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Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury (TBI)

Primary Purpose

Brain Concussion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scheduled telephone follow-up
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion focused on measuring Rehabilitation, Brain injuries, Directive counseling

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

2

1

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 5, 2007
Last Updated
November 7, 2017
Sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00483444
Brief Title
Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury
Acronym
TBI
Official Title
The Effect of Telephone Follow-Up on Outcome After Mild TBI
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2003 (Actual)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion
Keywords
Rehabilitation, Brain injuries, Directive counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
No Intervention
Arm Description
Control group were recruited in the emergency department after concussion and received standard care as directed by the ED physician and PCP.
Arm Title
1
Arm Type
Experimental
Arm Description
Persons with concussion recruited in the emergency department received 5-6 scheduled telephone counseling calls focused on symptom management and self-management.
Intervention Type
Behavioral
Intervention Name(s)
Scheduled telephone follow-up
Intervention Description
Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills.
Primary Outcome Measure Information:
Title
Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status
Time Frame
Six months
Secondary Outcome Measure Information:
Title
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)
Time Frame
Six months
Title
Assess the effectiveness of this intervention in subgroups defined by gender or race.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen R Bell, M.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18469027
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.
Results Reference
result
PubMed Identifier
22289239
Citation
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.
Results Reference
result
PubMed Identifier
18597735
Citation
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.
Results Reference
result

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Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury

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