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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00676182 |
The scientific objective of this program is to meet the rehabilitation needs of combat wounded veterans with mild to moderate Traumatic Brain Injury (TBI) via telerehabilitation and determine the effect of this modality of care on patients' physical health and outcomes including function and community participation. We will also evaluate the benefits and limitations of rehabilitation using telehealth from the veteran and caregiver perspectives and evaluate the impact of rehabilitation via telehealth on Veterans Administration (VA) healthcare facility use.
Condition | Intervention |
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Traumatic Brain Injury Post-Traumatic Stress Disorder |
Other: Telerehabilitation |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury |
Estimated Enrollment: | 60 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
telerehabilitation
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Other: Telerehabilitation
Rehabilitation via computer assisted internet capabilities
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Rational: TBI can cause life-long impairments in physical, cognitive, behavioral and social function that are usually more disabling than the residual physical deficits. Recovery can continue many years after initial trauma. Little is known about optimal methodologies to treat the vast and complicated secondary manifestations of combat related TBI. Applicability: The goal of this rehabilitation program is eventually to optimally define telerehabilitation services for all veterans with polytrauma, including accurate and efficient screening instruments, educational material for patients and families, family support, and family counseling to enhance care coordination and to maximize functional outcomes and quality of life.
Patient population: The program will help wounded veterans with a diagnosis of TBI from combat operations in Iraq and Afghanistan. Many veterans reside in rural and underserved areas. Although access to health care for rural patients remains a critical challenge, telerehabilitation may represent a viable means for the delivery of therapeutic services to such patients, particularly those served by the VA. The program has implications for civilian populations as well including those injured in automobile or industrial accidents and similar in illness to the cohort of veterans we intend to follow. Clinical applications, benefits and risks: The goals of the rehabilitation project will be to enhance the wounded veteran's capacity to process and interpret information and to improve his ability to function in all aspects of family and community life. It will involve a combination of restorative training which focuses on improving a specific cognitive function and compensatory training which educates veterans on adapting to the presence of a cognitive deficit that may or may not be curable using singular one to one interventions as well as integrated interdisciplinary approaches to target multiple conditions. We see no risks involved in this clinical intervention. Projected time to achieve a consumer-related outcome: The results of the telerehabilitation project should immediately be available for dissemination throughout the VA. The VA has already committed itself to a nationwide rollout of similar telerehabilitation projects for wounded veterans. Hence, the findings should have immediate application in VA care for returnees from combat.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sue Brock, RN | (813) 972-2000 ext 5169 | sue.brock@va.gov |
United States, Florida | |
VISN 8 Patient Safety Center | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Kris Siddharthan, PhD MS 813-558-3950 Kris.Siddharthan@va.gov | |
Contact: Andrea M Spehar, DVM MPH JD (813) 558-3947 Andrea.Spehar@va.gov | |
Principal Investigator: Kris Siddharthan, PhD MS | |
North Florida/South Georgia Veterans Health System | Recruiting |
Gainesville, Florida, United States, 32608 | |
Contact: Charles E Levy, MD BA 352-374-6065 Charles.Levy@va.gov | |
Sub-Investigator: Charles E. Levy, MD BA |
Principal Investigator: | Kris Siddharthan, PhD MS | VISN 8 Patient Safety Center |
Responsible Party: | Department of Veterans Affairs ( Siddharthan, Kris - Principal Investigator ) |
Study ID Numbers: | SDR 08-267, a14714 |
Study First Received: | May 7, 2008 |
Last Updated: | March 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00676182 History of Changes |
Health Authority: | United States: Federal Government |
Craniocerebral Trauma Anxiety Disorders Mental Disorders Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Stress Disorders, Post-Traumatic Stress Trauma, Nervous System Brain Diseases Brain Injuries Stress Disorders, Traumatic |
Craniocerebral Trauma Anxiety Disorders Mental Disorders Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin |
Central Nervous System Diseases Stress Disorders, Post-Traumatic Trauma, Nervous System Brain Diseases Brain Injuries Stress Disorders, Traumatic |