N/A
N=250
A Culturally Sensitive Intervention for TBI Caregivers in Latin America
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT02207803 ↗Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Zarit Burden Interview — 23.41; 26.48 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transition Assistance Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Zarit Burden Interview |
23.41; 26.48 | — |
| SECONDARY Exemplary Care Scale-Provide Subscale |
14.23; 14.07 | — |
Summary
Traumatic brain injury (TBI) patients in Latin America experience high levels of disability and extremely poor functional outcomes, and their informal caregivers play a key role in their rehabilitation and care. To improve TBI rehabilitation through stronger informal caregiving, the proposed study will develop and evaluate an evidence--based and culturally sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin America during the patient's transition from hospital to home. This study will generate findings that can provide empirically supported guidance to clinicians regarding the provision of culturally tailored rehabilitation services for TBI caregivers in Latin America and in the U.S.
Eligibility Criteria
TBI Patient Inclusion Criteria:
- Will be discharged home and not to a nursing home
- Give permission for their caregiver to participate
- Sign an informed consent
- Have the ability to communicate over the phone for data collection
- Are between 18-60 years of age
Caregiver Inclusion Criteria
- Have a telephone in the home or cellular phone and are able to talk on the phone
- Sign an informed consent
- Score at least a 13 on a health literacy screening tool
- Are between 18-85 years of age
Data sourced from ClinicalTrials.gov (NCT02207803). 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.