Clinical trial NCT03582228: Bridging Recovery Allies in Virtual Environments
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
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Virtual Environments
Social Communication
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: The Institute for Rehabilitaion and Research Foundation
First posted: 2018-07-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


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.

Primary outcomes:
measure: Perceived Usability as Assessed by the System Usability Scale (SUS)
timeFrame: about 1 week after the end of the intervention
measure: Acceptability as Assessed by the Acceptability E-Scale
timeFrame: about 1 week after the end of the intervention
measure: Feasibility as Assessed by Participation Rate
timeFrame: from the start of the intervention to the end of the intervention (6 weeks)
measure: Feasibility as Assessed by Attrition Rate
timeFrame: from the start of the intervention to the end of the intervention (6 weeks)
Secondary outcomes:
measure: Change in Social Communication as Assessed by the LaTrobe Communication Questionnaire (LCQ)
timeFrame: baseline, about 1 week after the end of the intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Hilary N Touchett, PhD(c)
role: PRINCIPAL_INVESTIGATOR
References: