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A Culturally Sensitive Intervention for TBI Caregivers in Latin America

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Behavioral: Transition Assistance Program

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02207803
R21TW009746 (U.S. NIH Grant/Contract)
HM20001660

Details and patient eligibility

About

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.

Enrollment

250 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

250 participants in 2 patient groups

Intervention
Experimental group
Description:
Experimental Transition Assistance Program
Treatment:
Behavioral: Transition Assistance Program
Control
No Intervention group
Description:
Control

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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