Telephone Intervention After Traumatic Brain Injury

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: NCT00483522
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : June 20, 2012
U.S. Department of Education
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This study seeks to determine if telephone counseling improves the outcome for persons with moderate to severe traumatic brain injury (TBI).

Condition or disease Intervention/treatment Phase
Brain Injuries Behavioral: Self-management telephone counseling Not Applicable

Detailed Description:

Subjects are recruited from the three participating TBI Model Systems of Care at Seattle, Philadelphia, and Jackson. After informed consent is obtained, some information is gathered about the injury and information about how the subject is doing cognitively, socially, and emotionally. After this information is obtained and after the subject is discharged from the acute rehabilitation unit, the subject is randomly selected to receive either standard care after discharge or standard care plus the telephone counseling.

The telephone follow-up group receives a telephone call from a research coordinator in 3-4 days, 2, 4, 8 weeks, and 5, 7, 9, 12, 15, 18, and 21 months after the date of injury. The research coordinator will work with the subject on problem-solving and self-management skills. In addition, the research coordinator will check in with a family member or friend for whom the subject has given permission to speak.

An outcome assessment is done by telephone at 12 months and 24 months after injury.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Scheduled Telephone Intervention on Outcomes After Traumatic Brain Injury
Study Start Date : December 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Scheduled telephone counseling over 2 years time.
Behavioral: Self-management telephone counseling
Subjects are contacted 7 times in year 1 after discharge from hospital rehabilitation unit and 4 times in year 2. Telephone counseling based on a self-management/problem-solving model is conducted by a research care manager.

No Intervention: 2
This control group will receive standard care after hospital rehabilitation discharge as directed by their physician.

Primary Outcome Measures :
  1. A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being. [ Time Frame: One and two years ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • a primary diagnosis of traumatic brain injury upon admission to inpatient rehabilitation
  • age 16 years or older
  • arrival to an emergency department within 24 hours of acute injury
  • receipt of both acute hospital care and inpatient rehabilitation within our facilities
  • a permanent home address

Exclusion Criteria:

  • previous hospitalization for TBI
  • acute psychiatric disorder (e.g., schizophrenia or bipolar affective disorder)
  • progressive neurological disease
  • lack of a permanent home address
  • discharge to a skilled nursing facility

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): NCT00483522

United States, Mississippi
Methodist Rehabilitation Center
Jackson, Mississippi, United States, 39216
United States, Pennsylvania
Moss Rehabilitation Research Institute
Philadelphia, Pennsylvania, United States, 19141
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
U.S. Department of Education
Principal Investigator: Kathleen R Bell, M.D. University of Washington
Study Director: Tessa Hart, Ph.D. Moss Rehabilitation Research Institute
Study Director: Mark Sherer, Ph.D. Methodist Rehabilitation Center

Publications of Results:
Other Publications:
Responsible Party: University of Washington Identifier: NCT00483522     History of Changes
Other Study ID Numbers: 98-7055-C09
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012

Keywords provided by University of Washington:
Directive counseling
Brain injuries

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