Accuracy of the RIVA Digital Blood Pressure Measurement App After Initial Calibration and After 24 Hours in a General Population - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Data statistical analysis
研究概览
简要总结
The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the Blood Pressure Measurement 24 hours after calibration will also be tested.
详细描述
Conventional blood pressure measurements (BPM) using a cuff-based device are actually gold standard of BPM in clinical practice. Due to availability and patient comfort, the number of such BPM is limited. Considering the large number of people using smartphones, app-based measurements and screening procedures have the potential to increase the availability of BPM and improve blood pressure control, but a prerequisite of the use of these alternative BPM methods is accuracy.
The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the BPM 24 hours after calibration will also be tested.
Before mounting the 24h-Blood Pressure (BP) monitor, a set of 11 BPM will be taken, starting with a conventional BPM using a Welch Allyn Connex® Spot Monitor, then alternating to the app, leading to 6 possible pairs of comparison. The next day, without another calibration of the app, we will take another 3 pairs of comparison (7 alternating measurements, starting with a conventional measurement). Examinators are blinded for the results of the app measurements. The app automatically sends the data of the BPM to RIVA Digital, where the results measured by the app will be processed. The staff of RIVA Digital are blinded to the conventional BPM results.
Number of Participants: 50 consecutive patients will be included in the study.
Statistical analyses: Both BPM procedures are analyzed for correlation and accuracy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •All patients undergoing a 24h-ambulatory blood pressure measurement
排除标准
- •age < 18 years
- •impossibility to sign informed consent
- •physical restrictions to Blood Pressure Measurement
结局指标
主要结局
Data statistical analysis
时间窗: 1 year
Both Blood Pressure Measurement procedures are analysed for correlation and accuracy
次要结局
未报告次要终点
