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Telephone Intervention After Traumatic Brain Injury

Primary Purpose

Brain Injuries

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

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • Methodist Rehabilitation Center
  • Moss Rehabilitation Research Institute
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Scheduled telephone counseling over 2 years time.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 5, 2007
Last Updated
June 19, 2012
Sponsor
University of Washington
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT00483522
Brief Title
Telephone Intervention After Traumatic Brain Injury
Official Title
The Effect of Scheduled Telephone Intervention on Outcomes After Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Scheduled telephone counseling over 2 years time.
Arm Title
2
Arm Type
No Intervention
Arm Description
This control group will receive standard care after hospital rehabilitation discharge as directed by their physician.
Intervention Type
Behavioral
Intervention Name(s)
Self-management telephone counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being.
Time Frame
One and two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
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
First Name & Middle Initial & Last Name & Degree
Tessa Hart, Ph.D.
Organizational Affiliation
Moss Rehabilitation Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark Sherer, Ph.D.
Organizational Affiliation
Methodist Rehabilitation Center
Official's Role
Study Director
Facility Information:
Facility Name
Methodist Rehabilitation Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Moss Rehabilitation Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14707880
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.
Results Reference
background
PubMed Identifier
15602312
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.
Results Reference
background
PubMed Identifier
15895327
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.
Results Reference
background
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
background
PubMed Identifier
19625862
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.
Results Reference
background
PubMed Identifier
20042981
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.
Results Reference
result
PubMed Identifier
21963122
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.
Results Reference
result

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Telephone Intervention After Traumatic Brain Injury

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