The Effect of Telephone Follow-Up on Outcome After Mild TBI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Concussion
- Sponsor
- University of Washington
- Enrollment
- 366
- Locations
- 1
- Primary Endpoint
- Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 Description
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.
Investigators
Kathleen Bell
Professor, Rehabilitative Medicine
University of Washington
Eligibility Criteria
Inclusion Criteria
- •Diagnosis consistent with mild traumatic brain injury
- •Glasgow Coma Scale score 13-15
- •Loss of consciousness less than or = to 30 minutes
- •Any period of alteration of consciousness or post-traumatic amnesia
- •age between 16 and 80
- •permanent address
- •ability to communicate in English
Exclusion Criteria
- •hospitalization within previous year for traumatic brain injury
- •prior or current diagnosis of central nervous system or major psychiatric disorder
- •Intoxication sufficient enough to cloud the diagnosis of mild TBI
- •current alcohol dependence
Outcomes
Primary Outcomes
Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status
Time Frame: Six months
Secondary Outcomes
- 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)(Six months)
- Assess the effectiveness of this intervention in subgroups defined by gender or race.(Six months)