Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury

Brain Concussion Clinical Trial

— TBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483444
• Other study ID #: 25091-G
• Status: Completed
• Phase: N/A
• First received: June 5, 2007
• Last updated: November 7, 2017
• Start date: October 2003
• Est. completion date: May 2006

Study information

• Verified date: November 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: May 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion

Intervention

Behavioral:
• Scheduled telephone follow-up
Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (3)

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; — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status		Six months
Secondary	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
Secondary	Assess the effectiveness of this intervention in subgroups defined by gender or race.		Six months