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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 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:

  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 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Interview Questions
Time Frame: Baseline
Questions focus on hazard identification, injury risk, factors associated with injury risk.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nationwide Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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