Using Virtual Technologies to Prevent Injuries in Adolescents With Acquired Brain Injury

Sponsor

Ohio State University (Other)

Overall Status

Completed

CT.gov ID

NCT04768946

Collaborator

Nationwide Children's Hospital (Other)

Enrollment

Locations

12.6

Actual Duration (Months)

14.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Acquired Brain Injury Traumatic Brain Injury Stroke

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

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Using Virtual Technologies to Prevent Injuries in Adolescents With Acquired Brain Injury (ABI)

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

May 18, 2022

Actual Study Completion Date :

May 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Interview Questions [Baseline]
Questions focus on hazard identification, injury risk, factors associated with injury risk.
Usefulness, Usability, and Desirability Assessment [Baseline]
Used to fully assess the usability and appeal of the HH-VSTS, and understand potential modifications
Hazard Rating Scale [Baseline]
Hazards are categorized by frequency of exposure and severity on a two-axis grid, based on participant perceptions.

Secondary Outcome Measures

Interview [one time administration]
Interview questions about safety concerns and perceptions of risk regarding home environment and activity performance

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
2	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University
Nationwide Children's Hospital

Investigators

Principal Investigator: Amy Darragh, PhD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amy Darragh, Associate Professor, Ohio State University

ClinicalTrials.gov Identifier:

NCT04768946

Other Study ID Numbers:

GRT00059789

First Posted:

Feb 24, 2021

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Wounds and Injuries

Study Results

No Results Posted as of Jul 14, 2022