Full Text View
Tabular View
No Study Results Posted
Related Studies
Telerehabilitation for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Returnees With Combat-Related Telerehab for Traumatic Brain Injury
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, March 2009
First Received: May 7, 2008   Last Updated: March 17, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00676182
  Purpose

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
Traumatic Brain Injury
Post-Traumatic Stress Disorder
Other: Telerehabilitation

MedlinePlus related topics: Post-Traumatic Stress Disorder Rehabilitation Surgery Traumatic Brain Injury
U.S. FDA Resources
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

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Functional and cognitive status [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
1: Experimental
telerehabilitation
Other: Telerehabilitation
Rehabilitation via computer assisted internet capabilities

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans or active duty military personnel awaiting discharge while in rehabilitation
  • ages 18 and older
  • have sustained a TBI as evidenced by primary or secondary diagnosis on initial admission, with or without comorbid Post-traumatic Stress Disorder (PTSD)
  • enrolled and receiving medical services through the Tampa VA and medically stable as clinically determined by the patient's physician.

Exclusion Criteria:

  • TBI LAMP services will be offered only to those patients with low ADLs who require additional care and who in the opinion of Dr. Steven Scott and the ARNP will stand to benefit from the care coordination program.
  • We will also exclude those who are so severely injured they are institutionalized. This includes patients with a severe psychopathology.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676182

Contacts
Contact: Sue Brock, RN (813) 972-2000 ext 5169 sue.brock@va.gov

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: Kris Siddharthan, PhD MS VISN 8 Patient Safety Center
  More Information

No publications provided

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009