NCT00771277

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

September 18, 2014

Completed
Last Updated

April 28, 2015

Status Verified

August 1, 2014

Enrollment Period

6 months

First QC Date

October 8, 2008

Results QC Date

September 5, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

Brain InjuriesCaregiversVolunteer WorkersSocial Networks

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

EXPERIMENTAL

Use of volunteer support teams to provide services

Behavioral: Support Teams

Interventions

Support TeamsBEHAVIORAL

Use of volunteers organized into teams with a coordinator to provide services to TBI family

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Dr. Linda O. Nichols
Organization
VA Medical Center Memphis

Study Officials

  • Linda Olivia Nichols, PhD

    Memphis VA Medical Center, Memphis, TN

    PRINCIPAL INVESTIGATOR

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

Locations