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

NCT05746117 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-02-18

No results posted yet for this study

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

Interventions

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.

DEVICE

Upper arm cuff

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

Sponsors & Collaborators

  • Aktiia SA

    lead INDUSTRY

Principal Investigators

  • Aaron Shoenkerman, MD · Providence Health & Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-15
Primary Completion
2026-05-31
Completion
2026-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05746117 on ClinicalTrials.gov