HypoglycemiaNCT05686590
Prehospital Provider Training With Augmented Reality (AR)
A study testing Augmented Reality Headset in people with Hypoglycemia and Pediatric ALL, run by Thomas Caruso at 2 sites in United States.
Trial summary
The goal is to evaluate the acceptance of Augmented Reality (AR) simulation as a learning modality for prehospital providers. The simulation itself is grounded in traditional best practices for simulation delivery and design as well as prior literature on simulation training for prehospital providers; the focus of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia, Pediatric ALL
- What is being tested?
- Augmented Reality Headset
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Dec 2022to 16 Dec 2022
- 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
- Trainees/ faculty working and/or volunteering at LPCH/SHC facilities as well as community based prehospital providers
- 18 years and older
Who cannot join
- Participants who do not consent
- Have a history of severe motion sickness
- Currently have nausea
- History of seizures
- Are clinically unstable
- Currently using corrective glasses (not compatible with AR headset)
- Currently pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mountain View Fire Department
Mountain View, California, 94041
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94305
About this study
Official title: Prehospital Provider Training Using Augmented Reality Simulation: A Mixed-Methods Study
The goal is to evaluate the acceptance of Augmented Reality (AR) simulation as a learning modality for prehospital providers. The simulation itself is grounded in traditional best practices for simulation delivery and design as well as prior literature on simulation training for prehospital providers; the focus of this study is the participants' experiential interaction with AR and the simulation resources.
- Conditions
- Hypoglycemia, Pediatric ALL
- Being tested
- Augmented Reality Headset
- Medical subject headings
- Hypoglycemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality HeadsetBehavioural
The simulation scenario will be a pediatric hypoglycemia-induced seizure case, which will be done through an AR simulation. AR (Augmented Reality) headset, which is a device that the participants will wear over their head and eyes and will add holographic elements to a live view of workplace training scenario.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality Enhanced Simulation (Treatment group) | Experimental | Each simulation will have between two and five participants. After consent, demographic data will be collected. Then, a study RA will fit a Magic Leap One (ML1) headsets (Magic Leap Inc., Plantation, FL) to participants. Following a scripted briefing, the instructor will also orient the participants to the ML1 headset for those in that group. After orienting the participant to the use of the headsets, the instructor will remain in a room separate from the participants, who will conduct the scenario outside. This will enable assessment of the feasibility of providing simulation instruction remotely. Prior to starting the scenario, the simulation instructor will conduct an orientation to review the core tenets of effective communication skills during prehospital care. Receives: Behavioral: Augmented Reality Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thematic Analysis of Post-Simulation Discussions
The primary aim is to study the acceptance of AR simulation amongst prehospital providers via thematic analysis of semi-structured discussions using qualitative research methods.
Measured: Duration of post-simulation debrief (15-20 minutes)
Secondary outcomes (2)
System Usability Scale (SUS)
The first secondary aim is to evaluate AR simulation usability amongst prehospital providers via the System Usability Scale (SUS).
Measured: Duration of Intervention (less than one hour)
Headset Ergonomics
The final secondary aim will evaluate the ergonomics of the headset via the ISO 9241-400 assessment of human-ergonomic factors.
Measured: Duration of Intervention (less than one hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start12 Dec 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Caruso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Caruso, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686590
- Sponsor's protocol ID
- 67544
- Status last verified
- Dec 2024
- First submitted
- 6 Jan 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Provider Training Using Augmented Reality Simulation: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT05686590
- Acronym / sponsor ID
- 67544
- Conditions
- Hypoglycemia, Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Thomas CarusoUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 17 Jan 2023 (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.
The goal is to evaluate the acceptance of Augmented Reality (AR) simulation as a learning modality for prehospital providers. The simulation itself is grounded in traditional best practices for simulation delivery and design as well as prior literature on simulation training for prehospital providers; the focus of this study is the participants' experiential interaction with AR and the simulation resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality Enhanced Simulation (Treatment group) | Experimental | Behavioral: Augmented Reality HeadsetEach simulation will have between two and five participants. After consent, demographic data will be collected. Then, a study RA will fit a Magic Leap One (ML1) headsets (Magic Leap Inc., Plantation, FL) to participants. Following a scripted briefing, the instructor will also orient the participants to the ML1 headset for those in that group. After orienting the participant to the use of the headsets, the instructor will remain in a room separate from the participants, who will conduct the scenario outside. This will enable assessment of the feasibility of providing simulation instruction remotely. Prior to starting the scenario, the simulation instructor will conduct an orientation to review the core tenets of effective communication skills during prehospital care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Trainees/ faculty working and/or volunteering at LPCH/SHC facilities as well as community based prehospital providers
- 18 years and older
Key exclusion criteria (7 listed)
- Participants who do not consent
- Have a history of severe motion sickness
- Currently have nausea
- History of seizures
- Are clinically unstable
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 |
|---|---|---|
| Augmented Reality HeadsetThe simulation scenario will be a pediatric hypoglycemia-induced seizure case, which will be done through an AR simulation. AR (Augmented Reality) headset, which is a device that the participants will wear over their head and eyes and will add holographic elements to a live view of workplace training scenario. | Behavioural | Augmented Reality Enhanced Simulation (Treatment group) |
Primary outcome
Thematic Analysis of Post-Simulation Discussions
Time frame: Duration of post-simulation debrief (15-20 minutes)
The primary aim is to study the acceptance of AR simulation amongst prehospital providers via thematic analysis of semi-structured discussions using qualitative research methods.
2 secondary outcomes
System Usability Scale (SUS)
Time frame: Duration of Intervention (less than one hour)
Headset Ergonomics
Time frame: Duration of Intervention (less than one hour)
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 16 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality Headset in people with Hypoglycemia and Pediatric ALL, run by Thomas Caruso at 2 sites 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 2 inclusion and 7 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Thematic Analysis of Post-Simulation Discussions (time frame: Duration of post-simulation debrief (15-20 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 16 Dec 2024.