Telerehabilitation for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Returnees With Combat-Related Telerehab for Traumatic Brain Injury
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.
Traumatic Brain Injury
Post-traumatic Stress Disorder
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury|
- Functional and cognitive status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Rehabilitation via computer assisted internet capabilities
Other Name: Telerehabilitation
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.
We recently added MyHealtheVet to the TeleRehab I care coordination for existing TeleRehab I subjects. My HealtheVet is the VA's Personal Health Record and offers Veterans an additional way for Veterans to partner with the health care team in making informed decisions. MyHealtheVet is an existing, innovative program available to Veterans throughout the VA. (see https://www.myhealth.va.gov/index.html for additional information) Most of the remaining TeleRehabilitation Veterans are already enrolled in the MyHealtheVet program. Besides giving patients access to their health records and online prescription ordering, there is a secure messaging system with VA providers, who can save the secure message into the patient's electronic medical record (CPRS) with a single click.
2. A total of 75 of the 85 IRB-approved subjects were enrolled. We will be enrolling up to 10 new subjects, and the existing TeleRehab I subjects will all be asked to sign a revised ICF that adds MyHealtheVet to the study, and makes other changes to the ICF required by Tampa VA R&D. If the subjects consent they will be required to register and be authenticated to use MyHealtheVet in order to participate or continue to participate in the study.
3. MyHealtheVet enrollment and secure messaging authentication is required to continue in the study, and changes to the protocol will reflect this additional eligibility criterion. All other methods of communication with subjects and existing surveys will continue. Eventually MyHealtheVet will replace the LAMP for secure communications with the Care Coordinator.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676182
|United States, Florida|
|North Florida/South Georgia Veterans Health System|
|Gainesville, Florida, United States, 32608|
|James A. Haley Veterans Hospital|
|Tampa, Florida, United States, 33637-1022|
|Principal Investigator:||Kris Siddharthan, PhD MS||James A. Haley Veterans' Hospital|