Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Telephone Follow-Up on Outcome After Mild TBI

Conditions
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Brain Concussion

Intervention / Treatment
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* Behavioral: Scheduled telephone follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2<br>Control group were recruited in the emergency department after concussion and received standard care as directed by the ED physician and PCP. | |
| Experimental: 1<br>Persons with concussion recruited in the emergency department received 5-6 scheduled telephone counseling calls focused on symptom management and self-management. | Behavioral: Scheduled telephone follow-up<br>* Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Brain injuries, Directive counseling