Improving Traumatic Brain Injury Rehab Care With Comm Health Services: a Research Project Within the TBI Model System

NCT06188364 | Recruiting Early Phase 1

• 1 other identifier: HM20027800
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Keywords

Community Health Services; Rehabilitation Care Transitions; Caregiver Supports

Outcome Measures

Primary Outcomes (1)

• 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 at 12-weeks post-discharge

Secondary Outcomes (2)

• Caregiver Well-Being Scale - Short Form (CWBS-SF) - Care Partner Well-Bing

  Measured at 24-weeks post-discharge

• Patient Health Questionnaire - 4 (PHQ-4) - Care Partner Emotional Distress

  Measured at 12- and 24-weeks post-discharge.

Study Arms (2)

Standard of Care

OTHER

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

Other: Standard of Care

Experimental

EXPERIMENTAL

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

Other: Experimental

Interventions

Standard of Care OTHER

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

Standard of Care

Experimental OTHER

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Department of Health and Human Services: collaborator
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Daniel Klyce

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Abbasi

CONTACT

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

Ronald Seel

CONTACT

ronald.seel@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: April 26, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

US (1)