Post-traumatic Stress Disorder, Traumatic Brain Injury
Conditions
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.
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.
Interventions
Rehabilitation via computer assisted internet capabilities
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score) | Baseline, 6 months, 12 months | Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function. |
| Craig Handicap Assessment and Reporting Technique (CHART) | 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) | 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) | 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) | 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 | 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) | Baseline, 6 Months, 12 Months | Range for Total Score: 0-40 Directionality: Higher score means more alcohol use. |
| Beck Depression Inventory Score (Total Score) | Baseline, 6 Months, 12 Months | Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms. |
Countries
United States
Participant flow
Pre-assignment details
81 participants were enrolled, but some did not participate or dropped out, leaving 75 participants who participated enough to collect data.
Participants by arm
| Arm | Count |
|---|---|
| Telerehabilitation TBI Telerehabilitation TBI
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI | 61 |
| Telerehabilitation TBI/PTSD Telerehabilitation TBI/PTSD
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI and comorbid PTSD | 14 |
| Total | 75 |
Baseline characteristics
| Characteristic | Telerehabilitation TBI | Telerehabilitation TBI/PTSD | Total |
|---|---|---|---|
| Age, Customized 18-29 years | 36 participants | 3 participants | 39 participants |
| Age, Customized 30-39 years | 15 participants | 3 participants | 18 participants |
| Age, Customized 40-49 years | 7 participants | 7 participants | 14 participants |
| Age, Customized 50+ years | 3 participants | 1 participants | 4 participants |
| Annual Income $0-9999 | 18 participants | 3 participants | 21 participants |
| Annual Income $10,000-29,999 | 25 participants | 6 participants | 31 participants |
| Annual Income $30,000-49,999 | 13 participants | 4 participants | 17 participants |
| Annual Income $50,000-79,999 | 2 participants | 1 participants | 3 participants |
| Annual Income $80,000+ | 3 participants | 0 participants | 3 participants |
| Marital status Divorced | 5 participants | 1 participants | 6 participants |
| Marital status Married | 32 participants | 7 participants | 39 participants |
| Marital status Never Married | 20 participants | 6 participants | 26 participants |
| Marital status Single | 4 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Black | 4 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Hispanic | 15 participants | 4 participants | 19 participants |
| Race/Ethnicity, Customized Native Hawaiian | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Unanswered | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized White | 39 participants | 8 participants | 47 participants |
| Region of Enrollment United States | 61 participants | 14 participants | 75 participants |
| Service Connected Disability Rating 0% | 17 participants | 5 participants | 22 participants |
| Service Connected Disability Rating 10-30% | 10 participants | 0 participants | 10 participants |
| Service Connected Disability Rating 40-60% | 14 participants | 3 participants | 17 participants |
| Service Connected Disability Rating 70-80% | 9 participants | 3 participants | 12 participants |
| Service Connected Disability Rating 80-100% | 11 participants | 3 participants | 14 participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 58 Participants | 14 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 75 |
| serious Total, serious adverse events | 4 / 75 |
Outcome results
Alcohol Use Disorders Identification Test (AUDIT) (Total Score)
Range for Total Score: 0-40 Directionality: Higher score means more alcohol use.
Time frame: Baseline, 6 Months, 12 Months
Population: Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telerehabilitation | Alcohol Use Disorders Identification Test (AUDIT) (Total Score) | Baseline (N=14) | 5.1 units on a scale | Standard Deviation 7.2 |
| Telerehabilitation | Alcohol Use Disorders Identification Test (AUDIT) (Total Score) | 6 Months (N=11) | 4.8 units on a scale | Standard Deviation 5.6 |
| Telerehabilitation | Alcohol Use Disorders Identification Test (AUDIT) (Total Score) | 12 Months (N=10) | 6 units on a scale | Standard Deviation 5.6 |
Beck Depression Inventory Score (Total Score)
Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms.
Time frame: Baseline, 6 Months, 12 Months
Population: Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telerehabilitation | Beck Depression Inventory Score (Total Score) | Baseline (N=14) | 33.1 units on a scale | Standard Deviation 13.6 |
| Telerehabilitation | Beck Depression Inventory Score (Total Score) | 6 Months (N=11) | 33.7 units on a scale | Standard Deviation 13.7 |
| Telerehabilitation | Beck Depression Inventory Score (Total Score) | 12 Months (N=10) | 30.6 units on a scale | Standard Deviation 11.8 |
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.
Time frame: Baseline, 6 Months, 12 Months
Population: Only participants with data at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telerehabilitation | Craig Handicap Assessment and Reporting Technique (CHART) | Physical Independence | 85.4 units on a scale | Standard Deviation 34.5 |
| Telerehabilitation | Craig Handicap Assessment and Reporting Technique (CHART) | Cognitive Independence | 66.8 units on a scale | Standard Deviation 28.5 |
| Telerehabilitation | Craig Handicap Assessment and Reporting Technique (CHART) | Mobility | 79.6 units on a scale | Standard Deviation 24.1 |
| Telerehabilitation | Craig Handicap Assessment and Reporting Technique (CHART) | Occupation | 69.8 units on a scale | Standard Deviation 36.9 |
| Telerehabilitation | Craig Handicap Assessment and Reporting Technique (CHART) | Social Integration | 84.4 units on a scale | Standard Deviation 22.2 |
| Telerehabilitation | Craig Handicap Assessment and Reporting Technique (CHART) | Economic Self Sufficiency | 81 units on a scale | Standard Deviation 24.2 |
| Telerehabilitation 6 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Economic Self Sufficiency | 79.7 units on a scale | Standard Deviation 27.2 |
| Telerehabilitation 6 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Physical Independence | 87.3 units on a scale | Standard Deviation 28.5 |
| Telerehabilitation 6 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Occupation | 71 units on a scale | Standard Deviation 36.6 |
| Telerehabilitation 6 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Social Integration | 76.1 units on a scale | Standard Deviation 25.9 |
| Telerehabilitation 6 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Cognitive Independence | 58.1 units on a scale | Standard Deviation 29.4 |
| Telerehabilitation 6 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Mobility | 78.9 units on a scale | Standard Deviation 23.4 |
| Telerehabilitation 12 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Cognitive Independence | 63.4 units on a scale | Standard Deviation 30.2 |
| Telerehabilitation 12 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Mobility | 79.2 units on a scale | Standard Deviation 25 |
| Telerehabilitation 12 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Economic Self Sufficiency | 77.4 units on a scale | Standard Deviation 26.5 |
| Telerehabilitation 12 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Occupation | 73.1 units on a scale | Standard Deviation 38.8 |
| Telerehabilitation 12 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Physical Independence | 70.5 units on a scale | Standard Deviation 117.1 |
| Telerehabilitation 12 Months | Craig Handicap Assessment and Reporting Technique (CHART) | Social Integration | 82.5 units on a scale | Standard Deviation 21.4 |
Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)
Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.
Time frame: Baseline, 6 months, 12 months
Population: Only participants with data at the specified time points are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telerehabilitation | Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score) | Baseline (N=65) | 175.7 units on a scale | Standard Deviation 33.7 |
| Telerehabilitation | Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score) | 6 Months (N=51) | 176.3 units on a scale | Standard Deviation 29.8 |
| Telerehabilitation | Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score) | 12 Months (N=47) | 177.6 units on a scale | Standard Deviation 26.7 |
Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score)
Range for Total Score: 0-68 Directionality: Higher score means more PTSD-related symptoms.
Time frame: Baseline, 6 Months, 12 Months
Population: Veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telerehabilitation | Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score) | Baseline (N=14) | 54.2 units on a scale | Standard Deviation 8.5 |
| Telerehabilitation | Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score) | 6 Months (N=11) | 53.3 units on a scale | Standard Deviation 11.5 |
| Telerehabilitation | Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score) | 12 Months (N=10) | 49.1 units on a scale | Standard Deviation 14.4 |
Modified PTSD Symptom Scale: Self-Report - Severity
Range for Total Score: 0 - 68 Directionality: Higher score means more PTSD-related symptoms.
Time frame: Baseline, 6 Months, 12 Months
Population: Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telerehabilitation | Modified PTSD Symptom Scale: Self-Report - Severity | 12 Months (N=10) | 55.3 units on a scale | Standard Deviation 20.6 |
| Telerehabilitation | Modified PTSD Symptom Scale: Self-Report - Severity | Baseline (N=14) | 64.1 units on a scale | Standard Deviation 14.3 |
| Telerehabilitation | Modified PTSD Symptom Scale: Self-Report - Severity | 6 Months (N=11) | 62.7 units on a scale | Standard Deviation 17.8 |
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)
Time frame: Baseline, 6 Months, 12 Months
Population: Only participants with data at the specified time were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telerehabilitation | Patient Competency Rating Scale (PCRS) (Total Score) | Baseline (N=66) | 91 units on a scale | Standard Deviation 16.2 |
| Telerehabilitation | Patient Competency Rating Scale (PCRS) (Total Score) | 6 Months (N=51) | 90.9 units on a scale | Standard Deviation 20.6 |
| Telerehabilitation | Patient Competency Rating Scale (PCRS) (Total Score) | 12 Months (N=45) | 94.4 units on a scale | Standard Deviation 21.1 |
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.
Time frame: Baseline, 6 Months, 12 Months
Population: Veterans with TBI with comorbid PTSD who were analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telerehabilitation | PTSD Checklist Military Form (PCL-M) (Total Score) | Baseline (N=14) | 63.6 units on a scale | Standard Deviation 10.6 |
| Telerehabilitation | PTSD Checklist Military Form (PCL-M) (Total Score) | 6 Months (N=11) | 64.1 units on a scale | Standard Deviation 14 |
| Telerehabilitation | PTSD Checklist Military Form (PCL-M) (Total Score) | 12 Months (N=10) | 59.4 units on a scale | Standard Deviation 12.4 |