Continual vs. Routine Home Blood Pressure Monitoring and Management in Diverse Community Practice: CHANGE-BP

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.

Inclusion Criteria:Age 21-80 years oldOwns a smartphone that is an Android or iOS with a data planFluent in written and spoken English as the technology is currently only available in EnglishAverage 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 RecordIs a patient with Providence HealthWilling to attend the 2 in-person study visitsIs not participating in another study that is designed to influence blood pressureWilling to wear the Aktiia bracelet for 6 monthsWilling to be randomized to either groupHad a BMP in the last 12 months or is willing to get one at the discretion of the clinical pharmacist as standard of careExclusion 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 chronicCardiomyopathy with LVEF <40% documented within the past yearDiabetes MellitusUnder active treatment for hyperthyroidismMyxedema comaSubclavian stenosisPheochromocytomaRaynaud's diseaseTrembling and shiveringKnown pregnancyBreastfeedingArteriovenous fistulaArm amputationExfoliative skin diseaseLymphedemaKnown allergy to siliconeTerminal medical condition with a life expectancy less than 2 yearsCKD 4-5 (eGFR ≤ 30 mL/min)Upper arm circumference < 22 cm or > 42 cmWrist circumference < 14 cm or > 21 cmAdults unable to consent or who need a legally authorized representative to consentCurrently incarcerated or detained in accordance with federal regulations regarding prisoners (e.g., 45 CFR 46 Subpart C)Diagnosed whitecoat hypertensionOn hospice or going on hospice in the next 6-monthsCurrently undergoing or will undergo active IV infusions for chemotherapyAny condition which, at the discretion of the enrolling investigator, would preclude their ability to comply with study procedures