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Telephone Intervention After Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00483522
First received: June 5, 2007
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention
Brain Injuries
 Behavioral: Self-management telephone counseling

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 Scheduled Telephone Intervention on Outcomes After Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 433
Study Start Date: December 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483522

Locations
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
Investigators
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
  More Information

Publications:

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00483522     History of Changes
Other Study ID Numbers: 98-7055-C09
Study First Received: June 5, 2007
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013