Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury

NCT ID: NCT00483444

Last Updated: 2017-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2006-05-31

Brief Summary

The purpose of this study is to see whether providing education and counseling after a mild traumatic brain injury will help in preventing symptoms from becoming chronic over the first six months after injury.

Detailed Description

This study examines the effect of scheduled telephone calls on the outcome after mild traumatic brain injury (MTBI) or concussion. These calls offer subjects information, focused counseling, and referrals. MTBI is extremely common in the United States, numbering well over a million cases per year. Although recovery for most is quite good, 10-20% of persons have persisting symptoms that affect employment, quality of life, and health care expenses. We are examining one means to decrease persisting symptoms by offering early, consistent intervention before symptoms become persistent.

The subjects are enrolled in the emergency departments (ED) of the hospital and receive the baseline assessment while still in the ED. Subjects are randomly assigned to two groups: Group 1 standard care and Group 2 standard care, toll-free telephone number, and scheduled telephone calls for follow-up at 1-2 days, 2, 4, 8, and 12 weeks after injury. All subjects are contacted again at 6 months for an outcome assessment that is done over the telephone.

On the telephone, subjects are asked about current problems, and are given both information about recovery from MTBI and some counseling on dealing with symptoms or other complaints. They are also given community resources to obtain assistance if needed. Telephone call are reviewed by supervisors (physician and psychologist) for adherence to protocol and for training purposes.

Conditions

Brain Concussion

Keywords

Rehabilitation; Brain injuries; Directive counseling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

2

Control group were recruited in the emergency department after concussion and received standard care as directed by the ED physician and PCP.

Group Type: NO_INTERVENTION

No interventions assigned to this group

1

Persons with concussion recruited in the emergency department received 5-6 scheduled telephone counseling calls focused on symptom management and self-management.

Group Type: EXPERIMENTAL

Scheduled telephone follow-up

Intervention Type: BEHAVIORAL

Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills.

Interventions

Scheduled telephone follow-up

Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis consistent with mild traumatic brain injury
• Glasgow Coma Scale score 13-15
• Loss of consciousness less than or = to 30 minutes
• Any period of alteration of consciousness or post-traumatic amnesia
• age between 16 and 80
• permanent address
• ability to communicate in English

Exclusion Criteria

• hospitalization within previous year for traumatic brain injury
• prior or current diagnosis of central nervous system or major psychiatric disorder
• Intoxication sufficient enough to cloud the diagnosis of mild TBI
• current alcohol dependence

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Bell

Professor, Rehabilitative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen R Bell, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18469027 (View on PubMed)

Hoffman JM, Dikmen S, Temkin N, Bell KR. Development of posttraumatic stress disorder after mild traumatic brain injury. Arch Phys Med Rehabil. 2012 Feb;93(2):287-92. doi: 10.1016/j.apmr.2011.08.041.

Reference Type: RESULT

PMID: 22289239 (View on PubMed)

Powell JM, Ferraro JV, Dikmen SS, Temkin NR, Bell KR. Accuracy of mild traumatic brain injury diagnosis. Arch Phys Med Rehabil. 2008 Aug;89(8):1550-5. doi: 10.1016/j.apmr.2007.12.035. Epub 2008 Jul 2.

Reference Type: RESULT

PMID: 18597735 (View on PubMed)

Other Identifiers

25091-G

Identifier Type: -

Identifier Source: org_study_id