A Culturally Sensitive Intervention for TBI Caregivers in Latin America

NCT02207803 | Completed Results DMC

• 2 other identifiers: HM20001660R21TW009746
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 3

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.

Conditions

Traumatic Brain Injury

Keywords

Brain Injuries; Caregivers; Intervention Studies; Latin America

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Exemplary Care Scale-Provide Subscale

  2 months post-hospital discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Experimental Transition Assistance Program

Behavioral: Transition Assistance Program

Control

NO INTERVENTION

Control

Interventions

Transition Assistance Program BEHAVIORAL

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (3)

Pontificia Universidad Javeriana Cali

Cali, 0000, Colombia

Location

Universidad Sur Colombiana

Neiva, 0000, Colombia

Location

National Institute of Neurology and Neurosurgery

Mexico City, 14269, Mexico

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Paul Perrin
• Organization: Virginia Commonwealth University

pperrin@vcu.edu

8048273894

Study Officials

• Paul B. Perrin, Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: January 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: October 18, 2017
• Results First Posted: October 18, 2017

Record last verified: 2017-09

Locations

ME (1); CO (2)