Traumatic Brain InjuryNCT00676182
Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Post-traumatic Stress Disorder, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Traumatic Brain Injury, Post-traumatic Stress Disorder
- What is being tested?
- Telerehabilitation
- How many people
- 81 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Aug 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
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.
Read the 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 the investigators 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. The investigators 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.
The investigators recently added MyHealtheVet to the TeleRehab I care coordination for existing TeleRehab I subjects. MyHealtheVet 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.
A total of 75 of the 85 IRB-approved subjects were initially enrolled. The investigators wanted to enroll up to 10 new subjects, and the existing TeleRehab I subjects were 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. An additional 6 subjects were enrolled for a total of 81 subjects on whom demographic data was collected. Sufficient data was collected on 75 subject for analyses of their responses to surveys.
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.
- Being tested
- Telerehabilitation
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Rehabilitation via computer assisted internet capabilities
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Telerehabilitation | telerehabilitation Receives: Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)
Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kris Siddharthan, PhD MS, Principal investigator, James A. Haley Veterans' Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676182
- Sponsor's protocol ID
- SDR 08-267
- Other IDs
- a14714
- Status last verified
- Mar 2016
- First submitted
- 7 May 2008
- Last updated
- 25 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
Siddharthan K. The effect of post traumatic stress disorders on rehabilitation among combat-wounded veterans. Stud Health Technol Inform. 2012;182:114-24.
PubMed 23138086
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00676182
- Acronym / sponsor ID
- SDR 08-267
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jul 2008
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Posted 25 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 the investigators 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. The investigators 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.
The investigators recently added MyHealtheVet to the TeleRehab I care coordination for existing TeleRehab I subjects. MyHealtheVet 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.
A total of 75 of the 85 IRB-approved subjects were initially enrolled. The investigators wanted to enroll up to 10 new subjects, and the existing TeleRehab I subjects were 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. An additional 6 subjects were enrolled for a total of 81 subjects on whom demographic data was collected. Sufficient data was collected on 75 subject for analyses of their responses to surveys.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Telerehabilitation | – | Other: Telerehabilitationtelerehabilitation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationRehabilitation via computer assisted internet capabilities | Other | Arm 1: Telerehabilitation |
Primary outcome
Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)
Time frame: Baseline, 6 months, 12 months
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
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
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
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
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
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
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
Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationChapman 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.
- Results publication: PubMed 23138086Siddharthan K. The effect of post traumatic stress disorders on rehabilitation among combat-wounded veterans. Stud Health Technol Inform. 2012;182:114-24.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris Siddharthan, PhD MS principal investigator
James A. Haley Veterans' Hospital, Tampa, FL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Post-traumatic Stress Disorder, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score) (time frame: Baseline, 6 months, 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676182, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.