Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury (TBI)
|ClinicalTrials.gov Identifier: NCT00483444|
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Brain Concussion||Behavioral: Scheduled telephone follow-up||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||366 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Telephone Follow-Up on Outcome After Mild TBI|
|Actual Study Start Date :||October 2003|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||May 2006|
No Intervention: 2
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.
Behavioral: Scheduled telephone follow-up
Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills.
- Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status [ Time Frame: Six months ]
- 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 ]
- Assess the effectiveness of this intervention in subgroups defined by gender or race. [ Time Frame: Six months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483444
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Kathleen R Bell, M.D.||University of Washington|