Trial Outcomes & Findings for Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury (NCT NCT00676182)
NCT ID: NCT00676182
Last Updated: 2016-03-25
Results Overview
Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.
Recruitment status
COMPLETED
Target enrollment
81 participants
Primary outcome timeframe
Baseline, 6 months, 12 months
Results posted on
2016-03-25
Participant Flow
81 participants were enrolled, but some did not participate or dropped out, leaving 75 participants who participated enough to collect data.
Participant milestones
| Measure |
Telerehabilitation
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Telerehabilitation TBI
n=61 Participants
Telerehabilitation TBI
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI
|
Telerehabilitation TBI/PTSD
n=14 Participants
Telerehabilitation TBI/PTSD
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI and comorbid PTSD
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-29 years
|
36 participants
n=5 Participants
|
3 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
15 participants
n=5 Participants
|
3 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Age, Customized
50+ years
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
39 participants
n=5 Participants
|
8 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
15 participants
n=5 Participants
|
4 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unanswered
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
14 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Service Connected Disability Rating
0%
|
17 participants
n=5 Participants
|
5 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Service Connected Disability Rating
10-30%
|
10 participants
n=5 Participants
|
0 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Service Connected Disability Rating
40-60%
|
14 participants
n=5 Participants
|
3 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Service Connected Disability Rating
70-80%
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Service Connected Disability Rating
80-100%
|
11 participants
n=5 Participants
|
3 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Annual Income
$0-9999
|
18 participants
n=5 Participants
|
3 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Annual Income
$10,000-29,999
|
25 participants
n=5 Participants
|
6 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Annual Income
$30,000-49,999
|
13 participants
n=5 Participants
|
4 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Annual Income
$50,000-79,999
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Annual Income
$80,000+
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Marital status
Married
|
32 participants
n=5 Participants
|
7 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Marital status
Divorced
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Marital status
Never Married
|
20 participants
n=5 Participants
|
6 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Marital status
Single
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Only participants with data at the specified time points are included in the analysis.
Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.
Outcome measures
| Measure |
Telerehabilitation
n=65 Participants
Telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects
|
Telerehabilitation 6 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
Telerehabilitation 12 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
|---|---|---|---|
|
Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)
Baseline (N=65)
|
175.7 units on a scale
Standard Deviation 33.7
|
—
|
—
|
|
Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)
6 Months (N=51)
|
176.3 units on a scale
Standard Deviation 29.8
|
—
|
—
|
|
Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)
12 Months (N=47)
|
177.6 units on a scale
Standard Deviation 26.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 6 Months, 12 MonthsPopulation: Only participants with data at the specified time points were analyzed.
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.
Outcome measures
| Measure |
Telerehabilitation
n=66 Participants
Telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects
|
Telerehabilitation 6 Months
n=51 Participants
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
Telerehabilitation 12 Months
n=47 Participants
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
|---|---|---|---|
|
Craig Handicap Assessment and Reporting Technique (CHART)
Mobility
|
79.6 units on a scale
Standard Deviation 24.1
|
78.9 units on a scale
Standard Deviation 23.4
|
79.2 units on a scale
Standard Deviation 25
|
|
Craig Handicap Assessment and Reporting Technique (CHART)
Physical Independence
|
85.4 units on a scale
Standard Deviation 34.5
|
87.3 units on a scale
Standard Deviation 28.5
|
70.5 units on a scale
Standard Deviation 117.1
|
|
Craig Handicap Assessment and Reporting Technique (CHART)
Cognitive Independence
|
66.8 units on a scale
Standard Deviation 28.5
|
58.1 units on a scale
Standard Deviation 29.4
|
63.4 units on a scale
Standard Deviation 30.2
|
|
Craig Handicap Assessment and Reporting Technique (CHART)
Occupation
|
69.8 units on a scale
Standard Deviation 36.9
|
71 units on a scale
Standard Deviation 36.6
|
73.1 units on a scale
Standard Deviation 38.8
|
|
Craig Handicap Assessment and Reporting Technique (CHART)
Social Integration
|
84.4 units on a scale
Standard Deviation 22.2
|
76.1 units on a scale
Standard Deviation 25.9
|
82.5 units on a scale
Standard Deviation 21.4
|
|
Craig Handicap Assessment and Reporting Technique (CHART)
Economic Self Sufficiency
|
81 units on a scale
Standard Deviation 24.2
|
79.7 units on a scale
Standard Deviation 27.2
|
77.4 units on a scale
Standard Deviation 26.5
|
PRIMARY outcome
Timeframe: Baseline, 6 Months, 12 MonthsPopulation: Only participants with data at the specified time were analyzed.
Range for total score: 30 - 150 Directionality for total score: higher score means higher competency (can do things with greater ease)
Outcome measures
| Measure |
Telerehabilitation
n=66 Participants
Telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects
|
Telerehabilitation 6 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
Telerehabilitation 12 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
|---|---|---|---|
|
Patient Competency Rating Scale (PCRS) (Total Score)
Baseline (N=66)
|
91 units on a scale
Standard Deviation 16.2
|
—
|
—
|
|
Patient Competency Rating Scale (PCRS) (Total Score)
6 Months (N=51)
|
90.9 units on a scale
Standard Deviation 20.6
|
—
|
—
|
|
Patient Competency Rating Scale (PCRS) (Total Score)
12 Months (N=45)
|
94.4 units on a scale
Standard Deviation 21.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 6 Months, 12 MonthsPopulation: Veterans with TBI with comorbid PTSD who were analyzed at the specified time point.
Range for total score: 17- 85 Directionality for total score: Higher score means experiencing more PTSD-related problems.
Outcome measures
| Measure |
Telerehabilitation
n=14 Participants
Telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects
|
Telerehabilitation 6 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
Telerehabilitation 12 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
|---|---|---|---|
|
PTSD Checklist Military Form (PCL-M) (Total Score)
Baseline (N=14)
|
63.6 units on a scale
Standard Deviation 10.6
|
—
|
—
|
|
PTSD Checklist Military Form (PCL-M) (Total Score)
6 Months (N=11)
|
64.1 units on a scale
Standard Deviation 14
|
—
|
—
|
|
PTSD Checklist Military Form (PCL-M) (Total Score)
12 Months (N=10)
|
59.4 units on a scale
Standard Deviation 12.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 6 Months, 12 MonthsPopulation: Veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.
Range for Total Score: 0-68 Directionality: Higher score means more PTSD-related symptoms.
Outcome measures
| Measure |
Telerehabilitation
n=14 Participants
Telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects
|
Telerehabilitation 6 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
Telerehabilitation 12 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
|---|---|---|---|
|
Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score)
Baseline (N=14)
|
54.2 units on a scale
Standard Deviation 8.5
|
—
|
—
|
|
Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score)
6 Months (N=11)
|
53.3 units on a scale
Standard Deviation 11.5
|
—
|
—
|
|
Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score)
12 Months (N=10)
|
49.1 units on a scale
Standard Deviation 14.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 6 Months, 12 MonthsPopulation: Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.
Range for Total Score: 0 - 68 Directionality: Higher score means more PTSD-related symptoms.
Outcome measures
| Measure |
Telerehabilitation
n=14 Participants
Telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects
|
Telerehabilitation 6 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
Telerehabilitation 12 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
|---|---|---|---|
|
Modified PTSD Symptom Scale: Self-Report - Severity
Baseline (N=14)
|
64.1 units on a scale
Standard Deviation 14.3
|
—
|
—
|
|
Modified PTSD Symptom Scale: Self-Report - Severity
6 Months (N=11)
|
62.7 units on a scale
Standard Deviation 17.8
|
—
|
—
|
|
Modified PTSD Symptom Scale: Self-Report - Severity
12 Months (N=10)
|
55.3 units on a scale
Standard Deviation 20.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 6 Months, 12 MonthsPopulation: Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.
Range for Total Score: 0-40 Directionality: Higher score means more alcohol use.
Outcome measures
| Measure |
Telerehabilitation
n=14 Participants
Telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects
|
Telerehabilitation 6 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
Telerehabilitation 12 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
|---|---|---|---|
|
Alcohol Use Disorders Identification Test (AUDIT) (Total Score)
Baseline (N=14)
|
5.1 units on a scale
Standard Deviation 7.2
|
—
|
—
|
|
Alcohol Use Disorders Identification Test (AUDIT) (Total Score)
6 Months (N=11)
|
4.8 units on a scale
Standard Deviation 5.6
|
—
|
—
|
|
Alcohol Use Disorders Identification Test (AUDIT) (Total Score)
12 Months (N=10)
|
6 units on a scale
Standard Deviation 5.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 6 Months, 12 MonthsPopulation: Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.
Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms.
Outcome measures
| Measure |
Telerehabilitation
n=14 Participants
Telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects
|
Telerehabilitation 6 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
Telerehabilitation 12 Months
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
|---|---|---|---|
|
Beck Depression Inventory Score (Total Score)
Baseline (N=14)
|
33.1 units on a scale
Standard Deviation 13.6
|
—
|
—
|
|
Beck Depression Inventory Score (Total Score)
6 Months (N=11)
|
33.7 units on a scale
Standard Deviation 13.7
|
—
|
—
|
|
Beck Depression Inventory Score (Total Score)
12 Months (N=10)
|
30.6 units on a scale
Standard Deviation 11.8
|
—
|
—
|
Adverse Events
Telerehabilitation
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telerehabilitation
n=75 participants at risk
telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities
|
|---|---|
|
General disorders
Death
|
1.3%
1/75 • Number of events 1
|
|
General disorders
Hospitalization due to suicidal ideation
|
1.3%
1/75 • Number of events 1
|
|
General disorders
Hospitalization
|
1.3%
1/75 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place