Traumatic Brain InjuryBRAVENCT03582228
Bridging Recovery Allies in Virtual Environments
A study testing Virtual Envrionment for Social Communication in people with Traumatic Brain Injury, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Virtual Envrionment for Social Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Aug 2018to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
TIRR Memorial Hermann
Houston, Texas, 77584
About this study
Official title: 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).
- Conditions
- Traumatic Brain Injury
- Being tested
- Virtual Envrionment for Social Communication
- Keywords
- Virtual Environments, Social Communication
- Medical subject headings
- Brain Injuries, Traumatic, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Envrionment for Social CommunicationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Virtual Envrionment for Social Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: from the start of the intervention to the end of the intervention (6 weeks)
Feasibility as Assessed by Attrition Rate
Measured: 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)
Measured: baseline, about 1 week after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start6 Aug 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute for Rehabilitaion and Research Foundation
- Responsible party
- Principal investigator, Hilary Nicole Touchett, The University of Texas Health Science Center, Houston
- Investigators
- Hilary N Touchett, PhD(c), Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582228
- Sponsor's protocol ID
- HSC-SN-18-0491
- Acronym
- BRAVE
- Status last verified
- Apr 2019
- First submitted
- 27 Jun 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Recovery Allies in Virtual Environments (BRAVE)-Understanding Feasibility and Acceptability of Using Virtual Environments for Social Communication in Persons With TBI
- ClinicalTrials.gov ID
- NCT03582228
- Acronym / sponsor ID
- BRAVE / HSC-SN-18-0491
- Conditions
- Traumatic Brain Injury
- Keywords
- Virtual Environments, Social Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The Institute for Rehabilitaion and Research Foundation
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Envrionment for Social Communication | Experimental | Behavioral: Virtual Envrionment for Social CommunicationOnce 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Envrionment for Social CommunicationOnce 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 | Behavioural | Virtual Envrionment for Social Communication |
Primary outcome
Perceived Usability as Assessed by the System Usability Scale (SUS)
Time frame: about 1 week after the end of the intervention
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
Time frame: about 1 week after the end of the intervention
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
Time frame: from the start of the intervention to the end of the intervention (6 weeks)
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
Time frame: from the start of the intervention to the end of the intervention (6 weeks)
1 secondary outcome
Change in Social Communication as Assessed by the LaTrobe Communication Questionnaire (LCQ)
Time frame: baseline, about 1 week after the end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Not yet recruitingObservational study
Description of Clinicians' Predictive Abilities Before and After a Diffusion Tensor Imaging (DTI)
Diffusion Tensor Imaging Prognosis, Brain Injury, Traumatic
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilary N Touchett, PhD(c) principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Envrionment for Social Communication in people with Traumatic Brain Injury, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Usability as Assessed by the System Usability Scale (SUS) (time frame: about 1 week after the end of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.