospitalBoston, Massachusetts