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

NCT00676182 | Completed Results

• 2 other identifiers: SDR 08-267a14714
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Traumatic Brain Injury; Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (8)

• Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)

  Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.

  Baseline, 6 months, 12 months

• Craig Handicap Assessment and Reporting Technique (CHART)

  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.

  Baseline, 6 Months, 12 Months

• Patient Competency Rating Scale (PCRS) (Total Score)

  Range for total score: 30 - 150 Directionality for total score: higher score means higher competency (can do things with greater ease)

  Baseline, 6 Months, 12 Months

• PTSD Checklist Military Form (PCL-M) (Total Score)

  Range for total score: 17- 85 Directionality for total score: Higher score means experiencing more PTSD-related problems.

  Baseline, 6 Months, 12 Months

• Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score)

  Range for Total Score: 0-68 Directionality: Higher score means more PTSD-related symptoms.

  Baseline, 6 Months, 12 Months

• Modified PTSD Symptom Scale: Self-Report - Severity

  Range for Total Score: 0 - 68 Directionality: Higher score means more PTSD-related symptoms.

  Baseline, 6 Months, 12 Months

• Alcohol Use Disorders Identification Test (AUDIT) (Total Score)

  Range for Total Score: 0-40 Directionality: Higher score means more alcohol use.

  Baseline, 6 Months, 12 Months

• Beck Depression Inventory Score (Total Score)

  Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms.

  Baseline, 6 Months, 12 Months

Study Arms (1)

Arm 1: Telerehabilitation

telerehabilitation

Other: Telerehabilitation

Interventions

Telerehabilitation OTHER

Rehabilitation via computer assisted internet capabilities

Arm 1: Telerehabilitation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Related Publications (2)

• 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.

  RESULT

• Siddharthan K. The effect of post traumatic stress disorders on rehabilitation among combat-wounded veterans. Stud Health Technol Inform. 2012;182:114-24.

  PMID: 23138086 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr. Kris Siddharthan
• Organization: James A. Haley Veterans' Hospital

Krishnaswami.Siddharthan@va.gov

813-558-3950

Study Officials

• Kris Siddharthan, PhD MS

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 12, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 25, 2016
• Results First Posted: March 25, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)