Team Based Initiative Support
1 other identifier
interventional
6
1 country
1
Brief Summary
Traumatic brain injury (TBI) has been called the signature injury of the Iraq War. This pilot study investigated family needs of 6 rural families caring for a Veteran with TBI. Two Veterans had moderate TBI and all had comorbid post traumatic stress disorder diagnoses. The veterans were 1 to 5 years post-injury. Families were reluctant to include others in helping the family because of privacy concerns, desire for independence, and negative employment repercussions if the extent of the TBI deficit became known in the community. Most were still employed, despite TBI deficits. Despite having previously received information, families still had substantial needs for information about the condition and its prognosis and sequelae (e.g., why things happen, unsafe/frightening behaviors, work, finances, communication changes) and the availability and types of services (e.g., who to contact, benefits, help needed)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 8, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
September 18, 2014
CompletedApril 28, 2015
August 1, 2014
6 months
October 8, 2008
September 5, 2014
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Reported 5 Themes
Six caregivers of TBI patients were interviewed; responses were transcribed and coded; inter-rater agreement was calculated. Themes were lack of understanding about TBI and its long-term effects and the differences between TBI and PTSD, privacy concerns, independence, fear of negative employment/financial repercussions, and difficulty in interactions with the Department of Defense (DoD) and the Department of Veterans Affairs (VA)
collected over 3 interviews of approximately 1 hour each
Secondary Outcomes (2)
PHQ-9
baseline
Zarit Burden Inventory
baseline
Study Arms (1)
Arm 1
EXPERIMENTALUse of volunteer support teams to provide services
Interventions
Use of volunteers organized into teams with a coordinator to provide services to TBI family
Eligibility Criteria
You may qualify if:
- The primary family member caregiver of the Traumatic Brain Injury (TBI) veteran
- Veteran receiving care at the Memphis Veterans Affairs Medical Center
- Perceived need of help and support
- Willing to participate in the study after discussion with OEF/OIF Program
- Manager or team member
You may not qualify if:
- \- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, 38104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Linda O. Nichols
- Organization
- VA Medical Center Memphis
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Olivia Nichols, PhD
Memphis VA Medical Center, Memphis, TN
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2008
First Posted
October 13, 2008
Study Start
September 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
April 28, 2015
Results First Posted
September 18, 2014
Record last verified: 2014-08