A Culturally Sensitive Intervention for TBI Caregivers in Latin America

N/ACompletedNCT02207803

Virginia Commonwealth University250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

250

Conditions

Traumatic Brain Injury

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (3)

Pontificia Universidad Javeriana Cali

Cali, Colombia

Universidad Sur Colombiana

Neiva, Colombia

National Institute of Neurology and Neurosurgery

Mexico City, Mexico

Outcomes

Primary Outcomes

Zarit Burden Interview

22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.

Time frame: 2 months post-hospital discharge

Secondary Outcomes

Exemplary Care Scale-Provide Subscale

4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here.

Time frame: 2 months post-hospital discharge