NCT00483444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

June 5, 2007

Last Update Submit

November 7, 2017

Conditions

Brain Concussion

Keywords

RehabilitationBrain injuriesDirective counseling

Outcome Measures

Primary Outcomes (1)

  • Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status

    Six months

Secondary Outcomes (2)

  • 1. Improvement of functional level, emotional status, community activities, and perceived quality of life (SF-12 Health Survey, Patient Health Questionnaire - Depression and Anxiety Scales, Community Integration Scale, Perceived Quality of Life)

    Six months

  • Assess the effectiveness of this intervention in subgroups defined by gender or race.

    Six months

Study Arms (2)

2

NO INTERVENTION

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

1

EXPERIMENTAL

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

Behavioral: Scheduled telephone follow-up

Interventions

Scheduled telephone follow-upBEHAVIORAL

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

1

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

  • 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: 18469027RESULT

  • 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.

    PMID: 22289239RESULT

  • 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.

    PMID: 18597735RESULT

MeSH Terms

Conditions

Brain ConcussionBrain Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Kathleen R Bell, M.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Professor, Rehabilitative Medicine

Study Record Dates

First Submitted

June 5, 2007

First Posted

June 7, 2007

Study Start

October 1, 2003

Primary Completion

February 1, 2006

Study Completion

May 1, 2006

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations

US(1)