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

Early Phase 1
Recruiting
Conditions
Traumatic Brain Injury
Interventions
Other: Experimental
Other: Standard of Care
Registration Number
NCT06188364
Lead Sponsor
Virginia Commonwealth University
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

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
126
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ExperimentalExperimentalUSS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners
Standard of CareStandard of CareTransition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge
Primary Outcome Measures
NameTimeMethod
Managing Your loved Ones Health - Care Partner ActivationMeasured 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

Secondary Outcome Measures
NameTimeMethod
Patient Health Questionnaire - 4 (PHQ-4) - Care Partner Emotional DistressMeasured at 12- and 24-weeks post-discharge.

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.

Caregiver Well-Being Scale - Short Form (CWBS-SF) - Care Partner Well-BingMeasured at 24-weeks post-discharge

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.

Trial Locations

Locations (1)

Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

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