- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04768946
Using Virtual Technologies to Prevent Injuries in Adolescents With Acquired Brain Injury
July 12, 2022 updated by: Amy Darragh, Ohio State University
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
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
29
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interview Questions
Time Frame: Baseline
|
Questions focus on hazard identification, injury risk, factors associated with injury risk.
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Baseline
|
Usefulness, Usability, and Desirability Assessment
Time Frame: Baseline
|
Used to fully assess the usability and appeal of the HH-VSTS, and understand potential modifications
|
Baseline
|
Hazard Rating Scale
Time Frame: Baseline
|
Hazards are categorized by frequency of exposure and severity on a two-axis grid, based on participant perceptions.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interview
Time Frame: one time administration
|
Interview questions about safety concerns and perceptions of risk regarding home environment and activity performance
|
one time administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy Darragh, PhD, Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Actual)
May 18, 2022
Study Completion (Actual)
May 18, 2022
Study Registration Dates
First Submitted
February 10, 2021
First Submitted That Met QC Criteria
February 19, 2021
First Posted (Actual)
February 24, 2021
Study Record Updates
Last Update Posted (Actual)
July 14, 2022
Last Update Submitted That Met QC Criteria
July 12, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRT00059789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data will not be shared with other researchers secondary to qualitative nature of the data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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