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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Monitoring - Surgical Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based Vital Sign Monitoring | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Home-Based Vital Sign Monitoring Compared to Standard Clinical Measurements | 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. | For a two-week period (twice daily) following their discharge from hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Compliance with Home Monitoring Protocol | 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. | At one and two weeks post-hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with Home Monitoring Protocol | Satisfaction will be assessed using a Likert-scale questionnaire. The questionnaire evaluates overall satisfaction with the device. | At the one-week and two-week clinic visits |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing surgical procedures, including day surgery procedures and those procedures requiring a hospital stay
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Archundia-Herrera, PhD | Contact | (587) 982-6635 | archundi@ualberta.ca | |
| Todd McMullen, MD | Contact | (780) 407-1108 | tpm1@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Todd McMullen, MD | Mackenzie Health Science Centre, University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackenzie Health Science Centre | Edmonton | Alberta | T6G 2B7 | Canada |
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