Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00676182
First received: May 7, 2008
Last updated: March 24, 2016
Last verified: March 2016
  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. The investigators 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: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score) [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.

  • Craig Handicap Assessment and Reporting Technique (CHART) [ Time Frame: Baseline, 6 Months, 12 Months ] [ Designated as safety issue: No ]

    Ranges for Subscales: 0 - 100 Physical Independence: 4 -100 Cognitive Independence: 0 -100 Mobility: 0 -100 Occupation: 0 -100 Social Integration: 0 -100 Economic Self Sufficiency: 0-100

    Directionality: for each subscale, higher score means more independence; lower score means needs more assistance.


  • Patient Competency Rating Scale (PCRS) (Total Score) [ Time Frame: Baseline, 6 Months, 12 Months ] [ Designated as safety issue: No ]
    Range for total score: 30 - 150 Directionality for total score: higher score means higher competency (can do things with greater ease)

  • PTSD Checklist Military Form (PCL-M) (Total Score) [ Time Frame: Baseline, 6 Months, 12 Months ] [ Designated as safety issue: No ]
    Range for total score: 17- 85 Directionality for total score: Higher score means experiencing more PTSD-related problems.

  • Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score) [ Time Frame: Baseline, 6 Months, 12 Months ] [ Designated as safety issue: No ]
    Range for Total Score: 0-68 Directionality: Higher score means more PTSD-related symptoms.

  • Modified PTSD Symptom Scale: Self-Report - Severity [ Time Frame: Baseline, 6 Months, 12 Months ] [ Designated as safety issue: No ]
    Range for Total Score: 0 - 68 Directionality: Higher score means more PTSD-related symptoms.

  • Alcohol Use Disorders Identification Test (AUDIT) (Total Score) [ Time Frame: Baseline, 6 Months, 12 Months ] [ Designated as safety issue: No ]
    Range for Total Score: 0-40 Directionality: Higher score means more alcohol use.

  • Beck Depression Inventory Score (Total Score) [ Time Frame: Baseline, 6 Months, 12 Months ] [ Designated as safety issue: No ]
    Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms.


Enrollment: 81
Study Start Date: July 2008
Study Completion Date: August 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm 1: Telerehabilitation
telerehabilitation
Other: Telerehabilitation
Rehabilitation via computer assisted internet capabilities

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Convenience sample of OIF/OEF Veterans discharged from the James A. Haley Veterans' Hospital in Tampa, FL with a diagnosis of mild/moderate TBI with or without comorbid PTSD.
Criteria

Inclusion Criteria:

  • Veterans or active duty military personnel discharged from the James A. Haley Veterans' Hospital in Tampa, FL or in rehabilitation there
  • 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.
  • The investigators 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, FL
Gainesville, Florida, United States, 32608
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Kris Siddharthan, PhD MS James A. Haley Veterans' Hospital, Tampa, FL
  More Information

Publications:
Chapman PL, Elnitsky CA, Thurman R, Spehar AM, Siddharthan K. Exploring combat-related loss and behavioral health among OIF/OIF Veterans with chronic PTSD. Traumatology. 2013 Jun 1; 19(2):154-157.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00676182     History of Changes
Other Study ID Numbers: SDR 08-267  a14714 
Study First Received: May 7, 2008
Results First Received: March 24, 2016
Last Updated: March 24, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on August 25, 2016