Telephone Intervention After Traumatic Brain Injury

NCT00483522 | Completed

• 1 other identifier: 98-7055-C09
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Brain Injuries

Keywords

Rehabilitation; Directive counseling; Brain injuries

Outcome Measures

Primary Outcomes (1)

• A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being.

  One and two years

Study Arms (2)

1

EXPERIMENTAL

Scheduled telephone counseling over 2 years time.

Behavioral: Self-management telephone counseling

2

NO INTERVENTION

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

Interventions

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.

1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• U.S. Department of Education: collaborator

Study Sites (3)

Methodist Rehabilitation Center

Jackson, Mississippi, 39216, United States

Location

Moss Rehabilitation Research Institute

Philadelphia, Pennsylvania, 19141, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (7)

• 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. doi: 10.1097/00001199-200311000-00004.

  PMID: 14707880 BACKGROUND

• 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. doi: 10.1097/00001199-200411000-00007.

  PMID: 15602312 BACKGROUND

• 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. doi: 10.1016/j.apmr.2004.09.015.

  PMID: 15895327 BACKGROUND

• 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.

  PMID: 18469027 BACKGROUND

• 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.

  PMID: 19625862 BACKGROUND

• 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/HTR.0b013e3181c7e60b.

  PMID: 20042981 RESULT

• 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.2011.05.018.

  PMID: 21963122 RESULT

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kathleen R Bell, M.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

• Tessa Hart, Ph.D.

  Moss Rehabilitation Research Institute

  STUDY DIRECTOR

• Mark Sherer, Ph.D.

  Methodist Rehabilitation Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 7, 2007
• Study Start: December 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

US (3)