Telephone Intervention After Traumatic Brain Injury

University of Washington

Status: Completed

Conditions: Brain Injuries

Treatments: Behavioral: Self-management telephone counseling

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00483522

98-7055-C09

Details and patient eligibility

About

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

Full 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.

Enrollment: 433 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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433 participants in 2 patient groups

1

Experimental group

Description:

Scheduled telephone counseling over 2 years time.

Treatment:

Behavioral: Self-management telephone counseling

2

No Intervention group

Description:

This control group will receive standard care after hospital rehabilitation discharge as directed by their physician.