Bridging Recovery Allies in Virtual Environments

Traumatic Brain Injury Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582228
• Other study ID #: HSC-SN-18-0491
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: April 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Behavioral:
• Virtual Envrionment for Social Communication
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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	TIRR Memorial Hermann	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	The Institute for Rehabilitaion and Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	about 1 week after the end of the intervention
Primary	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).	about 1 week after the end of the intervention
Primary	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).	from the start of the intervention to the end of the intervention (6 weeks)
Primary	Feasibility as Assessed by Attrition Rate		from the start of the intervention to the end of the intervention (6 weeks)
Secondary	Change in Social Communication as Assessed by the LaTrobe Communication Questionnaire (LCQ)		baseline, about 1 week after the end of the intervention