Clinical trial NCT00483522: Telephone Intervention After Traumatic Brain Injury
Official title: The Effect of Scheduled Telephone Intervention on Outcomes After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Keywords: Rehabilitation
Directive counseling
Brain injuries
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2007-06-07
Enrollment: 433
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being.
timeFrame: One and two years
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Methodist Rehabilitation Center
state: Mississippi
city: Philadelphia
country: United States
facility: Moss Rehabilitation Research Institute
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kathleen R Bell, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Moss Rehabilitation Research Institute
name: Tessa Hart, Ph.D.
role: STUDY_DIRECTOR
affiliation: Methodist Rehabilitation Center
name: Mark Sherer, Ph.D.
role: STUDY_DIRECTOR
References:
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. doi: 10.1097/00001199-200311000-00004.
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. doi: 10.1097/00001199-200411000-00007.
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. doi: 10.1016/j.apmr.2004.09.015.
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.
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.
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/HTR.0b013e3181c7e60b.
citation: 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.