Telephone Intervention After Traumatic Brain Injury

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483522
• Other study ID #: 98-7055-C09
• Status: Completed
• Phase: N/A
• First received: June 5, 2007
• Last updated: June 19, 2012
• Start date: December 2004
• Est. completion date: June 2009

Study information

• Verified date: June 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Methodist Rehabilitation Center	Jackson	Mississippi
United States	Moss Rehabilitation Research Institute	Philadelphia	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	U.S. Department of Education

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bell KR, Brockway JA, Hart T, Whyte J, Sherer M, Fraser RT, Temkin NR, Dikmen SS. Scheduled telephone intervention for traumatic brain injury: a multicenter randomized controlled trial. Arch Phys Med Rehabil. 2011 Oct;92(10):1552-60. doi: 10.1016/j.apmr.2 — View Citation

Bell KR, Esselman P, Garner MD, Doctor J, Bombardier C, Johnson K, Temkin N, Dikmen S. The use of a World Wide Web-based consultation site to provide support to telephone staff in a traumatic brain injury demonstration project. J Head Trauma Rehabil. 2003 Nov-Dec;18(6):504-11. — View Citation

Bell KR, Hoffman JM, Doctor JN, Powell JM, Esselman P, Bombardier C, Fraser R, Dikmen S. Development of a telephone follow-up program for individuals following traumatic brain injury. J Head Trauma Rehabil. 2004 Nov-Dec;19(6):502-12. — View Citation

Bell KR, Hoffman JM, Temkin NR, Powell JM, Fraser RT, Esselman PC, Barber JK, Dikmen S. The effect of telephone counselling on reducing post-traumatic symptoms after mild traumatic brain injury: a randomised trial. J Neurol Neurosurg Psychiatry. 2008 Nov;79(11):1275-81. doi: 10.1136/jnnp.2007.141762. Epub 2008 May 9. — View Citation

Bell KR, Temkin NR, Esselman PC, Doctor JN, Bombardier CH, Fraser RT, Hoffman JM, Powell JM, Dikmen S. The effect of a scheduled telephone intervention on outcome after moderate to severe traumatic brain injury: a randomized trial. Arch Phys Med Rehabil. 2005 May;86(5):851-6. — View Citation

Bombardier CH, Bell KR, Temkin NR, Fann JR, Hoffman J, Dikmen S. The efficacy of a scheduled telephone intervention for ameliorating depressive symptoms during the first year after traumatic brain injury. J Head Trauma Rehabil. 2009 Jul-Aug;24(4):230-8. doi: 10.1097/HTR.0b013e3181ad65f0. — View Citation

Hart T, Sherer M, Temkin N, Whyte J, Dikmen S, Heinemann AW, Bell K. Participant-proxy agreement on objective and subjective aspects of societal participation following traumatic brain injury. J Head Trauma Rehabil. 2010 Sep-Oct;25(5):339-48. doi: 10.1097 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being.		One and two years	No