Trial Outcomes & Findings for Team Based Initiative Support (NCT NCT00771277)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

collected over 3 interviews of approximately 1 hour each

Results posted on

2015-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Use of volunteer support teams to provide services Support Teams: Use of volunteers organized into teams with a coordinator to provide services to TBI family
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Team Based Initiative Support

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=6 Participants Family experience of concerns and providing support to TBI patient
Age, Continuous	45.3 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Relationship to patients wife	4 participants n=5 Participants
Relationship to patients husband	1 participants n=5 Participants
Relationship to patients grandmother	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	TBI Caregivers n=6 Participants Family caregivers providing support to TBI patients.
Number of Participants Who Reported 5 Themes Lack of information and need for information	6 participants
Number of Participants Who Reported 5 Themes Privacy concerns	6 participants
Number of Participants Who Reported 5 Themes Independence of family	6 participants
Number of Participants Who Reported 5 Themes fear of negative employment/financial repercussion	6 participants
Number of Participants Who Reported 5 Themes difficulty in interactions with DoD and VA	6 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TBI Caregivers n=6 Participants Family caregivers providing support to TBI patients.
PHQ-9	11.5 units on a scale Standard Deviation 6.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TBI Caregivers n=6 Participants Family caregivers providing support to TBI patients.
Zarit Burden Inventory	23.0 units on a scale Standard Deviation 6.7

Adverse Events

TBI Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Linda O. Nichols

VA Medical Center Memphis

Phone: 901 523-8990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place