Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01714531
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2012-10-22
Brief Title:
Improving Outcomes After Traumatic Injury A Goal Management Approach
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Improving Trauma Outcomes A Goal Management Approach
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GMT
Brief Summary:
The majority of trauma survivors experience prolonged and profound physical and psychosocial disability with up to 50 unable to return to productive employment The Centers for Disease Control CDC estimates that more than 1 million of these individuals experience a mild traumatic brain injury TBI and cost the United States nearly 17 billion each year Symptoms related to mild TBI result in cognitive functional and emotional impairments that can lead to vocational and social disability Long-term cognitive deficits include problems with memory and attention and most importantly executive functioning Depressive and post-traumatic stress disorder PTSD symptoms are extremely common in individuals with cognitive impairment occurring in up to 50 and 33 of individuals respectively The investigators have found that 55 of trauma patients with mild TBI have profound cognitive impairments in executive functioning at one-year survival Executive functioning is defined as a cognitive domain that controls the execution of complex activities of daily living essential for purposeful goal directed behaviors Deficits in executive functioning are the most disabling of all cognitive impairments and affect a persons ability to manage effectively in ones personal and professional life Current literature shows that deficits in executive functioning contribute to reduced quality of life difficulty in returning to work and persistent psychological distress in various medical and surgical populations Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment and functional disability in patients with TBI The overall goal of cognitive rehabilitation is not only to improve a persons ability to process and interpret information but to increase self-confidence and self-efficacy for coping with emotional distress Despite evidence supporting the use of cognitive rehabilitation few studies have systematically addressed cognitive treatment for individuals with mild TBI Therefore the investigators propose to conduct a three-group randomized controlled trial to determine the efficacy of Goal Management Training GMT a structured manual-based intervention targeting executive functions that impact a persons ability to carry out daily tasks The investigators hypothesize that telephone-based GMT will improve cognitive functioning functional status and psychological health in trauma survivors with mild TBI Emerging research suggests that telephone rehabilitation is a feasible and effective alternative with much broader applicability to clinic-based interventions Trauma survivors with mild TBI have limited access to rehabilitation services due to financial constraints and mobility and geographic restrictions that render clinic-based rehabilitation impractical This clinical trial will recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning Eligible participants will be randomized to either 10-week 1 telephone-based GMT 2 telephone-based attention-control or 3 usual care Primary outcomes will include observed and self-reported executive functioning and self-reported functional status as measured by a battery of standardized and previously validated cognitive tests and instruments including the Delis-Kaplan Executive Function System Tower Test the Dysexecutive Questionnaire and the Functional Activities Questionnaire Secondary outcomes will consist of depressive and PTSD symptoms as measured by the Patient Health Questionnaire-9 and PTSD Checklist - Civilian Version respectively Outcome data will be collected at baseline 6 weeks after hospitalization and at 4 month treatment completion and 7 month follow-up from hospital discharge Our cognitive rehabilitation intervention will serve to broadly disseminate evidenced-based cognitive strategies to a trauma population that has difficulty returning to productive life both inside and outside the home due to profound functional and psychological disability Findings from this study will support future research to improve the cognitive functional and psychological health of patients following major trauma through innovative rehabilitation interventions and delivery methods
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H133G120052 | OTHER_GRANT | NIDRR | None |