Comparing Home Blood Pressure Measurements from Devices with and Without Evidence of Validation to Ambulatory Blood Pressure Monitoring: the VALID-HomeBP Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mean difference in systolic BP
研究概览
简要总结
This study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake BP from ambulatory blood pressure monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged > 18 years scheduled to undergo an ABPM
排除标准
- •Upper arm size outside of cuff range of selected devices (<22 cm or >42 cm)
- •Night shift workers
- •Permanent atrial fibrillation
- •Known severe aortic stenosis
- •Contraindication to measure BP on the non-dominant arm
- •Ongoing pregnancy
- •Inability or unwillingness to provide consent
研究组 & 干预措施
Non-validated home BP device #1
BP measured with the first non-validated home BP device
干预措施: awake ABPM (Diagnostic Test)
Non-validated home BP device #2
BP measured with the second non-validated home BP device
干预措施: awake ABPM (Diagnostic Test)
Non-validated home BP device #3
BP measured with the third non-validated home BP device
干预措施: awake ABPM (Diagnostic Test)
Validate home BP device
BP measured with a validated home BP device
干预措施: awake ABPM (Diagnostic Test)
结局指标
主要结局
Mean difference in systolic BP
时间窗: At enrollment (time 0)
Mean difference in systolic BP between the home BP device and the awake ABPM
次要结局
- Mean difference in systolic BP from validated device(At enrollment (time 0))
- Mean difference in diastolic BP from validated device(At enrollment (time 0))
- Mean difference in diastolic BP(At enrollment (time 0))
研究者
Remi Goupil, MD MSc
Principal investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal