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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00676182
Enrollment
81
Registered
2008-05-12
Start date
2008-07-31
Completion date
2015-08-31
Last updated
2016-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic Stress Disorder, Traumatic Brain Injury

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

OTHERTelerehabilitation

Rehabilitation via computer assisted internet capabilities

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)Baseline, 6 months, 12 monthsRange: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.
Craig Handicap Assessment and Reporting Technique (CHART)Baseline, 6 Months, 12 MonthsRanges 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 MonthsRange 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 MonthsRange 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 MonthsRange for Total Score: 0-68 Directionality: Higher score means more PTSD-related symptoms.
Modified PTSD Symptom Scale: Self-Report - SeverityBaseline, 6 Months, 12 MonthsRange 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 MonthsRange for Total Score: 0-40 Directionality: Higher score means more alcohol use.
Beck Depression Inventory Score (Total Score)Baseline, 6 Months, 12 MonthsRange 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

ArmCount
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
Total75

Baseline characteristics

CharacteristicTelerehabilitation TBITelerehabilitation TBI/PTSDTotal
Age, Customized
18-29 years
36 participants3 participants39 participants
Age, Customized
30-39 years
15 participants3 participants18 participants
Age, Customized
40-49 years
7 participants7 participants14 participants
Age, Customized
50+ years
3 participants1 participants4 participants
Annual Income
$0-9999
18 participants3 participants21 participants
Annual Income
$10,000-29,999
25 participants6 participants31 participants
Annual Income
$30,000-49,999
13 participants4 participants17 participants
Annual Income
$50,000-79,999
2 participants1 participants3 participants
Annual Income
$80,000+
3 participants0 participants3 participants
Marital status
Divorced
5 participants1 participants6 participants
Marital status
Married
32 participants7 participants39 participants
Marital status
Never Married
20 participants6 participants26 participants
Marital status
Single
4 participants0 participants4 participants
Race/Ethnicity, Customized
Black
4 participants0 participants4 participants
Race/Ethnicity, Customized
Hispanic
15 participants4 participants19 participants
Race/Ethnicity, Customized
Native Hawaiian
1 participants1 participants2 participants
Race/Ethnicity, Customized
Unanswered
2 participants1 participants3 participants
Race/Ethnicity, Customized
White
39 participants8 participants47 participants
Region of Enrollment
United States
61 participants14 participants75 participants
Service Connected Disability Rating
0%
17 participants5 participants22 participants
Service Connected Disability Rating
10-30%
10 participants0 participants10 participants
Service Connected Disability Rating
40-60%
14 participants3 participants17 participants
Service Connected Disability Rating
70-80%
9 participants3 participants12 participants
Service Connected Disability Rating
80-100%
11 participants3 participants14 participants
Sex: Female, Male
Female
3 Participants0 Participants3 Participants
Sex: Female, Male
Male
58 Participants14 Participants72 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 75
serious
Total, serious adverse events
4 / 75

Outcome results

Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
TelerehabilitationAlcohol Use Disorders Identification Test (AUDIT) (Total Score)Baseline (N=14)5.1 units on a scaleStandard Deviation 7.2
TelerehabilitationAlcohol Use Disorders Identification Test (AUDIT) (Total Score)6 Months (N=11)4.8 units on a scaleStandard Deviation 5.6
TelerehabilitationAlcohol Use Disorders Identification Test (AUDIT) (Total Score)12 Months (N=10)6 units on a scaleStandard Deviation 5.6
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
TelerehabilitationBeck Depression Inventory Score (Total Score)Baseline (N=14)33.1 units on a scaleStandard Deviation 13.6
TelerehabilitationBeck Depression Inventory Score (Total Score)6 Months (N=11)33.7 units on a scaleStandard Deviation 13.7
TelerehabilitationBeck Depression Inventory Score (Total Score)12 Months (N=10)30.6 units on a scaleStandard Deviation 11.8
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.

Time frame: Baseline, 6 Months, 12 Months

Population: Only participants with data at the specified time points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
TelerehabilitationCraig Handicap Assessment and Reporting Technique (CHART)Physical Independence85.4 units on a scaleStandard Deviation 34.5
TelerehabilitationCraig Handicap Assessment and Reporting Technique (CHART)Cognitive Independence66.8 units on a scaleStandard Deviation 28.5
TelerehabilitationCraig Handicap Assessment and Reporting Technique (CHART)Mobility79.6 units on a scaleStandard Deviation 24.1
TelerehabilitationCraig Handicap Assessment and Reporting Technique (CHART)Occupation69.8 units on a scaleStandard Deviation 36.9
TelerehabilitationCraig Handicap Assessment and Reporting Technique (CHART)Social Integration84.4 units on a scaleStandard Deviation 22.2
TelerehabilitationCraig Handicap Assessment and Reporting Technique (CHART)Economic Self Sufficiency81 units on a scaleStandard Deviation 24.2
Telerehabilitation 6 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Economic Self Sufficiency79.7 units on a scaleStandard Deviation 27.2
Telerehabilitation 6 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Physical Independence87.3 units on a scaleStandard Deviation 28.5
Telerehabilitation 6 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Occupation71 units on a scaleStandard Deviation 36.6
Telerehabilitation 6 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Social Integration76.1 units on a scaleStandard Deviation 25.9
Telerehabilitation 6 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Cognitive Independence58.1 units on a scaleStandard Deviation 29.4
Telerehabilitation 6 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Mobility78.9 units on a scaleStandard Deviation 23.4
Telerehabilitation 12 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Cognitive Independence63.4 units on a scaleStandard Deviation 30.2
Telerehabilitation 12 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Mobility79.2 units on a scaleStandard Deviation 25
Telerehabilitation 12 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Economic Self Sufficiency77.4 units on a scaleStandard Deviation 26.5
Telerehabilitation 12 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Occupation73.1 units on a scaleStandard Deviation 38.8
Telerehabilitation 12 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Physical Independence70.5 units on a scaleStandard Deviation 117.1
Telerehabilitation 12 MonthsCraig Handicap Assessment and Reporting Technique (CHART)Social Integration82.5 units on a scaleStandard Deviation 21.4
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
TelerehabilitationFunctional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)Baseline (N=65)175.7 units on a scaleStandard Deviation 33.7
TelerehabilitationFunctional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)6 Months (N=51)176.3 units on a scaleStandard Deviation 29.8
TelerehabilitationFunctional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)12 Months (N=47)177.6 units on a scaleStandard Deviation 26.7
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
TelerehabilitationModified PTSD Symptom Scale: Self-Report - Frequency (Total Score)Baseline (N=14)54.2 units on a scaleStandard Deviation 8.5
TelerehabilitationModified PTSD Symptom Scale: Self-Report - Frequency (Total Score)6 Months (N=11)53.3 units on a scaleStandard Deviation 11.5
TelerehabilitationModified PTSD Symptom Scale: Self-Report - Frequency (Total Score)12 Months (N=10)49.1 units on a scaleStandard Deviation 14.4
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
TelerehabilitationModified PTSD Symptom Scale: Self-Report - Severity12 Months (N=10)55.3 units on a scaleStandard Deviation 20.6
TelerehabilitationModified PTSD Symptom Scale: Self-Report - SeverityBaseline (N=14)64.1 units on a scaleStandard Deviation 14.3
TelerehabilitationModified PTSD Symptom Scale: Self-Report - Severity6 Months (N=11)62.7 units on a scaleStandard Deviation 17.8
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)

Time frame: Baseline, 6 Months, 12 Months

Population: Only participants with data at the specified time were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
TelerehabilitationPatient Competency Rating Scale (PCRS) (Total Score)Baseline (N=66)91 units on a scaleStandard Deviation 16.2
TelerehabilitationPatient Competency Rating Scale (PCRS) (Total Score)6 Months (N=51)90.9 units on a scaleStandard Deviation 20.6
TelerehabilitationPatient Competency Rating Scale (PCRS) (Total Score)12 Months (N=45)94.4 units on a scaleStandard Deviation 21.1
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.

Time frame: Baseline, 6 Months, 12 Months

Population: Veterans with TBI with comorbid PTSD who were analyzed at the specified time point.

ArmMeasureGroupValue (MEAN)Dispersion
TelerehabilitationPTSD Checklist Military Form (PCL-M) (Total Score)Baseline (N=14)63.6 units on a scaleStandard Deviation 10.6
TelerehabilitationPTSD Checklist Military Form (PCL-M) (Total Score)6 Months (N=11)64.1 units on a scaleStandard Deviation 14
TelerehabilitationPTSD Checklist Military Form (PCL-M) (Total Score)12 Months (N=10)59.4 units on a scaleStandard Deviation 12.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026