COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

Conditions
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Hypertension

Intervention / Treatment
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* Device: Aktiia Bracelet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective open-label single arm study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Aktiia bracelet<br>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. | Device: Aktiia Bracelet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic and Systolic Pressures differences between weekly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data. | Diastolic and Systolic Pressures are measured weekly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet. | 6 months | 
| Diastolic and Systolic Pressures differences between monthly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data. | Diastolic and Systolic Pressures are measured monthly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic and Systolic Pressures Circadian profiles | Analysis of the evolution of Diastolic and Systolic Pressures circadian profiles of each patient during the study. | 6 months | 
| Quality of life surveys | Participants complete the same survey at Day 30, Day 60 and Day 180 to give a feedback on participants' satisfaction and comfort regarding Aktiia product compared to Home Blood Pressure monitoring. Part of answers to surveys are based on satisfaction scales from 0 to 10 where 0 = bad and 10 = good. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension