Spire Health Remote Patient Monitor Human Factors Summative Study Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Spire, Inc.
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Assess the participant's ability to perform essential tasks related to handling of device measured by Pass/Fail
Study Overview
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.
Detailed Description
The summative testing will address user interactions with all components of the Spire Remote Patient Monitor related to tasks associated with the user group, including the Medical Health Tags, SpireHealth Mobile Application and Healthcare Provider Dashboard. This protocol specifies the required testing methods and associated acceptance criteria, as well as other information necessary to collect that evidence.
This human factors summative test is aimed to uncover the following:
- Determine if the final system design is safe and effective for use by the intended users in the intended use environment
- Investigation of any use errors related to risk observed
- To identify any potential new use errors relating to risk Background
Empirical activities in the form of a Cognitive Expert Review Panel was conducted to evaluate design iterations on critical tasks prior to summative testing. The results of these activities were used to improve UI design and inform analytical analyses such as task analysis, PCA analysis and use error analysis (DOC-75057 Use Error Analysis) This validation includes all Spire Remote Patient Monitor system interfaces associated with the primary consumer user groups.
The Spire Remote Patient Monitor that are the subject of this validation need to be supported by the following devices:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Spire Medical Health Tag
Health Monitor Use
Intervention: Spire Health Monitor (Device)
Outcomes
Primary Outcomes
Assess the participant's ability to perform essential tasks related to handling of device measured by Pass/Fail
Time Frame: 60 minutes
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.
Secondary Outcomes
No secondary outcomes reported