N/A
N=75
Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury
Traumatic Brain Injury · Post-traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00676182 ↗Enrolled (actual)
75
Serious AEs
5.3%
Results posted
Mar 2016
Primary outcome: Primary: Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score) — 175.7; 176.3; 177.6 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Telerehabilitation (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score) |
175.7; 176.3; 177.6 | — |
| PRIMARY Craig Handicap Assessment and Reporting Technique (CHART) |
85.4; 87.3; 70.5; 66.8; 58.1; 63.4 | — |
| PRIMARY Patient Competency Rating Scale (PCRS) (Total Score) |
91; 90.9; 94.4 | — |
| PRIMARY PTSD Checklist Military Form (PCL-M) (Total Score) |
63.6; 64.1; 59.4 | — |
| PRIMARY Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score) |
54.2; 53.3; 49.1 | — |
| PRIMARY Modified PTSD Symptom Scale: Self-Report - Severity |
64.1; 62.7; 55.3 | — |
| PRIMARY Alcohol Use Disorders Identification Test (AUDIT) (Total Score) |
5.1; 4.8; 6 | — |
| PRIMARY Beck Depression Inventory Score (Total Score) |
33.1; 33.7; 30.6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00676182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.