Bridging Recovery Allies in Virtual Environments (BRAVE)

Bridging Recovery Allies in Virtual Environments (BRAVE)-Understanding Feasibility and Acceptability of Using Virtual Environments for Social Communication in Persons With TBI

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).

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Virtual Envrionment for Social Communication

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77584
      • TIRR Memorial Hermann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Envrionment for Social Communication; 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
Feasibility as Assessed by Attrition Rate		from the start of the intervention to the end of the intervention (6 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Social Communication as Assessed by the LaTrobe Communication Questionnaire (LCQ)	baseline, about 1 week after the end of the intervention

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: The Institute for Rehabilitaion and Research Foundation
• Investigators: Principal Investigator: Hilary N Touchett, PhD(c), The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Social Communication; Virtual Environments
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: HSC-SN-18-0491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No