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

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00483444
First received: June 5, 2007
Last updated: June 2, 2008
Last verified: June 2008
History of Changes
  Purpose

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 Intervention
Brain Concussion
 Behavioral: Scheduled telephone follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Telephone Follow-Up on Outcome After Mild TBI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 366
Study Start Date: October 2003
Study Completion Date: August 2006
Arms Assigned Interventions
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.
 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.
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.

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

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483444

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

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kathleen R. Bell/Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00483444     History of Changes
Other Study ID Numbers: 03-9639-G
Study First Received: June 5, 2007
Last Updated: June 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Rehabilitation
Brain injuries
Directive counseling

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

ClinicalTrials.gov processed this record on May 16, 2013