Bridging Recovery Allies in Virtual Environments

NCT03582228 | Completed

• 1 other identifier: HSC-SN-18-0491
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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).

Conditions

Traumatic Brain Injury

Keywords

Virtual Environments; Social Communication

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

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

  baseline, about 1 week after the end of the intervention

Study Arms (1)

Virtual Envrionment for Social Communication

EXPERIMENTAL

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

Interventions

Virtual Envrionment for Social Communication BEHAVIORAL

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

Virtual Envrionment for Social Communication

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• The Institute for Rehabilitaion and Research Foundation: collaborator
• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77584, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Communication

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Hilary N Touchett, PhD(c)

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student, Robert Wood Johnson Foundation Future of Nursing Scholar

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 10, 2018
• Study Start: August 6, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)