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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Device: Aktiia Device; Device: Upper arm cuff

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josep Sola, PhD; Phone Number: +41797689800; Email: josep@aktiia.com

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Health & Services
      • Contact: Aaron Shoenkerman, MD; Phone Number: 503-962-1000; Email: Aaron.Shoenkerman@providence.org
      • Principal Investigator: Aaron Shoenkerman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Blood Pressure Monitoring (CBPM); Participants will wear the Aktiia Bracelet for 6-months and potentially receive blood pressure medication titrations during the 6-month period.	Device: Aktiia 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.
Active Comparator: Home Blood Pressure Monitoring (HBPM); Participants will receive an upper arm cuff and standard hypertension care from their primary care physician.	Device: Upper arm cuff; A standard upper arm oscillometric cuff that can be used to take blood pressure at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	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	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant perception	Statistics on participants' perception of an optical BP monitoring modality as compared to an oscillometric cuff	6-months
Participant engagement	Statistics on participants' engagement with the Aktiia Research System over the 6-month period	6-months
Participant compliance	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.	6-months
Participant sociodemographics	Statistics on the sociodemographic breakdown of the sample	6-months

Collaborators and Investigators

• Sponsor: Aktiia SA
• Investigators: Principal Investigator: Aaron Shoenkerman, MD, Providence Health & Services

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Medical Device
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: OBPM_CHANGE-BP2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No