A Culturally Sensitive Intervention for TBI Caregivers in Latin America

September 19, 2017 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Cali, Colombia, 0000
        • Pontificia Universidad Javeriana Cali
      • Neiva, Colombia, 0000
        • Universidad Sur Colombiana
  • Mexico
      • Mexico City, Mexico, 14269
        • National Institute of Neurology and Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Intervention
Experimental Transition Assistance Program
Behavioral: Transition Assistance Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zarit Burden Interview
Time Frame: 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.
2 months post-hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exemplary Care Scale-Provide Subscale
Time Frame: 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.
2 months post-hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Fogarty International Center of the National Institute of Health

Investigators

  • Principal Investigator: Paul B. Perrin, Ph.D., Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 4, 2014

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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