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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | No Intervention | Control group were recruited in the emergency department after concussion and received standard care as directed by the ED physician and PCP. | |
| 1 | Experimental | Persons with concussion recruited in the emergency department received 5-6 scheduled telephone counseling calls focused on symptom management and self-management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scheduled telephone follow-up | Behavioral | Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status | Six months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen R Bell, M.D. | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18469027 | Result | Bell KR, Hoffman JM, Temkin NR, Powell JM, Fraser RT, Esselman PC, Barber JK, Dikmen S. The effect of telephone counselling on reducing post-traumatic symptoms after mild traumatic brain injury: a randomised trial. J Neurol Neurosurg Psychiatry. 2008 Nov;79(11):1275-81. doi: 10.1136/jnnp.2007.141762. Epub 2008 May 9. | |
| 22289239 | Result |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Six months |
| Hoffman JM, Dikmen S, Temkin N, Bell KR. Development of posttraumatic stress disorder after mild traumatic brain injury. Arch Phys Med Rehabil. 2012 Feb;93(2):287-92. doi: 10.1016/j.apmr.2011.08.041. |
| 18597735 | Result | Powell JM, Ferraro JV, Dikmen SS, Temkin NR, Bell KR. Accuracy of mild traumatic brain injury diagnosis. Arch Phys Med Rehabil. 2008 Aug;89(8):1550-5. doi: 10.1016/j.apmr.2007.12.035. Epub 2008 Jul 2. |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |