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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00483444
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : November 9, 2017
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Kathleen Bell, University of Washington

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.

Condition or disease Intervention/treatment Phase
Brain Concussion Behavioral: Scheduled telephone follow-up Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Telephone Follow-Up on Outcome After Mild TBI
Actual Study Start Date : October 2003
Actual Primary Completion Date : February 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Concussion

Arm Intervention/treatment
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.
Experimental: 1
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
Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills.

Primary Outcome Measures :
  1. Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Assess the effectiveness of this intervention in subgroups defined by gender or race. [ Time Frame: Six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00483444

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Centers for Disease Control and Prevention
Principal Investigator: Kathleen R Bell, M.D. University of Washington

Publications of Results:
Responsible Party: Kathleen Bell, Professor, Rehabilitative Medicine, University of Washington Identifier: NCT00483444     History of Changes
Other Study ID Numbers: 25091-G
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

Keywords provided by Kathleen Bell, University of Washington:
Brain injuries
Directive counseling

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating