A Culturally Sensitive Intervention for TBI Caregivers in Latin America

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: Transition Assistance Program

• Registration Number: NCT02207803
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-04
• Study Start: 2015-01
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Results First Submitted: 2017-06-02
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-19
• Last Update Submitted: 2017-09-19
• Results First Posted: 2017-10-18
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Transition Assistance Program	Experimental Transition Assistance Program

Primary Outcome Measures

Name	Time	Method
Zarit Burden Interview	2 months post-hospital discharge	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.

Secondary Outcome Measures

Name	Time	Method
Exemplary Care Scale-Provide Subscale	2 months post-hospital discharge	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.

Trial Locations

Locations (3)

Pontificia Universidad Javeriana Cali; 🇨🇴 Cali, Colombia

Universidad Sur Colombiana; 🇨🇴 Neiva, Colombia

National Institute of Neurology and Neurosurgery; 🇲🇽 Mexico City, Mexico