Spire Health Remote Patient Monitor Human Factors Summative Study Protocol

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT06395350

Run by

Spire, Inc.

People needed

17

Starts

2019-09-04

Expected to finish

2019-09-20

Last updated by the study team

2024-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• Wearable Fitness Device savviness

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

Where it is running

• Arthur Cabrera, MD. — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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