Telephone Intervention After Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

433 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Brain Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Scheduled telephone counseling over 2 years time.

Group Type EXPERIMENTAL

Self-management telephone counseling

Intervention Type BEHAVIORAL

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.

2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No