NCT04768946

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

February 10, 2021

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Interview Questions

    Questions focus on hazard identification, injury risk, factors associated with injury risk.

    Baseline

  • Usefulness, Usability, and Desirability Assessment

    Used to fully assess the usability and appeal of the HH-VSTS, and understand potential modifications

    Baseline

  • Hazard Rating Scale

    Hazards are categorized by frequency of exposure and severity on a two-axis grid, based on participant perceptions.

    Baseline

Secondary Outcomes (1)

  • Interview

    one time administration

Study Arms (3)

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.

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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. 2024 Nov 11:ip-2024-045326. doi: 10.1136/ip-2024-045326. Online ahead of print.

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, TraumaticStroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Amy Darragh, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 24, 2021

Study Start

May 1, 2021

Primary Completion

May 18, 2022

Study Completion

May 18, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Data will not be shared with other researchers secondary to qualitative nature of the data.

Locations