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Telephone Intervention After Traumatic Brain Injury

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00483522
Enrollment
433
Registered
2007-06-07
Start date
2004-12-31
Completion date
2009-06-30
Last updated
2012-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

Keywords

Rehabilitation, Directive counseling, Brain injuries

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.

Interventions

BEHAVIORALSelf-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.

Sponsors

U.S. Department of Education
CollaboratorFED
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026