Multi-site, multi-country randomized clinical trial of an acute traumatic brain injury caregiver transition assistance program in Latin America.

BACKGROUND Individuals with traumatic brain injury (TBI) 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. OBJECTIVE To improve TBI rehabilitation through stronger informal caregiving, this study developed and evaluated an evidence-based and culturally appropriate Transition Assistance Program (TAP) for informal caregivers of individuals with TBI in Latin America, specifically targeting the time period before and after the transition from hospital to home. METHODS A sample of 89 people with a new TBI and their primary informal caregiver (n = 178) was recruited from two hospitals in Mexico City, Mexico, and in Cali, Colombia. Caregivers were randomly assigned to either the TAP group or to a control group receiving the standard care provided by the hospital. Caregivers completed measures of depression and burden, and individuals with TBI completed measures of depression and self-perceived burden on caregivers before hospital discharge and at 2- and 4-month follow ups. RESULTS Caregivers in the TAP group reported significantly lower burden than those in the control group and marginally lower depression. Individuals with TBI whose caregivers had been in the TAP group reported significantly lower depression than those whose caregivers had been in the control group and non-significant but lower self-perceived burden on their caregivers. CONCLUSION The results suggest that the TAP has strong potential to benefit both TBI caregivers and individuals with TBI during the transition from acute TBI hospitalization to home in Latin America, generally showing small-or medium-sized effects on key outcomes.