Patient Monitoring, Postoperative Period
Conditions
Keywords
Wellvii VitalDetect, Remote patient monitoring, Postoperative monitoring
Brief summary
This clinical trial is designed to evaluate the accuracy, usability, and patient compliance of the Wellvii VitalDetect, an FDA-cleared (510(k) K231625), Class II medical device intended for non-invasive monitoring of vital signs including blood pressure, pulse rate, and temperature. The study will focus on comparing measurements obtained in a home environment using the device to those collected in a clinical setting, with the goal of validating the device's performance for real-world, at-home use. The Wellvii VitalDetect is a portable, battery-operated, spot-check monitor that uses finger-based technology for most parameters and an infrared sensor for forehead-based, non-contact temperature readings. It is designed for use by adults (18 years or older) in a home environment and is not intended for continuous monitoring. In addition to the cleared vital signs, the device displays other wellness parameter for general health tracking. A smartphone application supports the user experience by delivering usage instructions and data display. The study will assess: * Measurement accuracy compared to standard clinical instruments * Patient ease-of-use and engagement with the device * Adherence to regular self-monitoring schedules * Overall user satisfaction and confidence I home-based monitoring This research will contribute to the growing body of evidence supporting remote patient monitoring solutions and aims to advance the adoption of decentralized technology-enabled healthcare delivery. The study aligns with Wellvii Inc.'s mission to transform healthcare delivery by enabling continuous, connected health monitoring from the home. The ultimate goal is to empower patients and healthcare providers with real-time, clinically actionable health at a that can lead to earlier intervention, improved outcomes, and reduced system burden.
Interventions
DEVICEHome-based Vital Sign Monitoring
Postoperative surgical patient will use the Wellvii VitalDetect, an FDA-cleared, non-invasive, handheld device for home-based monitoring of blood pressure, pulse rate, and temperature. After receiving training at discharge and recording baseline vital signs in clinic, participants will monitor their vital signs twice daily for two weeks using the device and a companion mobile app. Weekly clinic visits will collect corroborating data. The device does not requires calibration or maintenance and provides results in under 90 seconds. Usability and satisfaction will be assessed through questionnaires, and compliance will be monitored via app logs. Data will be automatically uploaded to a secure, de-identified database for analysis.
Sponsors
University of Alberta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinically stable patients requiring routine postoperative monitoring in the absence of any acute illness following surgery. * Able to use a smartphone or tablet for the monitoring system.
Exclusion criteria
* Severe cognitive impairment or conditions that may interfere with the use of home monitoring devices. * Currently participation in other clinical trials involving vital sign monitoring. * Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Home-Based Vital Sign Monitoring Compared to Standard Clinical Measurements | For a two-week period (twice daily) following their discharge from hospital. | This outcome measures the accuracy of vital sign readings (temperature, blood pressure, and heart rate) collected at home using the Wellvii VitalDetect™ compared to standard clinical equipment readings taken during weekly hospital visits. Accuracy will be evaluated using paired t-tests to compare mean differences between home and clinical measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Compliance with Home Monitoring Protocol | At one and two weeks post-hospital discharge | This outcome assess participant compliance with the home monitoring protocol, defined as the percentage of days during the two-week study period in which complete vital sign measurements are successfully recorded using the device and app. |
Countries
Canada
Contacts
CONTACTCarolina Archundia-Herrera, PhD
CONTACTTodd McMullen, MD
PRINCIPAL_INVESTIGATORTodd McMullen, MD
Mackenzie Health Science Centre, University of Alberta
Outcome results
None listed