Accuracy of the RIVA Digital Blood Pressure Measurement App - 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients undergoing a 24h-ambulatory blood pressure measurement

Exclusion criteria

age < 18 years
impossibility to sign informed consent
physical restrictions to Blood Pressure Measurement

Treatment and study plan

Primary outcomes

Data statistical analysis

Time frame: 1 year

Both Blood Pressure Measurement procedures are analysed for correlation and accuracy

Sponsors and collaborators

Lead sponsor

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Industry

Collaborators

University Hospital, Basel, Switzerland

Registry information

Official study title

Accuracy of the RIVA Digital Blood Pressure Measurement App After Initial Calibration and After 24 Hours in a General Population - a Pilot Study

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jul 8, 2020
Registry last updated: Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed