N/A
N=31
Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families
Brain Injuries, Traumatic · Transitional Care · Family Members · Patients
Bottom Line
View on ClinicalTrials.gov: NCT04584554 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Change in Quality of Life as Measured by the Short Form-36 (SF-36) — 47.97 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BETTER Transitional Care Intervention (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life as Measured by the Short Form-36 (SF-36) |
47.97 | — |
| SECONDARY Change in Preparedness for Caregiving Scale (CPS) |
25.75 | — |
Summary
Despite high risks of readmission and complex medical needs, there are no transitional care standards in the U.S. for patients with moderate-to-severe traumatic brain injury (TBI) discharged home from acute hospital care without inpatient rehabilitation. To enhance the standard of TBI care, we will develop and refine a patient- and family-centered TBI transitional care intervention that addresses specific needs and preferences for patients with TBI (age < 65 years) and families and will assess the feasibility, acceptability, and preliminary efficacy of the intervention.
Eligibility Criteria
Inclusion Criteria
- Patients: age 18-64 years, diagnosis of mild-moderate TBI based on Glasgow Coma Scale score of 9-14; sufficient cognitive functioning and oral communication skills to participate (as determined by Galveston Orientation and Amnesia Test); set to be discharged directly home from acute hospital care; and has smart phone or computer with internet access.
- Family caregiver: age 18 years or older, primary caregiver for patient post-discharge (i.e., plans to live in same home as person or have direct contact with person >10 hours/week); and has smart phone or computer with internet access.
Exclusion Criteria
- Patients: who do not have a family caregiver who is willing to participate; prior neurological disorder affecting the brain or language or learning disability
Data sourced from ClinicalTrials.gov (NCT04584554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.