EmbracePlus, Care App and Aura Usability Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the usability of the system which includes the wearable device, app and cloud data processing, including an algorithm (Aura) capable of detecting possible early signs of respiratory infections in healthy individuals. In addition, the investigators would like to evaluate the presence of any allergic reactions to materials used in the manufacture of the EmbracePlus.

Detailed Description
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The investigators wish to evaluate of the usability, according to the requirements of IEC 62366-1:2015/AMD 1:2020 of a wearable device - EmbracePlus, the Empatica Care app and Aura algorithm, an early-warning wearable/AI platform for alerting to COVID-19 and other possible respiratory infections before a person is symptomatic. The system consists is a smartwatch coupled with an AI algorithm (Aura) developed by Empatica. The Aura algorithm analyzes physiological signals and derived biomarkers (such as sleep patterns) in order to detect possible early signs of respiratory infection. It has been originally developed by Empatica, validated with influenza and rhinovirus data and is being currently validated for COVID-19 infections.

Official Title
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Study for the Evaluation of the Usability of EmbracePlus, Empatica Care Platform and Aura Algorithm

Conditions
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Usability

Intervention / Treatment
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* Other: Usability Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: Participants must be between the ages of 18-99 Gender: No restrictions Disease: healthy participants Adult participant must either be able to give consent Participants must be fluent in the language of the consent forms (Currently limited to English). Participants must reside in the United States. Participants should have a physical home address where they can receive the device Participants must have a personal smartphone Apple or Android (at least iPhone 8 or Android 5.0) Exclusion Criteria: Participants must not have broken or injured skin at the wrist where EmbracePlus is worn, and they must be able to tolerate wearing EmbracePlus snugly for long periods of time. Thus, they should not have allergies to the material composition of the EmbracePlus smartwatch, or discomfort wearing a smartwatch during the night. Participants are not willing to wear the device during nighttime Participants should not have pre-existing cardiovascular disease or respiratory disease Participants must not be pregnant or planning to become pregnant within two months at the time of screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Users<br>Each subject will be provided with a wearable device (smartwatch EmbracePlus manufactured by Empatica), to be worn every day outside of work hours for a total of 6 weeks. After the 6 weeks of data collection the participant will be asked to fill an online questionnaire related to the system usability (max 20 min). | Other: Usability Assessment<br>* A survey will be administered to the subject at the end of the 6th week of product usage related to the wearable device and the related software platform's usability. Survey items will include both Likert-scale items that will be analyzed quantitatively and open-ended feedback that will be summarized qualitatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EmbracePlus, Care App and Aura Usability: Based on user survey | Determine the ease of use of the system composed of EmbracePlus, Care app and Aura algorithm and user satisfaction, by means of a survey items that include both Likert-scale items that will be analyzed quantitatively and open-ended feedback that will be summarized qualitatively. | After 6 weeks of system usage | 
| EmbracePlus, Care App and Aura safety: total number (%) of AEs and SAEs | The second primary endpoint will be the total number (%) of AEs and SAEs related to the device use | After 6 weeks of system usage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EmbracePlus, Care app and Aura reliability with different smartphones | Evaluate the reliability of the system with different brands and models of smartphone by means of participants reported bugs and problems | Single-point evaluation (baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Usability, Wearable