Traumatic Brain InjuryREACH TBINCT06111794
The REACH Intervention for Caregivers of Veterans and Service Members With TBI
A study testing REACH TBI in people with Traumatic Brain Injury and Caregiver, run by University of Virginia at 1 site in United States.
Trial summary
This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Caregiver
- What is being tested?
- REACH TBI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2024to Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for the study, the participant must:
- identify as a primary caregiver for a V/SM who sustained a TBI at least 6 months prior;
- identify as a primary caregiver who has provided care for a V/SM with TBI for at least 6 months;
- provide some level of daily supervision or assistance with either a physical, cognitive, or behavioral issue they think is likely related to TBI;
- believe that at least half of their caregiving responsibilities are likely related to TBI rather than another health condition(s); and
- endorse a score of at least high burden (a score of 8 or higher) on the Zarit Burden Inventory-4.
Who cannot join
- no telephone;
- current diagnosis of schizophrenia or other major mental illness;
- auditory impairment that would make telephone use difficult; or
- the caregiver believes that more than half of their caregiving for the V/SM is for issues related to another health condition(s) rather than TBI.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tampa VA Medical Center
Tampa, Florida, 33612
Risa Nakase-Richardson, PhD
About this study
Official title: The REACH Intervention for Caregivers of Veterans and Service Members With TBI: Efficacy and Implementation Planning Across the VA Polytrauma System of Care
This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care frustrations (secondary outcomes). This study will modify and adapt an award-winning caregiver intervention, Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA), to support the needs of Caregivers of Veterans and Service Members with TBI.
- Conditions
- Traumatic Brain Injury, Caregiver
- Being tested
- REACH TBI
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACH TBIOther
Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) is a six-session, telephone intervention for Caregivers of Veterans and Services Members with TBI. The intervention focuses on problem solving training, stress management, and psychoeducation. Trained Program Coaches will deliver the REACH TBI intervention by meeting one-on-one via telephone with participants.
| Study group | Role | What they receive |
|---|---|---|
| REACH TBI | Experimental | Participants will receive the REACH TBI psychoeducational intervention. Receives: Other: REACH TBI |
| Waitlist Control | Active comparator | Participants will receive the REACH TBI psychoeducational intervention. Receives: Other: REACH TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBI-CareQOL Caregiver Strain - Short Form 6a
It assesses caregiver strain in caregivers of individuals with TBI. Values range from 6-30, with higher scores indicating greater strain/worse outcome.
Measured: Baseline; 3 months (post-intervention); 6 month follow-up
Secondary outcomes (4)
Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a
It assesses caregiver depression. Values range from 8-40, with higher scores indicating greater depression/worse outcome.
Measured: Baseline; 3 months (post-intervention); 6 month follow-up
Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a
It assesses caregiver anxiety. Values range from 7-35, with higher scores indicating greater anxiety/worse outcome.
Measured: Baseline; 3 months (post-intervention); 6 month follow-up
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy
It assesses caregiver self-efficacy. Values from range 10-50, with higher scores indicating greater self-efficacy/better outcome.
Measured: Baseline; 3 months (post-intervention); 6 month follow-up
TBI-CareQOL Health Care Frustration - Self - Short Form 6a
It assesses frustrations a TBI caregiver has had with health care services. Values range from 6-30, with higher scores indicating greater frustration with services received/worse outcome.
Measured: Baseline; 3 months (post-intervention); 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start12 Jul 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
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.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a treatment/waitlist-control crossover repeated-measures design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- James A. Haley Veterans Administration Hospital, Virginia Commonwealth University, University of Utah, University of Tennessee
- Responsible party
- Principal investigator, Paul B. Perrin, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111794
- Sponsor's protocol ID
- CDMRP-TP220091
- Acronym
- REACH TBI
- Status last verified
- Aug 2024
- First submitted
- 26 Oct 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data are available to other researchers via FITBIR.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The REACH Intervention for Caregivers of Veterans and Service Members With TBI: Efficacy and Implementation Planning Across the VA Polytrauma System of Care
- ClinicalTrials.gov ID
- NCT06111794
- Acronym / sponsor ID
- REACH TBI / CDMRP-TP220091
- Conditions
- Traumatic Brain Injury, Caregiver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- James A. Haley Veterans Administration Hospital, Virginia Commonwealth University, University of Utah, University of Tennessee
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 Nov 2023 (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.
This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care frustrations (secondary outcomes). This study will modify and adapt an award-winning caregiver intervention, Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA), to support the needs of Caregivers of Veterans and Service Members with TBI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a treatment/waitlist-control crossover repeated-measures design.
| Arm | Type | Receives |
|---|---|---|
| REACH TBI | Experimental | Other: REACH TBIParticipants will receive the REACH TBI psychoeducational intervention. |
| Waitlist Control | Active comparator | Other: REACH TBIParticipants will receive the REACH TBI psychoeducational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- identify as a primary caregiver for a V/SM who sustained a TBI at least 6 months prior;
- identify as a primary caregiver who has provided care for a V/SM with TBI for at least 6 months;
- provide some level of daily supervision or assistance with either a physical, cognitive, or behavioral issue they think is likely related to TBI;
- believe that at least half of their caregiving responsibilities are likely related to TBI rather than another health condition(s); and
- endorse a score of at least high burden (a score of 8 or higher) on the Zarit Burden Inventory-4.
Key exclusion criteria (4 listed)
- no telephone;
- current diagnosis of schizophrenia or other major mental illness;
- auditory impairment that would make telephone use difficult; or
- the caregiver believes that more than half of their caregiving for the V/SM is for issues related to another health condition(s) rather than TBI.
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 |
|---|---|---|
| REACH TBIResources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) is a six-session, telephone intervention for Caregivers of Veterans and Services Members with TBI. The intervention focuses on problem solving training, stress management, and psychoeducation. Trained Program Coaches will deliver the REACH TBI intervention by meeting one-on-one via telephone with participants. | Other | REACH TBI, Waitlist Control |
Primary outcome
TBI-CareQOL Caregiver Strain - Short Form 6a
Time frame: Baseline; 3 months (post-intervention); 6 month follow-up
It assesses caregiver strain in caregivers of individuals with TBI. Values range from 6-30, with higher scores indicating greater strain/worse outcome.
4 secondary outcomes
Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a
Time frame: Baseline; 3 months (post-intervention); 6 month follow-up
Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a
Time frame: Baseline; 3 months (post-intervention); 6 month follow-up
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy
Time frame: Baseline; 3 months (post-intervention); 6 month follow-up
TBI-CareQOL Health Care Frustration - Self - Short Form 6a
Time frame: Baseline; 3 months (post-intervention); 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. De-identified individual participant data are available to other researchers via FITBIR.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REACH TBI in people with Traumatic Brain Injury and Caregiver, run by University of Virginia at 1 site 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul B Perrin, PhD ((434) 982-2600, perrin@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TBI-CareQOL Caregiver Strain - Short Form 6a (time frame: Baseline; 3 months (post-intervention); 6 month follow-up). 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 9 Aug 2024.