A Culturally Sensitive Intervention for TBI Caregivers in Latin America

Study Overview
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Brief Summary
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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.

Official Title
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A Culturally Sensitive Intervention for TBI Caregivers in Latin America

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Transition Assistance Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Experimental Transition Assistance Program | Behavioral: Transition Assistance Program<br> <br> |
| No Intervention: Control<br>Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months post-hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months post-hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Injuries, Caregivers, Intervention Studies, Latin America