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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2022
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio
United States The Ohio State University Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

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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