Healthy VolunteersNCT06395350
Spire Health Remote Patient Monitor Human Factors Summative Study Protocol
A study testing Spire Health Monitor in people with Healthy Volunteers, run by Spire, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Spire Health Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2019to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Introduction and background questions: 5 minutes
- Device in-use evaluation (observations and questions): 45 minutes
- 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.
- Conditions
- Healthy Volunteers
- Being tested
- Spire Health Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spire Health MonitorDevice
Use of Health Monitor is Assessed
| Study group | Role | What they receive |
|---|---|---|
| Spire Medical Health Tag | Other | Health Monitor Use Receives: Device: Spire Health Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start4 Sep 2019
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 17 adults for whom remote monitoring has been indicated by a health professional. At least 15 usable data points will be collected.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spire, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
- Investigators
- Arthur Cabrera, MD, Principal investigator, Medical Director for Clinimark LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395350
- Sponsor's protocol ID
- PR 2019-337
- Status last verified
- Oct 2019
- First submitted
- 27 Sep 2019
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spire Health Remote Patient Monitor Human Factors Summative Study Protocol
- ClinicalTrials.gov ID
- NCT06395350
- Acronym / sponsor ID
- PR 2019-337
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Spire, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Introduction and background questions: 5 minutes
- Device in-use evaluation (observations and questions): 45 minutes
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 17 adults for whom remote monitoring has been indicated by a health professional. At least 15 usable data points will be collected.
| Arm | Type | Receives |
|---|---|---|
| Spire Medical Health Tag | Other | Device: Spire Health MonitorHealth Monitor Use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spire Health MonitorUse of Health Monitor is Assessed | Device | Spire Medical Health Tag |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Cabrera, MD principal investigator
Medical Director for Clinimark LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spire Health Monitor in people with Healthy Volunteers, run by Spire, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the participant's ability to perform essential tasks related to handling of device measured by Pass/Fail (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.