COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

NCT ID: NCT05211648

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2023-05-23

Brief Summary

The COOL-BP study is part of the Remote Hypertension Program and will investigate the data provided by Aktiia Bracelet (a cuffless Blood Pressure monitor at the wrist) when integrated into the Remote Hypertension Program.

The COOL BP study aims to compare weekly and monthly Blood Pressure averages measured manually by traditional Home Blood Pressure Monitoring to those measured automatically by the Aktiia bracelet.

Detailed Description

This is a prospective open-label single arm study. The investigational device of this study is the Aktiia Bracelet device. Aktiia Bracelet is a non-invasive blood pressure (BP) monitor intended to track systolic and diastolic Blood Pressure trends. The Aktiia Bracelet can also measure heart rate.

Participants who consent to participate in COOL-BP will be shipped an Aktiia device to participants' residence.

For 6 months, patient will continue the procedures of the Remote Hypertension Program in parallel to wearing the Aktiia Bracelet. The Remote Hypertension Program is run remotely according to a clinical algorithm, where study navigators contact patients at regular intervals and monitor symptoms by regular phone calls; laboratory tests are obtained to ensure safety of the protocol's prescribed medications. Any symptoms will be evaluated by the program nurse practitioner or physician and managed per standard of care. During the study, the patient completes several surveys to give opinion on Aktiia product versus Home Blood Pressure Monitoring.

Following six months of using the Aktiia.product, the participant's participation in this study will end. Participants continued participation in the Remote Hypertension Program will depend on whether participants have met the blood pressure goals outlined in that program.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with Aktiia bracelet

This is a prospective open-label single arm study. Study participants will wear the Aktiia bracelet for 6 months and will continue in parallel the procedures of the Remote Hypertension Program.

Group Type: EXPERIMENTAL

Aktiia Bracelet

Intervention Type: DEVICE

Aktiia Bracelet is a CE-marked medical device that will be used in accordance with its instructions for use. The optical signals at the wrist are recorded non-invasively by means by the Aktiia bracelet. The Blood Pressure measurements are further determined from these optical signals and are compared to weekly and monthly Blood Pressure averages measured manually by traditional Home Blood Pressure Monitoring.

Interventions

Aktiia Bracelet

Aktiia Bracelet is a CE-marked medical device that will be used in accordance with its instructions for use. The optical signals at the wrist are recorded non-invasively by means by the Aktiia bracelet. The Blood Pressure measurements are further determined from these optical signals and are compared to weekly and monthly Blood Pressure averages measured manually by traditional Home Blood Pressure Monitoring.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Fluent in written and spoken English
• Already enrolled in the Remote Hypertension Program
• Average of last 3 office blood pressures >140/90 mm Hg in last 18 months OR Last office blood pressure >140/90 mm Hg in last 6 months OR Referred by MD and last 1 blood pressure >130/80 mm Hg
• Own an iPhone

Exclusion Criteria

• Tachycardia (heart rate at rest > 120bpm)
• Atrial fibrillation, persistent
• Severe heart failure (LVEF<35%)
• Pheochromocytoma
• Raynaud's disease
• Trembling and shivering
• Known pregnancy
• Breastfeeding
• Arteriovenous fistula
• Arm amputation
• Exfoliative skin disease
• Lymphoedema
• Known allergy to silicone
• Not Massachusetts resident
• Last MGB office visit >3 years
• No-MGB provider
• Terminal medical condition
• CKD 4-5 (eGFR ≤ 30 mL/mn)

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aktiia SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naomi Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School Boston MA

Locations

Harvard Medical School

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

OBPM_Remote2021

Identifier Type: -

Identifier Source: org_study_id