Spire Health Remote Patient Monitor Human Factors Summative Study Protocol

NCT06395350 | Completed FDA Device

• 1 other identifier: PR 2019-337
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This usability validation testing protocol outlines the methods being used to demonstrate and gather evidence that the current design and user experience of the Spire Remote Patient Monitor are safe and effective for use by the people who are representative of the intended users under expected use conditions. This summative testing is the culmination of several preliminary analyses including a formative usability evaluation via Cognitive Expert Review Panel and is intended to assess the effectiveness of control measures put in place to reduce/eliminate use-related hazards or potential use errors.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Assess the participant's ability to perform essential tasks related to handling of device measured by Pass/Fail

  Observational techniques will be used to assess the participant's ability to easily use various features on the device and discover whether user errors occur.

  60 minutes

Study Arms (1)

Spire Medical Health Tag

OTHER

Health Monitor Use

Device: Spire Health Monitor

Interventions

Spire Health Monitor DEVICE

Use of Health Monitor is Assessed

Spire Medical Health Tag

Eligibility Criteria

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

You may qualify if:

• Must indicate that they are interested in using a smartphone and/or wearable fitness device for tracking their health
• High school degree or equivalent (e.g., GED) or less - at least 2
• Some college but no degree or associate degree - at least 4
• Age 22-49 - at least 5
• Age 50-65 - at least 5
• Age Over 65 - at least 2
• Near even split of men and women
• Almost never limited by my physical condition
• Rarely limited by my physical condition
• Occasionally limited by my physical condition
• Often limited by my physical condition
• Almost always limited by my physical condition
• Users with iPhone experience
• Smart Phone Savviness
• No more than 7 users who own use a wearable fitness device

You may not qualify if:

• Participant currently works in tech industry
• Participant or a member of his/her household currently works for any company that develops, manufactures, or sells smartphones or smart wearable fitness devices
• Participant has participated in market or user research related to a medical device within the last 6 months and has participated in more than 2 in the last 3 years
• Participants are trained clinicians or healthcare providers

Sponsors & Collaborators

• Spire, Inc.: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Arthur Cabrera, MD.

Louisville, Colorado, 80027, United States

Location

Study Officials

• Arthur Cabrera, MD

  Medical Director for Clinimark LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 17 adults for whom remote monitoring has been indicated by a health professional. At least 15 usable data points will be collected.

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: May 2, 2024
• Study Start: September 4, 2019
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: May 2, 2024

Record last verified: 2019-10

Locations

US (1)