Clinical Trial: Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of Telephone Follow-Up on Outcome After Mild TBI
Brief Summary: The purpose of this study is to see whether providing education and counseling after a mild traumatic brain injury will help in preventing symptoms from becoming chronic over the first six months after injury.
Detailed Summary:
This study examines the effect of scheduled telephone calls on the outcome after mild traumatic brain injury (MTBI) or concussion. These calls offer subjects information, focused counseling, and referrals. MTBI is extremely common in the United States, numbering well over a million cases per year. Although recovery for most is quite good, 10-20% of persons have persisting symptoms that affect employment, quality of life, and health care expenses. We are examining one means to decrease persisting symptoms by offering early, consistent intervention before symptoms become persistent.
The subjects are enrolled in the emergency departments (ED) of the hospital and receive the baseline assessment while still in the ED. Subjects are randomly assigned to two groups: Group 1 standard care and Group 2 standard care, toll-free telephone number, and scheduled telephone calls for follow-up at 1-2 days, 2, 4, 8, and 12 weeks after injury. All subjects are contacted again at 6 months for an outcome assessment that is done over the telephone.
On the telephone, subjects are asked about current problems, and are given both information about recovery from MTBI and some counseling on dealing with symptoms or other complaints. They are also given community resources to obtain assistance if needed. Telephone call are reviewed by supervisors (physician and psychologist) for adherence to protocol and for training purposes.
Sponsor: University of Washington
Current Primary Outcome: Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status [ Time Frame: Six months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 1. Improvement of functional level, emotional status, community activities, and perceived quality of life (SF-12 Health Survey, Patient Health Questionnaire - Depression and Anxiety Scales, Community Integration Scale, Perceived Quality of Life) [ Time Frame: Six months ]
- Assess the effectiveness of this intervention in subgroups defined by gender or race. [ Time Frame: Six months ]
Original Secondary Outcome: Same as current
Information By: University of Washington
Dates:
Date Received: June 5, 2007
Date Started: October 2003
Date Completion:
Last Updated: February 2, 2017
Last Verified: February 2017
