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A Culturally Sensitive Intervention for TBI Caregivers in Latin America

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transition Assistance Program
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Traumatic Brain Injury focused on measuring Brain Injuries, Caregivers, Intervention Studies, Latin America

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pontificia Universidad Javeriana Cali
  • Universidad Sur Colombiana
  • National Institute of Neurology and Neurosurgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Experimental Transition Assistance Program

Control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 31, 2014
Last Updated
September 19, 2017
Sponsor
Virginia Commonwealth University
Collaborators
Fogarty International Center of the National Institute of Health
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1. Study Identification

Unique Protocol Identification Number
NCT02207803
Brief Title
A Culturally Sensitive Intervention for TBI Caregivers in Latin America
Official Title
A Culturally Sensitive Intervention for TBI Caregivers in Latin America
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Fogarty International Center of the National Institute of Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Brain Injuries, Caregivers, Intervention Studies, Latin America

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Experimental Transition Assistance Program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Transition Assistance Program
Primary Outcome Measure Information:
Title
Zarit Burden Interview
Description
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 Outcome Measure Information:
Title
Exemplary Care Scale-Provide Subscale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul B. Perrin, Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontificia Universidad Javeriana Cali
City
Cali
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Universidad Sur Colombiana
City
Neiva
ZIP/Postal Code
0000
Country
Colombia
Facility Name
National Institute of Neurology and Neurosurgery
City
Mexico City
ZIP/Postal Code
14269
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

A Culturally Sensitive Intervention for TBI Caregivers in Latin America

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