Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-28 @ 4:19 PM
Study NCT ID:
NCT06395350
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2019-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spire Health Remote Patient Monitor Human Factors Summative Study Protocol
Sponsor:
Spire, Inc.
Organization:
Study Overview
Official Title:
Spire Health Remote Patient Monitor Human Factors Summative Study Protocol
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
* SpireHealth Mobile Application running on a compatible smart phone (Apple iPhone or Android phone)
* Medical Health Tag device
* Spire Healthcare Provider Dashboard running in a browser on a personal computer
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
1. Introduction and background questions: 5 minutes
2. Device in-use evaluation (observations and questions): 45 minutes
3. The final follow-up and closing: 10 minutes
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.
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:
* SpireHealth Mobile Application running on a compatible smart phone (Apple iPhone or Android phone)
* Medical Health Tag device
* Spire Healthcare Provider Dashboard running in a browser on a personal computer
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
1. Introduction and background questions: 5 minutes
2. Device in-use evaluation (observations and questions): 45 minutes
3. The final follow-up and closing: 10 minutes
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: