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Completed

NCT Number: NCT00483522

Telephone Intervention After Traumatic Brain Injury

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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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Methodist Rehabilitation Center, Jackson, Mississippi, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management telephone counseling

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jun 7, 2007
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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