Study Title:
A New Measure of Subjective Fatigue in Individuals with Traumatic Brain Injury
Introduction:
Fatigue (a feeling like you are often physically and/or mentally exhausted) is an issue for many people who have had a traumatic brain injury (TBI). Our previous research into health related issues after brain injury have shown that fatigue is related to problems with emotional, social participation, physical/fatigue, and cognitive or thinking challenges.
Purpose of this Study:
The goal of this study is to evaluate a newly developed TBI-related fatigue questionnaire.
What Happens During this Study:
After an initial collection of demographic information is complete, you will be asked to participate in one interview (that will involve several assessments or questionnaires). The demographic information collected will include things like age, education level, living and working status, and medical history. The initial collection of demographic information, which may be done at Santa Clara Valley Medical Center or by telephone, will be followed by the interview. Each interview is approximately 1 hour long and may be done at your convenience. The interview is made up of multiple choice questions related to fatigue and other health-related quality of life areas.
Compensation:
You will be paid $25 for participating in the interview.
Potential Risks and Discomfort:
There are no known risks associated with your participation in this study. Discomfort may be experienced only to the extent that some of the questions may be of a more personal nature and that the interview may require up to 60 minutes of your time.
You may withdraw at any time.
Who is Eligible to Participate:
You must have had a traumatic brain injury (i.e. hit on the head, concussion, knocked out) that required you to seek medical attention. Mild, Moderate and Severe Injuries are all included in this study. Further, you need to wait at least six months after your brain injury to start this study. You must be 18 years or older. You need to be able to understand and communicate in English. You must be able to provide documentation of your injury. Informed consent and HIPPA forms will be mailed to you to complete.
Who is Sponsoring this Study:
The National Institute on Disability and Rehabilitation Research, U.S. Department of Education.
Who is Responsible for this Study:
Jeffrey Englander, MD
Santa Clara Valley Medical Center
Whom Do I Contact If I’m Interested in Participating:
Paul Carufel (408) 793-6431 or (800) 352-1956
paul.carufel@hhs.sccgov.org
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