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A Culturally Sensitive Intervention for TBI Caregivers in Latin America

NCT ID: NCT02207803

Last Updated: 2017-10-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Traumatic Brain Injury

Keywords

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Brain Injuries Caregivers Intervention Studies Latin America

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Intervention

Experimental Transition Assistance Program

Group Type EXPERIMENTAL

Transition Assistance Program

Intervention Type BEHAVIORAL

Control

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transition Assistance Program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul B. Perrin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Pontificia Universidad Javeriana Cali

Cali, , Colombia

Site Status

Universidad Sur Colombiana

Neiva, , Colombia

Site Status

National Institute of Neurology and Neurosurgery

Mexico City, , Mexico

Site Status

Countries

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Colombia Mexico

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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R21TW009746

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20001660

Identifier Type: -

Identifier Source: org_study_id