A Culturally Sensitive Intervention for TBI Caregivers in Latin America

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontificia Universidad Javeriana Cali, Cali, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transition Assistance Program

Behavioral

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

Fogarty International Center of the National Institute of Health

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Aug 4, 2014
Registry last updated: Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed