NCT06188364 · Virginia Commonwealth University
Improving Traumatic Brain Injury Rehab Care With Comm Health Services: a Research Project Within the TBI Model System
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Standard of Care
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
OTHER
Experimental
Novel 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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Richmond, Virginia
Collaborators
Department of Health and Human Services, National Institute on Disability, Independent Living, and Rehabilitation Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations