Hypertension
Conditions
Keywords
Hypertension, Medical Device
Brief summary
The purpose of the CHANGE-BP study is to examine the change in in-office measured Blood Pressure (BP) from baseline to end of study (6-months) between participants randomized to either 1) Continual Blood Pressure Monitoring (CBPM), which includes receiving Aktiia's novel cuffless BP Research System that has an accompanying Aktiia Patient Interface smartphone application, and care delivered through a centralized Aktiia Provider Interface that displays device data and is accessible by a health care professional or 2) Home Blood Pressure Monitoring (HBPM), which includes a standard oscillometric blood pressure cuff and the standard blood pressure management care from a participant's primary care physician.
Detailed description
This is a prospective, unblinded, open-label, randomized clinical trial that will study the use of the investigational Aktiia Bracelet and an accompanying Provider Interface in hypertension management. The Aktiia Bracelet is a non-invasive blood pressure monitor intended to track systolic and diastolic blood pressure and heart rate. Participants will attend a baseline visit, which will include a survey and blood pressure and anthropometric measurements. Participants will then be randomized to either the CBPM group, which includes the Aktiia Bracelet and care through a centralized Aktiia Provider Interface, or the HBPM group, which includes a standard blood pressure cuff and standard hypertension care. Individuals in the CBPM group will wear the Aktiia Bracelet for 6 months. During this time, a study-affiliated clinical pharmacist will monitor the individual's blood pressure through the Provider Interface and will potentially titrate the participant's blood pressure medications accordingly. After 6-months, all participants will return for an end of study visit that will include a survey and blood pressure and anthropometric measurements. Participants in the CBPM group will complete an additional survey to give their opinion on the Aktiia product.
Interventions
DEVICEAktiia Device
The Aktiia Bracelet is a CE-marked medical device that will be used in accordance with its instructions for use. The bracelet non-invasively measures optical signals at the wrist, which are used to determine blood pressure. The bracelet comes with a bluetooth enabled upper arm cuff that can be used to take on-demand blood pressure measurements. All measurements are transmitted to a dashboard that a clinical pharmacist monitors during the participant's enrollment in the study.
DEVICEUpper arm cuff
A standard upper arm oscillometric cuff that can be used to take blood pressure at home.
Sponsors
Aktiia SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 21-80 years old * Owns a smartphone that is an Android or iOS with a data plan * Fluent in written and spoken English as the technology is currently only available in English * Average of 3 BP readings in last 18 months of \>140/90 OR last in-office BP \>140/90 in the last 6 months as documented in their Electronic Health Record * Is a patient with Providence Health * Willing to attend the 2 in-person study visits * Is not participating in another study that is designed to influence blood pressure * Willing to wear the Aktiia bracelet for 6 months * Willing to be randomized to either group * Had a BMP in the last 12 months or is willing to get one at the discretion of the clinical pharmacist as standard of care
Exclusion criteria
* Blood pressure at the baseline in-office visit is too low (SBP \<140 mmHg AND DBP \<90 mmHg) OR is too high (SBP \> 190 mmHg OR DBP \> 120 mmHg) * Tachycardia (heart rate at rest \> 120bpm) * Atrial fibrillation, persistent or chronic * Cardiomyopathy with LVEF \<40% documented within the past year * Diabetes Mellitus * Under active treatment for hyperthyroidism * Myxedema coma * Subclavian stenosis * Pheochromocytoma * Raynaud's disease * Trembling and shivering * Known pregnancy * Breastfeeding * Arteriovenous fistula * Arm amputation * Exfoliative skin disease * Lymphedema * Known allergy to silicone * Terminal medical condition with a life expectancy less than 2 years * CKD 4-5 (eGFR ≤ 30 mL/min) * Upper arm circumference \< 22 cm or \> 42 cm * Wrist circumference \< 14 cm or \> 21 cm * Adults unable to consent or who need a legally authorized representative to consent * Currently incarcerated or detained in accordance with federal regulations regarding prisoners (e.g., 45 CFR 46 Subpart C) * Diagnosed whitecoat hypertension * On hospice or going on hospice in the next 6-months * Currently undergoing or will undergo active IV infusions for chemotherapy * Any condition which, at the discretion of the enrolling investigator, would preclude their ability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | 6-months | Determine if there is a statistically greater reduction in in-office measured blood pressure from baseline to 6-months in the CBPM arm when compared to the HBPM arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant perception | 6-months | Statistics on participants' perception of an optical BP monitoring modality as compared to an oscillometric cuff |
| Participant engagement | 6-months | Statistics on participants' engagement with the Aktiia Research System over the 6-month period |
| Participant compliance | 6-months | Statistics on participants' compliance, which is operationalized as the number of measurements made each day by the Aktiia Research System and the number of times the user syncs their Aktiia bracelet with the Patient Interface for the CBPM arm. Statistics on the number of upper arm cuff measurements reported to their PCP in the HBPM arm. |
| Participant sociodemographics | 6-months | Statistics on the sociodemographic breakdown of the sample |
Countries
United States
Outcome results
None listed