EmbracePlus, Care App and Aura Usability Study

NCT04807608 | Completed

• 1 other identifier: 2021-001
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Usability

Keywords

Usability; Wearable

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• EmbracePlus, Care app and Aura reliability with different smartphones

  Single-point evaluation (baseline)

Study Arms (1)

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

Interventions

Usability Assessment OTHER

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.

Healthy Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Empatica, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (1)

Empatica Inc

Boston, Massachusetts, 02108, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: May 31, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)