Acquired Brain InjuryNCT04768946
Using Virtual Technologies to Prevent Injuries in Adolescents With Acquired Brain Injury
An observational study of Acquired Brain Injury and Traumatic Brain Injury, run by Ohio State University at 2 sites in United States.
Trial summary
The objective of this study is to identify home safety hazards for adolescents with acquired brain injury and to identify adaptations to the home healthcare virtual simulation training system (HH-VSTS) to improve the user experience for adolescents with ABI Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury, Traumatic Brain Injury, Stroke
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2021to 18 May 2022
- Phase
- Observational
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will include adolescents with an acquired brain injury between the ages of 12 - 17, parents/caregivers of adolescents with an acquired brain injury, and a health professional involved in discharge planning and community re-integration of adolescents with an acquired brain injury.
Who may be able to join
- adolescent with an acquired brain injury between the ages of 12 - 17 (TBI diagnosis per medical record or self-report for those recruited via word of mouth or community) OR
- parent/caregiver (18+ years of age) of an adolescent with an acquired brain injury OR
- a health professional involved in discharge planning and community re-integration of adolescents with an acquired brain injury.
- For online interview, must have access to a computer or smart tablet with reliable internet access, a microphone, a video camera, and speakers, headphones
- Speak and read English
- Able to answer interviewer questions
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nationwide Children's Hospital
Columbus, Ohio, 43205
The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: Using Virtual Technologies to Prevent Injuries in Adolescents With Acquired Brain Injury (ABI)
The objective of this study is to identify home safety hazards for adolescents with acquired brain injury and to identify adaptations to the home healthcare virtual simulation training system (HH-VSTS) to improve the user experience for adolescents with ABI
Read the detailed description
This study will determine the home safety hazards that place adolescents with ABI at risk of injury. In addition, the study will determine ways to adapt our current home safety virtual simulation training system, a game based training and assessment that trains home healthcare workers to identify and respond to hazards they encounter in client homes. The study will include interviews with three stakeholders groups: adolescents with ABI, parents of adolescents with ABI, and healthcare providers working with adolescents with ABI to identify home safety hazards encountered by adolescents with ABI. We will demonstrate proof of concept for adolescents with ABI through assessment of safety concerns from multiple perspectives and evaluation of design considerations from our intended user-group. Further, we are applying the HH-VSTS in a novel way to solve an understudied problem in adolescents with ABI. In addition, we will apply a user-centered, participatory approach to assess the design consideration of virtual gaming technologies to health and safety training adolescents with ABI.
- Conditions
- Acquired Brain Injury, Traumatic Brain Injury, Stroke
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with Acquired Brain Injury | Adolescents with traumatic brain injury, stroke, and other acquired brain injury ages 12 - 17 will participate in interviews about home safety. They also will have the opportunity to look at and, if desired, try the virtual simulation training system and provide feedback about how to make it more appropriate for adolescents with brain injury, including gamifying it and ensuring appropriate hazards. | |
| Caregivers of Adolescents with Acquired Brain Injury | Caregivers of adolescents with traumatic brain injury, stroke, and other acquired brain injury will participate in interviews about home safety. They also will have the opportunity to look at the virtual simulation training system and provide feedback about how to make it more appropriate for adolescents with brain injury, including gamifying it and ensuring appropriate hazards. | |
| Healthcare Workers | This cohort includes health professionals involved in discharge planning and community re-integration of adolescents with ABI. Healthcare workers will participate in interviews about home safety. They also will have the opportunity to look at the virtual simulation training system and provide feedback about how to make it more appropriate for adolescents with brain injury, including gamifying it and ensuring appropriate hazards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview Questions
Questions focus on hazard identification, injury risk, factors associated with injury risk.
Measured: Baseline
Usefulness, Usability, and Desirability Assessment
Used to fully assess the usability and appeal of the HH-VSTS, and understand potential modifications
Measured: Baseline
Hazard Rating Scale
Hazards are categorized by frequency of exposure and severity on a two-axis grid, based on participant perceptions.
Measured: Baseline
Secondary outcomes (1)
Interview
Interview questions about safety concerns and perceptions of risk regarding home environment and activity performance
Measured: one time administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 May 2021
- Primary completion18 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Principal investigator, Amy Darragh, Ohio State University
- Investigators
- Amy Darragh, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768946
- Sponsor's protocol ID
- GRT00059789
- Status last verified
- Jul 2022
- First submitted
- 10 Feb 2021
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with other researchers secondary to qualitative nature of the data.
Publications
Anderson SE, Schroedle S, Stamper T, Lundine JP, Patterson ES, DiGiovine CP, Swearingen S, Wengerd LR, Darragh AR. 'I just don't want them to be my patient again': an exploratory mixed-methods study examining provider home safety concerns for adolescents with acquired brain injuries in the US Midwest. Inj Prev. 2026 Mar 27;32(2):309-316. doi: 10.1136/ip-2024-045326.
PubMed 39532313
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Technologies to Prevent Injuries in Adolescents With Acquired Brain Injury (ABI)
- ClinicalTrials.gov ID
- NCT04768946
- Acronym / sponsor ID
- GRT00059789
- Conditions
- Acquired Brain Injury, Traumatic Brain Injury, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 24 Feb 2021 (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 objective of this study is to identify home safety hazards for adolescents with acquired brain injury and to identify adaptations to the home healthcare virtual simulation training system (HH-VSTS) to improve the user experience for adolescents with ABI
Detailed description
This study will determine the home safety hazards that place adolescents with ABI at risk of injury. In addition, the study will determine ways to adapt our current home safety virtual simulation training system, a game based training and assessment that trains home healthcare workers to identify and respond to hazards they encounter in client homes. The study will include interviews with three stakeholders groups: adolescents with ABI, parents of adolescents with ABI, and healthcare providers working with adolescents with ABI to identify home safety hazards encountered by adolescents with ABI. We will demonstrate proof of concept for adolescents with ABI through assessment of safety concerns from multiple perspectives and evaluation of design considerations from our intended user-group. Further, we are applying the HH-VSTS in a novel way to solve an understudied problem in adolescents with ABI. In addition, we will apply a user-centered, participatory approach to assess the design consideration of virtual gaming technologies to health and safety training adolescents with ABI.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescents with Acquired Brain Injury | – | –Adolescents with traumatic brain injury, stroke, and other acquired brain injury ages 12 - 17 will participate in interviews about home safety. They also will have the opportunity to look at and, if desired, try the virtual simulation training system and provide feedback about how to make it more appropriate for adolescents with brain injury, including gamifying it and ensuring appropriate hazards. |
| Caregivers of Adolescents with Acquired Brain Injury | – | –Caregivers of adolescents with traumatic brain injury, stroke, and other acquired brain injury will participate in interviews about home safety. They also will have the opportunity to look at the virtual simulation training system and provide feedback about how to make it more appropriate for adolescents with brain injury, including gamifying it and ensuring appropriate hazards. |
| Healthcare Workers | – | –This cohort includes health professionals involved in discharge planning and community re-integration of adolescents with ABI. Healthcare workers will participate in interviews about home safety. They also will have the opportunity to look at the virtual simulation training system and provide feedback about how to make it more appropriate for adolescents with brain injury, including gamifying it and ensuring appropriate hazards. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include adolescents with an acquired brain injury between the ages of 12 - 17, parents/caregivers of adolescents with an acquired brain injury, and a health professional involved in discharge planning and community re-integration of adolescents with an acquired brain injury.
Key inclusion criteria (6 listed)
- adolescent with an acquired brain injury between the ages of 12 - 17 (TBI diagnosis per medical record or self-report for those recruited via word of mouth or community) OR
- parent/caregiver (18+ years of age) of an adolescent with an acquired brain injury OR
- a health professional involved in discharge planning and community re-integration of adolescents with an acquired brain injury.
- For online interview, must have access to a computer or smart tablet with reliable internet access, a microphone, a video camera, and speakers, headphones
- Speak and read English
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interview Questions
Time frame: Baseline
Questions focus on hazard identification, injury risk, factors associated with injury risk.
Usefulness, Usability, and Desirability Assessment
Time frame: Baseline
Used to fully assess the usability and appeal of the HH-VSTS, and understand potential modifications
Hazard Rating Scale
Time frame: Baseline
Hazards are categorized by frequency of exposure and severity on a two-axis grid, based on participant perceptions.
1 secondary outcome
Interview
Time frame: one time administration
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 14 Jul 2022.
- Derived from this study: PubMed 39532313Anderson SE, Schroedle S, Stamper T, Lundine JP, Patterson ES, DiGiovine CP, Swearingen S, Wengerd LR, Darragh AR. 'I just don't want them to be my patient again': an exploratory mixed-methods study examining provider home safety concerns for adolescents with acquired brain injuries in the US Midwest. Inj Prev. 2026 Mar 27;32(2):309-316. doi: 10.1136/ip-2024-045326.
- Individual participant dataSharing planned: No. Data will not be shared with other researchers secondary to qualitative nature of the data.
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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.
Amy Darragh, PhD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Brain Injury and Traumatic Brain Injury, run by Ohio State University 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 6 inclusion and 0 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 14 Jul 2022. 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?
Interview Questions (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04768946, which also lists 1 linked publication.
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 14 Jul 2022.