Team Based Initiative Support

• ClinicalTrials.gov Identifier: NCT00771277
• Recruitment Status: Completed
• First Posted: October 13, 2008
• Results First Posted: September 18, 2014
• Last Update Posted: April 28, 2015
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Traumatic Brain Injury	Behavioral: Support Teams	Not Applicable

Detailed Description:

Background/Rationale: Traumatic brain injury (TBI) has been called the signature injury of the Iraq War. This pilot study was an investigation of the feasibility of volunteer support teams for families providing care to a returning Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) veteran with TBI. Volunteer support teams coordinate tasks and effort for family and volunteers. This support model is particularly relevant for families in rural areas that are likely to be under-funded in home and community services.

Objectives: The original study objective was to determine feasibility of, and barriers to, implementing volunteer support teams with rural families of OEF/OIF veterans with recently diagnosed moderate-severe TBI. A secondary objective was to provide information on TBI to families and volunteers.

Methodology: The project coach met the family in the home to identify unmet needs and to determine availability of family and friends who could help meet needs. The coach provided training about TBI and a Resource Book with information on TBI diagnosis, prognosis, and symptoms. There were baseline, monthly, and study end qualitative interviews with the family focusing on concerns.

Findings/Result: Fifteen families were referred; TBI levels were mainly mild. Six families were enrolled. Two Veterans had moderate TBI and all had comorbid post traumatic stress disorder diagnoses. All lived in rural communities. The veterans were 1 to 5 years post-injury and support systems were already in place, although these systems were small. Families did not want to implement caregiving teams 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. However, the project identified that families 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). Families often reported feeling lost in negotiating the DoD and VA systems.

Impact: Issues and concerns for rural, mild TBI veterans and their families were identified. Families and the Veteran may not be ready to accept the diagnosis when it first occurs. Families and the veteran identified a need for just-in-time information on TBI, its consequences, and services available. The delicate balance between return to full functioning as a community member and the deficits of TBI is threatened by family independence, privacy needs, and fear of loss of employment. The study identified opportunities for community education and for coordination between the military and VHA.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Team Based Initiative Support
• Study Start Date: September 2008
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1; Use of volunteer support teams to provide services	Behavioral: Support Teams; Use of volunteers organized into teams with a coordinator to provide services to TBI family

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Reported 5 Themes [ Time Frame: collected over 3 interviews of approximately 1 hour each ]
   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)

Secondary Outcome Measures :

1. PHQ-9 [ Time Frame: baseline ]
   The Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001) assesses caregiver depression and anxiety on a scale from not at all (0) to nearly every day (3), with higher total scores indicating greater symptoms. Scores range from 0-27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression respectively.
2. Zarit Burden Inventory [ Time Frame: baseline ]
   Caregiver burden, as measured by the 12-item Zarit Burden Interview (Bédard et al., 2001; Zarit, Reever, & Bach-Peterson J, 1980). Burden includes concepts such as lack of time because of care, strain, restriction of life, etc. Items are scored from never (0) to nearly always (4), and higher total scores indicate greater burden. Total scores range from 0 to 88.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

- None

Contacts and Locations

Locations

United States, Tennessee

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, United States, 38104

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

• Principal Investigator: Linda Olivia Nichols, PhD; Memphis VA Medical Center, Memphis, TN

More Information

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00771277
• Other Study ID Numbers: RRP 08-383
• First Posted: October 13, 2008
• Results First Posted: September 18, 2014
• Last Update Posted: April 28, 2015
• Last Verified: August 2014

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

Brain Injuries; Caregivers; Volunteer Workers; Social Networks

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries