An interventional study of Spire Health Monitor in Healthy Volunteers, sponsored by Spire, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by Spire, Inc. · Not applicable, Interventional, and Other
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.
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:
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:
Prior to this summative testing there will be no training activities. Support and help are embedded within the app experience and Instructions for Use (IFU).
Seventeen (17) users will be recruited who comprise the single Spire Remote Patient Monitor user group: adults for whom remote monitoring has been indicated by a health professional. At least 15 usable data points will be collected. This sample size is based on the recommendation number of participants in IEC 62366: 2015, Part 1 and Part 2. The increased participant size is also to allow for cancellations and other test anomalies (e.g., equipment failures).
Session Description: 60 minutes, one-on-one session
Session Activities
The Facilitator's Script is allows for consistent interaction between the facilitators and the participants. As per the facilitator's discretion, any deviation to the exact script will be based on real-time responses to the session flow and responding the individual interaction. The script will have a list of questions specific to each scenario designed to help the facilitator/observer refine the information, to improve consistency of reporting, and assist the facilitator/observer in root cause analysis.
Spire, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Health Monitor Use
Device: Spire Health Monitor
Use of Health Monitor is Assessed
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.
Time frame: 60 minutes
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Spire, Inc.