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Clinical Trials/NCT00483522
NCT00483522
Completed
N/A

The Effect of Scheduled Telephone Intervention on Outcomes After Traumatic Brain Injury

University of Washington3 sites in 1 country433 target enrollmentDecember 2004
ConditionsBrain Injuries

Overview

Phase
N/A
Intervention
Not specified
Conditions
Brain Injuries
Sponsor
University of Washington
Enrollment
433
Locations
3
Primary Endpoint
A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being.
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
June 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (3)

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