Telerehabilitation for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Returnees With Combat-Related Telerehab for Traumatic Brain Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00676182
First received: May 7, 2008
Last updated: September 16, 2014
Last verified: September 2014
  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

Study Type: Interventional
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

Resource links provided by NLM:


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: 85
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)
Arms Assigned Interventions
Experimental: Arm 1
telerehabilitation
Other: Telerehabilitation
Rehabilitation via computer assisted internet capabilities
Other Name: Telerehabilitation

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.

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.

  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.

In order to add MyHealtheVet to the study as a method of care coordination, MyHealtheVet enrollment and secure messaging authentication is required to continue in the study. 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.

Exclusion Criteria:

  • Telerehab services will be offered only to those patients with low ADLs who require additional care and who stand to benefit from the care coordination program.
  • We will also exclude those who are severely injured or institutionalized. This includes patients with a severe psychopathology.
  • Refusal to enroll in MyHealtheVet with Secure Messaging will eventually lead to subjects being dropped from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676182

Locations
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
Sponsors and Collaborators
Investigators
Principal Investigator: Kris Siddharthan, PhD MS James A. Haley Veterans' Hospital
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00676182     History of Changes
Other Study ID Numbers: SDR 08-267, a14714
Study First Received: May 7, 2008
Last Updated: September 16, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Brain Injuries
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Mental Disorders
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014