Telephone Intervention After Traumatic Brain Injury
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Scheduled Telephone Intervention on Outcomes After Traumatic Brain Injury|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Scheduled telephone counseling over 2 years time.
Behavioral: Self-management telephone counseling
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.
No Intervention: 2
This control group will receive standard care after hospital rehabilitation discharge as directed by their physician.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483522
|United States, Mississippi|
|Methodist Rehabilitation Center|
|Jackson, Mississippi, United States, 39216|
|United States, Pennsylvania|
|Moss Rehabilitation Research Institute|
|Philadelphia, Pennsylvania, United States, 19141|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Kathleen R Bell, M.D.||University of Washington|
|Study Director:||Tessa Hart, Ph.D.||Moss Rehabilitation Research Institute|
|Study Director:||Mark Sherer, Ph.D.||Methodist Rehabilitation Center|