Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury (TBI)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00483444
First received: June 5, 2007
Last updated: June 2, 2008
Last verified: June 2008

June 5, 2007
June 2, 2008
October 2003
Not Provided
Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status [ Time Frame: Six months ] [ Designated as safety issue: No ]
Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status [ Time Frame: Six months ]
Complete list of historical versions of study NCT00483444 on ClinicalTrials.gov Archive Site
  • 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) [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Assess the effectiveness of this intervention in subgroups defined by gender or race. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Six months ]
  • Assess the effectiveness of this intervention in subgroups defined by gender or race. [ Time Frame: Six months ]
Not Provided
Not Provided
 
Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury
The Effect of Telephone Follow-Up on Outcome After Mild TBI

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Brain Concussion
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.
  • No Intervention: 2
    Control group were recruited in the emergency department after concussion and received standard care as directed by the ED physician and PCP.
    Intervention: Behavioral: Scheduled telephone follow-up
  • Experimental: 1
    Persons with concussion recruited in the emergency department received 5-6 scheduled telephone counseling calls focused on symptom management and self-management.
    Intervention: Behavioral: Scheduled telephone follow-up
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. Epub 2008 May 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
366
August 2006
Not Provided

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
Both
16 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00483444
03-9639-G
No
Kathleen R. Bell/Principal Investigator, University of Washington
University of Washington
Centers for Disease Control and Prevention
Principal Investigator: Kathleen R Bell, M.D. University of Washington
University of Washington
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP