Recruiting
Early Phase 1

Observational Study

Sponsor:

Virginia Commonwealth University

Code:

NCT06188364

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care

Experimental

Study Details

Brief 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. 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

Conditions

Traumatic Brain Injury

Study ID

NCT06188364

Start date

Apr 26, 2024

Status verified date

May, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Standard of Care

Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge

experimental: Experimental

USS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners

Interventions

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

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 measure

  • Managing Your loved Ones Health - Care Partner Activation [ Time Frame: Measured at 12-weeks post-discharge ]

Central Contacts and Locations

Central contacts

Katherine Abbasi

804-828-3703katherine.walker@vcuhealth.org

Ronald Seel

ronald.seel@vcuhealth.org

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Katherine Abbasi

804-828-3703katherine.walker@vcuhealth.org

Daniel Klyce

daniel.klyce@vcuhealth.org

More Information

Sponsor

Virginia Commonwealth University

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Community Health Services
  • Rehabilitation Care Transitions
  • Caregiver Supports

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-05-14.