COOL-BP Study: Continuous Versus Occasional Blood Pressure Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aktiia SA
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Diastolic and Systolic Pressures differences between monthly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 26 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Aktiia Bracelet (Device)
结局指标
主要结局
Diastolic and Systolic Pressures differences between monthly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.
时间窗: 6 months
Diastolic and Systolic Pressures are measured monthly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet.
Diastolic and Systolic Pressures differences between weekly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.
时间窗: 6 months
Diastolic and Systolic Pressures are measured weekly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet.
次要结局
- Diastolic and Systolic Pressures Circadian profiles(6 months)
- Quality of life surveys(6 months)