Back to resultsContinual vs. Routine Home Blood Pressure Monitoring and Management in Diverse Community Practice: CHANGE-BP (CHANGE-BP)
Primary Purpose
Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aktiia Device
Upper arm cuff
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Medical Device
Eligibility Criteria
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
Sites / Locations
- Providence Health & Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Continuous Blood Pressure Monitoring (CBPM)
Home Blood Pressure Monitoring (HBPM)
Arm Description
Participants will wear the Aktiia Bracelet for 6-months and potentially receive blood pressure medication titrations during the 6-month period.
Participants will receive an upper arm cuff and standard hypertension care from their primary care physician.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Participant perception
Statistics on participants' perception of an optical BP monitoring modality as compared to an oscillometric cuff
Participant engagement
Statistics on participants' engagement with the Aktiia Research System over the 6-month period
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.
Participant sociodemographics
Statistics on the sociodemographic breakdown of the sample
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05746117
Brief Title
Continual vs. Routine Home Blood Pressure Monitoring and Management in Diverse Community Practice: CHANGE-BP
Acronym
CHANGE-BP
Official Title
Continual vs. Routine Home Blood Pressure Monitoring and Management in Diverse Community Practice: CHANGE-BP
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aktiia SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Medical Device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuous Blood Pressure Monitoring (CBPM)
Arm Type
Experimental
Arm Description
Participants will wear the Aktiia Bracelet for 6-months and potentially receive blood pressure medication titrations during the 6-month period.
Arm Title
Home Blood Pressure Monitoring (HBPM)
Arm Type
Active Comparator
Arm Description
Participants will receive an upper arm cuff and standard hypertension care from their primary care physician.
Intervention Type
Device
Intervention Name(s)
Aktiia Device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Upper arm cuff
Intervention Description
A standard upper arm oscillometric cuff that can be used to take blood pressure at home.
Primary Outcome Measure Information:
Title
Change in blood pressure
Description
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
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Participant perception
Description
Statistics on participants' perception of an optical BP monitoring modality as compared to an oscillometric cuff
Time Frame
6-months
Title
Participant engagement
Description
Statistics on participants' engagement with the Aktiia Research System over the 6-month period
Time Frame
6-months
Title
Participant compliance
Description
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.
Time Frame
6-months
Title
Participant sociodemographics
Description
Statistics on the sociodemographic breakdown of the sample
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josep Sola, PhD
Phone
+41797689800
Email
josep@aktiia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Shoenkerman, MD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Health & Services
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Shoenkerman, MD
Phone
503-962-1000
Email
Aaron.Shoenkerman@providence.org
First Name & Middle Initial & Last Name & Degree
Aaron Shoenkerman, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Continual vs. Routine Home Blood Pressure Monitoring and Management in Diverse Community Practice: CHANGE-BP
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