Traumatic Brain InjuryEarly Phase 1NCT06188364
Improving Traumatic Brain Injury Rehab Care With Comm Health Services: a Research Project Within the TBI Model System
A Early Phase 1 study testing Experimental in people with Traumatic Brain Injury, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
TBI rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2024to 31 Aug 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants must be adults (age 18 or older).
- Must be primary person responsible for supervision/care needs of person with TBI post-IRF discharge.
- The person with TBI must have been admitted to the Brain Injury Service Unit at SAI.
- If the care partner does not live in the same residence as the person with TBI, they must provide multiple daily check-ins on day-to-day care.
- Must agree to use mHealth (texts, calls) and possess or be eligible to acquire a smart phone.
Who cannot join
- Any severe cognitive impairment that precludes the ability to provide informed consent or safely function as the care partner for a vulnerable adult with TBI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ronald Seel contact
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Katherine Abbasi, 804-828-3703, katherine.walker@vcuhealth.org
Daniel Klyce, daniel.klyce@vcuhealth.org
About this study
Official title: Improving Traumatic Brain Injury Rehabilitation Care Transitions With Community Health Services: A Randomized Clinical Trial (CHW Intervention for TBI Care Transitions [CHWI for TBI]), a Research Project Within the TBI Model System
TBI rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. Persons with TBI have heterogenous neurological impairment (cognitive and behavioral foremost, along with motor, sensory, and balance), that limits their functional independence and participation, and increases their risk for secondary medical conditions, injuries, rehospitalizations and early mortality
Read the detailed description
Once people with TBI and their care partners enter the post-acute care landscape, they must navigate fragmented health care systems, interact with providers who may be unfamiliar with TBI, and discover their own services and supports. Inpatient rehabilitation provides high levels of structure and professional support that are impossible to replicate when constructing a home environment to independently manage day-to-day care. Once home, the person with TBI's physical, cognitive, behavioral, and medical needs can easily overwhelm even the most committed care partners. Community health workers (CHWs) through a combination of care coordination, advocacy, and direct service delivery, have the potential to address TBI care partners' needs, particularly those from low income and/or traditionally underserved minority groups. CHWs are well-suited to fill resource gaps that TBI care partners have difficulty finding, including: (1) finding diagnostic, treatment, and social services; (2) assisting with referrals; (3) providing health education and motivational interviewing to support behavioral health change; (4) collecting and managing clinical data; (5) facilitating productive relationships between health services and communities, and (6) offering psychosocial support.
- Conditions
- Traumatic Brain Injury
- Being tested
- Standard of Care, Experimental
- Keywords
- Community Health Services, Rehabilitation Care Transitions, Caregiver Supports
- 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.
Standard of CareOther
The usual Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge, so the the delivery of traditional CHW outreach services such as finding health, community and social determinants referrals, problem-solving, and connecting care partners to long-term supports/services
ExperimentalOther
Novel aspects of the CHW experimental intervention for TBI care partners include:
- CHW services begin prior to inpatient rehabilitation discharge;
- care partners get timely, useful health management materials;
- encounters focus on unlimited, brief, situation-focused calls to help care partners assess and resolve pressing concerns; and
- long-term support capacity for care partners is built by establishing a reliable referral network of medical, community, and social services that become foundational resources beyond study completion.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge Receives: Other: Standard of Care |
| Experimental | Experimental | USS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Managing Your loved Ones Health - Care Partner Activation
Based on 32 self-report items prompt care partners to rate agreement with caregiving activity and engagement statements. Rated "1-Completely Agree" to "4-Completely Disagree" or "0 - Not My Responsibility."
Used because:
Good full-scale reliability (α=0.95). Sufficiently unidimensional for Rasch modeling with acceptable fit statistics, low standard error of measurement, and good range of item difficulty (23.8 - 71.8).
Good concurrent validity: (a) positive correlations w/ care partner preparedness, self-competence, and self-confidence, and (b) negative correlations with stress, anxiety, and poor mental health
Measured: Measured at 12-weeks post-discharge
Secondary outcomes (2)
Caregiver Well-Being Scale - Short Form (CWBS-SF) - Care Partner Well-Bing
Based on 16 self-report items prompt care partners to rate representativeness of basic needs met and keeping up with day-to-day activities Rated from "1 - Rarely" to "5 - Usually."
Used Because:
Good full-scale reliability (α=0.83). Items have low redundancy; average inter-item r=.25 (range: .01 - .49). Good fit with two-factor model: (1) Basic Needs and (2) Implementation of Met Needs.
Measured: Measured at 24-weeks post-discharge
Patient Health Questionnaire - 4 (PHQ-4) - Care Partner Emotional Distress
Based on 4 self-report items prompt respondents to rate their depression and anxiety over last two weeks. Rated from "0 - Not at All" to "3 - Nearly Every Day."
Used because:
Good full-scale reliability (α=0.85). Clear 2-factor structure (anxiety and depression) explaining 84% of variance. High sensitivity as a screening scale.
Measured: Measured at 12- and 24-weeks post-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start26 Apr 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (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 Virginia Commonwealth UniversityThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a single center, randomized clinical trial (RCT). We will use a block-randomization design with two arms: 1. Usual Care Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge and 2. Experimental USS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners: 1. beginning within one week of inpatient rehabilitation discharge, 2. active services (initiated by CHW or Care Partner) extending over 1- 12 weeks post-discharge, and 3. passive services (initiated by care partner request only) 13-24 weeks post-discharge.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Daniel Klyce, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188364
- Sponsor's protocol ID
- HM20027800
- Status last verified
- May 2026
- First submitted
- 18 Dec 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Traumatic Brain Injury Rehabilitation Care Transitions With Community Health Services: A Randomized Clinical Trial (CHW Intervention for TBI Care Transitions [CHWI for TBI]), a Research Project Within the TBI Model System
- ClinicalTrials.gov ID
- NCT06188364
- Acronym / sponsor ID
- HM20027800
- Conditions
- Traumatic Brain Injury
- Keywords
- Community Health Services, Rehabilitation Care Transitions, Caregiver Supports
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 3 Jan 2024 (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.
TBI rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. Persons with TBI have heterogenous neurological impairment (cognitive and behavioral foremost, along with motor, sensory, and balance), that limits their functional independence and participation, and increases their risk for secondary medical conditions, injuries, rehospitalizations and early mortality
Detailed description
Once people with TBI and their care partners enter the post-acute care landscape, they must navigate fragmented health care systems, interact with providers who may be unfamiliar with TBI, and discover their own services and supports. Inpatient rehabilitation provides high levels of structure and professional support that are impossible to replicate when constructing a home environment to independently manage day-to-day care. Once home, the person with TBI's physical, cognitive, behavioral, and medical needs can easily overwhelm even the most committed care partners. Community health workers (CHWs) through a combination of care coordination, advocacy, and direct service delivery, have the potential to address TBI care partners' needs, particularly those from low income and/or traditionally underserved minority groups. CHWs are well-suited to fill resource gaps that TBI care partners have difficulty finding, including: (1) finding diagnostic, treatment, and social services; (2) assisting with referrals; (3) providing health education and motivational interviewing to support behavioral health change; (4) collecting and managing clinical data; (5) facilitating productive relationships between health services and communities, and (6) offering psychosocial support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a single center, randomized clinical trial (RCT). We will use a block-randomization design with two arms: 1. Usual Care Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge and 2. Experimental USS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners: 1. beginning within one week of inpatient rehabilitation discharge, 2. active services (initiated by CHW or Care Partner) extending over 1- 12 weeks post-discharge, and 3. passive services (initiated by care partner request only) 13-24 weeks post-discharge.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Other: Standard of CareTransition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge |
| Experimental | Experimental | Other: ExperimentalUSS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be adults (age 18 or older).
- Must be primary person responsible for supervision/care needs of person with TBI post-IRF discharge.
- The person with TBI must have been admitted to the Brain Injury Service Unit at SAI.
- If the care partner does not live in the same residence as the person with TBI, they must provide multiple daily check-ins on day-to-day care.
- Must agree to use mHealth (texts, calls) and possess or be eligible to acquire a smart phone.
Key exclusion criteria (1 listed)
- Any severe cognitive impairment that precludes the ability to provide informed consent or safely function as the care partner for a vulnerable adult with 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 |
|---|---|---|
| Standard of CareThe usual Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge, so the the delivery of traditional CHW outreach services such as finding health, community and social determinants referrals, problem-solving, and connecting care partners to long-term supports/services | Other | Standard of Care |
| ExperimentalNovel aspects of the CHW experimental intervention for TBI care partners include: 1. CHW services begin prior to inpatient rehabilitation discharge; 2. care partners get timely, useful health management materials; 3. encounters focus on unlimited, brief, situation-focused calls to help care partners assess and resolve pressing concerns; and 4. long-term support capacity for care partners is built by establishing a reliable referral network of medical, community, and social services that become foundational resources beyond study completion. | Other | Experimental |
Primary outcome
Managing Your loved Ones Health - Care Partner Activation
Time frame: Measured at 12-weeks post-discharge
Based on 32 self-report items prompt care partners to rate agreement with caregiving activity and engagement statements. Rated "1-Completely Agree" to "4-Completely Disagree" or "0 - Not My Responsibility." Used because: Good full-scale reliability (α=0.95). Sufficiently unidimensional for Rasch modeling with acceptable fit statistics, low standard error of measurement, and good range of item difficulty (23.8 - 71.8). Good concurrent validity: (a) positive correlations w/ care partner preparedness, self-competence, and self-confidence, and (b) negative correlations with stress, anxiety, and poor mental health
2 secondary outcomes
Caregiver Well-Being Scale - Short Form (CWBS-SF) - Care Partner Well-Bing
Time frame: Measured at 24-weeks post-discharge
Patient Health Questionnaire - 4 (PHQ-4) - Care Partner Emotional Distress
Time frame: Measured at 12- and 24-weeks post-discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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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.
Ronald Seel contact
Daniel Klyce principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Experimental in people with Traumatic Brain Injury, run by Virginia Commonwealth University 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 5 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Abbasi (804-828-3703, katherine.walker@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Managing Your loved Ones Health - Care Partner Activation (time frame: Measured at 12-weeks post-discharge). 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 14 May 2026.