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Bridging Recovery Allies in Virtual Environments (BRAVE)

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Envrionment for Social Communication
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Traumatic Brain Injury focused on measuring Virtual Environments, Social Communication

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subjects with a traumatic brain injury
  • between the age of 18 and 80
  • living in the community
  • able to read and speak English,
  • are more than 1-year post-injury
  • are accessible by phone,
  • report independent computer usage over the last 6 months
  • have access to a computer meeting minimum specifications for the Learning in Virtual Environments (LIVE) platform (requires Windows)
  • have broadband Internet connection,
  • achieve a Galveston Orientation Assessment Test (GOAT) score >75 to ensure appropriate levels of cognition for the study
  • and score >93.8 on the Western Battery Aphasia-Revised (WAB-R) scale to indicate sufficient communicative abilities to participate in a social support group and exit interview group.
  • able to understand and independently consent for the study and provide written consent prior to enrollment in the study

Exclusion Criteria:

- verbal communication impairments will be excluded as measured by the WAB-R, as this study intends to focus on persons with social communication deficits rather than verbal deficits.

Sites / Locations

  • The University of Texas Health Science Center at Houston
  • TIRR Memorial Hermann

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Envrionment for Social Communication

Arm Description

Once the intervention begins, participants will meet online from home for one-hour sessions twice a week (twelve sessions over six weeks). Weekly sessions will follow a standardized format: 15 minutes- Social support group (guided discussion of experiences related to weekly topic) 20 minutes- Didactic instruction 15 minutes- Role playing 10 minutes- Debriefing and group feedback

Outcomes

Primary Outcome Measures

Perceived Usability as Assessed by the System Usability Scale (SUS)
Scores on the System Usability Scale (SUS) range from 0-100, with higher scores indicating greater usability (which is the desired outcome).
Acceptability as Assessed by the Acceptability E-Scale
Scores on the Acceptability E-scale range from 6-30, with higher scores indicating greater acceptability (which is the desired outcome).
Feasibility as Assessed by Participation Rate
Scores on the LaTrobe Social Communication Questionnaire (LCQ) range from 30-120, with lower score indicating less social communication impairment (which is the desired outcome).
Feasibility as Assessed by Attrition Rate

Secondary Outcome Measures

Change in Social Communication as Assessed by the LaTrobe Communication Questionnaire (LCQ)

Full Information

First Posted
June 27, 2018
Last Updated
April 12, 2019
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
The Institute for Rehabilitaion and Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03582228
Brief Title
Bridging Recovery Allies in Virtual Environments
Acronym
BRAVE
Official Title
Bridging Recovery Allies in Virtual Environments (BRAVE)-Understanding Feasibility and Acceptability of Using Virtual Environments for Social Communication in Persons With TBI
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
The Institute for Rehabilitaion and Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Bridging Recovery Allies in Virtual Environments (BRAVE) study aims to evaluate the acceptability and feasibility of implementing a virtual environment (VE) social support group for social communication training among adults with traumatic brain injury (TBI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Virtual Environments, Social Communication

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Envrionment for Social Communication
Arm Type
Experimental
Arm Description
Once the intervention begins, participants will meet online from home for one-hour sessions twice a week (twelve sessions over six weeks). Weekly sessions will follow a standardized format: 15 minutes- Social support group (guided discussion of experiences related to weekly topic) 20 minutes- Didactic instruction 15 minutes- Role playing 10 minutes- Debriefing and group feedback
Intervention Type
Behavioral
Intervention Name(s)
Virtual Envrionment for Social Communication
Intervention Description
Once the Virtual Envrionment for Social Communication intervention begins, participants will meet online from home for one-hour sessions twice a week (twelve sessions over six weeks). Weekly sessions will follow a standardized format: 15 minutes- Social support group (guided discussion of experiences related to weekly topic) 20 minutes- Didactic instruction 15 minutes- Role playing 10 minutes- Debriefing and group feedback
Primary Outcome Measure Information:
Title
Perceived Usability as Assessed by the System Usability Scale (SUS)
Description
Scores on the System Usability Scale (SUS) range from 0-100, with higher scores indicating greater usability (which is the desired outcome).
Time Frame
about 1 week after the end of the intervention
Title
Acceptability as Assessed by the Acceptability E-Scale
Description
Scores on the Acceptability E-scale range from 6-30, with higher scores indicating greater acceptability (which is the desired outcome).
Time Frame
about 1 week after the end of the intervention
Title
Feasibility as Assessed by Participation Rate
Description
Scores on the LaTrobe Social Communication Questionnaire (LCQ) range from 30-120, with lower score indicating less social communication impairment (which is the desired outcome).
Time Frame
from the start of the intervention to the end of the intervention (6 weeks)
Title
Feasibility as Assessed by Attrition Rate
Time Frame
from the start of the intervention to the end of the intervention (6 weeks)
Secondary Outcome Measure Information:
Title
Change in Social Communication as Assessed by the LaTrobe Communication Questionnaire (LCQ)
Time Frame
baseline, about 1 week after the end of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects with a traumatic brain injury between the age of 18 and 80 living in the community able to read and speak English, are more than 1-year post-injury are accessible by phone, report independent computer usage over the last 6 months have access to a computer meeting minimum specifications for the Learning in Virtual Environments (LIVE) platform (requires Windows) have broadband Internet connection, achieve a Galveston Orientation Assessment Test (GOAT) score >75 to ensure appropriate levels of cognition for the study and score >93.8 on the Western Battery Aphasia-Revised (WAB-R) scale to indicate sufficient communicative abilities to participate in a social support group and exit interview group. able to understand and independently consent for the study and provide written consent prior to enrollment in the study Exclusion Criteria: - verbal communication impairments will be excluded as measured by the WAB-R, as this study intends to focus on persons with social communication deficits rather than verbal deficits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilary N Touchett, PhD(c)
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77584
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bridging Recovery Allies in Virtual Environments

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