Blood Pressure Clinical Trial
Official title:
Accuracy of the RIVA Digital Blood Pressure Measurement App After Initial Calibration and After 24 Hours in a General Population - a Pilot Study
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.
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.
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