Skip to content

Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury

The Effect of Telephone Follow-Up on Outcome After Mild TBI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00483444
Acronym
TBI
Enrollment
366
Registered
2007-06-07
Start date
2003-10-31
Completion date
2006-05-31
Last updated
2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Concussion

Keywords

Rehabilitation, Brain injuries, Directive counseling

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.

Interventions

BEHAVIORALScheduled telephone follow-up

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

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health statusSix months

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026