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Clinical Trials/NCT06188364
NCT06188364
Recruiting
Early Phase 1

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

Virginia Commonwealth University1 site in 1 country126 target enrollmentApril 26, 2024

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Virginia Commonwealth University
Enrollment
126
Locations
1
Primary Endpoint
Managing Your loved Ones Health - Care Partner Activation
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 26, 2024
End Date
August 31, 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Patient Health Questionnaire - 4 (PHQ-4) - Care Partner Emotional Distress(Measured at 12- and 24-weeks post-discharge.)
  • Caregiver Well-Being Scale - Short Form (CWBS-SF) - Care Partner Well-Bing(Measured at 24-weeks post-discharge)

Study Sites (1)

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