EmbracePlus, Care App and Aura Usability Study

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

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.

Study Overview

• Status: Completed
• Conditions: Usability
• Intervention / Treatment: Other: Usability Assessment

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 335

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02108
      • Empatica Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy men and women over 18, based in the US, without pre-existing pathologies that can affect their physiological parameters.

Description

Inclusion Criteria:

1. Age: Participants must be between the ages of 18-99
2. Gender: No restrictions
3. Disease: healthy participants
4. Adult participant must either be able to give consent
5. Participants must be fluent in the language of the consent forms (Currently limited to English).
6. Participants must reside in the United States.
7. Participants should have a physical home address where they can receive the device
8. Participants must have a personal smartphone Apple or Android (at least iPhone 8 or Android 5.0)

Exclusion Criteria:

1. 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.
2. Participants are not willing to wear the device during nighttime
3. Participants should not have pre-existing cardiovascular disease or respiratory disease
4. Participants must not be pregnant or planning to become pregnant within two months at the time of screening

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Users; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Empatica, Inc.
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Usability; Wearable
• Other Study ID Numbers: 2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No