A Culturally Sensitive Intervention for TBI Caregivers in Latin America

Traumatic Brain Injury Clinical Trial

Official title:

A Culturally Sensitive Intervention for TBI Caregivers in Latin America

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207803
• Other study ID #: HM20001660
• Secondary ID: R21TW009746
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: September 19, 2017
• Start date: January 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: September 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Behavioral:
• Transition Assistance Program

Locations

Country	Name	City	State
Colombia	Pontificia Universidad Javeriana Cali	Cali
Colombia	Universidad Sur Colombiana	Neiva
Mexico	National Institute of Neurology and Neurosurgery	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	John E. Fogarty International Center (FIC)

Countries where clinical trial is conducted

Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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