Clinical trial NCT00483444: Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury
Official title: The Effect of Telephone Follow-Up on Outcome After Mild TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Keywords: Rehabilitation
Brain injuries
Directive counseling
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2007-06-07
Enrollment: 366
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status
timeFrame: Six months
Secondary outcomes:
measure: 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)
timeFrame: Six months
measure: Assess the effectiveness of this intervention in subgroups defined by gender or race.
timeFrame: Six months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kathleen R Bell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.