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| ID | Type | Description | Link |
|---|---|---|---|
| a14714 | Other Identifier | United States: Federal Government |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Telerehabilitation | telerehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Other | Rehabilitation via computer assisted internet capabilities |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kris Siddharthan, PhD MS | James A. Haley Veterans' Hospital, Tampa, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida | 32608 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 23138086 | Result | Siddharthan K. The effect of post traumatic stress disorders on rehabilitation among combat-wounded veterans. Stud Health Technol Inform. 2012;182:114-24. |
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81 participants were enrolled, but some did not participate or dropped out, leaving 75 participants who participated enough to collect data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telerehabilitation | telerehabilitation Telerehabilitation: Rehabilitation via computer assisted internet capabilities |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telerehabilitation TBI | Telerehabilitation TBI Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI |
| BG001 | Telerehabilitation TBI/PTSD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score) | Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function. | Only participants with data at the specified time points are included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months, 12 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telerehabilitation | telerehabilitation Telerehabilitation: Rehabilitation via computer assisted internet capabilities |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kris Siddharthan | James A. Haley Veterans' Hospital | 813-558-3950 | Krishnaswami.Siddharthan@va.gov |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| 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 |
| James A. Haley Veterans' Hospital, Tampa, FL |
| Tampa |
| Florida |
| 33612 |
| United States |
Telerehabilitation TBI/PTSD
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI and comorbid PTSD
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Service Connected Disability Rating | Percent of service-connected disability | Number | participants |
|
| Annual Income | Number | participants |
|
| Marital status | Number | participants |
|
|
|
| Primary | 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. | Only participants with data at the specified time points were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Months, 12 Months |
|
|
|
| Primary | 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) | Only participants with data at the specified time were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Months, 12 Months |
|
|
|
| Primary | 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. | Veterans with TBI with comorbid PTSD who were analyzed at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Months, 12 Months |
|
|
|
| Primary | Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score) | Range for Total Score: 0-68 Directionality: Higher score means more PTSD-related symptoms. | Veterans with TBI and comorbid PTSD with data at the specified time point were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Months, 12 Months |
|
|
|
| Primary | Modified PTSD Symptom Scale: Self-Report - Severity | Range for Total Score: 0 - 68 Directionality: Higher score means more PTSD-related symptoms. | Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Months, 12 Months |
|
|
|
| Primary | Alcohol Use Disorders Identification Test (AUDIT) (Total Score) | Range for Total Score: 0-40 Directionality: Higher score means more alcohol use. | Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Months, 12 Months |
|
|
|
| Primary | Beck Depression Inventory Score (Total Score) | Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms. | Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Months, 12 Months |
|
|
|
| 4 |
| 75 |
| 0 |
| 75 |
| Hospitalization due to suicidal ideation | General disorders | Non-systematic Assessment |
|
| Hospitalization | General disorders | Non-systematic Assessment | event leading to hospitalization unknown |
|
| Hospitalization | General disorders | Non-systematic Assessment | event unknown |
|
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
|
| Mobility |
|
| Occupation |
|
| Social Integration |
|
| Economic Self Sufficiency |
|
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|---|---|
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