Stroke Clinical Trial
Official title:
Using Virtual Technologies to Prevent Injuries in Adolescents With Acquired Brain Injury (ABI)
| NCT number | NCT04768946 |
| Other study ID # | GRT00059789 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 1, 2021 |
| Est. completion date | May 18, 2022 |
| Verified date | July 2022 |
| Source | Ohio State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | May 18, 2022 |
| Est. primary completion date | May 18, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Inclusion Criteria: 1. 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 2. parent/caregiver (18+ years of age) of an adolescent with an acquired brain injury OR 3. a health professional involved in discharge planning and community re-integration of adolescents with an acquired brain injury. 4. For online interview, must have access to a computer or smart tablet with reliable internet access, a microphone, a video camera, and speakers, headphones 5. Speak and read English 6. Able to answer interviewer questions |
| Country | Name | City | State |
|---|---|---|---|
| United States | Nationwide Children's Hospital | Columbus | Ohio |
| United States | The Ohio State University | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University | Nationwide Children's Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Interview Questions | Questions focus on hazard identification, injury risk, factors associated with injury risk. | Baseline | |
| Primary | Usefulness, Usability, and Desirability Assessment | Used to fully assess the usability and appeal of the HH-VSTS, and understand potential modifications | Baseline | |
| Primary | Hazard Rating Scale | Hazards are categorized by frequency of exposure and severity on a two-axis grid, based on participant perceptions. | Baseline | |
| Secondary | Interview | Interview questions about safety concerns and perceptions of risk regarding home environment and activity performance | one time administration |
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