Telephone Intervention After Traumatic Brain Injury

Study Overview
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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).

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.

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

Conditions
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Brain Injuries

Intervention / Treatment
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* Behavioral: Self-management telephone counseling


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Scheduled telephone counseling over 2 years time. | Behavioral: Self-management telephone counseling<br>* 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.<br>|
| No Intervention: 2<br>This control group will receive standard care after hospital rehabilitation discharge as directed by their physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being. |  | One and two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Directive counseling, Brain injuries