Telephone Intervention After Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Brain Injuries
• Interventions: Behavioral: Self-management telephone counseling

• Registration Number: NCT00483522
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2004-12
• Study First Submitted: 2007-06-05
• Study First Submitted QC: 2007-06-05
• Study First Posted: 2007-06-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 433

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Self-management telephone counseling	Scheduled telephone counseling over 2 years time.

Primary Outcome Measures

Name	Time	Method
A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being.	One and two years

Trial Locations

Locations (3)

Methodist Rehabilitation Center; 🇺🇸 Jackson, Mississippi, United States

Moss Rehabilitation Research Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Washington; 🇺🇸 Seattle, Washington, United States