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

NCT05746117 | Withdrawn FDA Device

• 1 other identifier: OBPM_CHANGE-BP2022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Medical Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Participant perception

  6-months

• Participant engagement

  6-months

• Participant compliance

  6-months

• Participant sociodemographics

  6-months

Study Arms (2)

Continuous Blood Pressure Monitoring (CBPM)

EXPERIMENTAL

Participants will wear the Aktiia Bracelet for 6-months and potentially receive blood pressure medication titrations during the 6-month period.

Device: Aktiia Device

Home Blood Pressure Monitoring (HBPM)

ACTIVE COMPARATOR

Participants will receive an upper arm cuff and standard hypertension care from their primary care physician.

Device: Upper arm cuff

Interventions

Aktiia Device 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.

Continuous Blood Pressure Monitoring (CBPM)

Upper arm cuff DEVICE

A standard upper arm oscillometric cuff that can be used to take blood pressure at home.

Home Blood Pressure Monitoring (HBPM)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aktiia SA: lead

Study Sites (1)

Providence Health & Services

Portland, Oregon, 97225, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aaron Shoenkerman, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 27, 2023
• Study Start: December 15, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 18, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)