A Phase 1 interventional study of education intervention in Focus of Study: Bicycle Helmet Wearing Compliance, sponsored by Augusta University. Completed at 1 site in United States. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-21.
Sponsored by Augusta University · Phase 1, Interventional, and Prevention
The hypothesis was that the implementation of a Safe Kids East Central brain injury prevention program targeting children and caregivers admitted to the Georgia Health Sciences University Children's Medical Center is feasible and that short-term treatment effects of injury prevention education on the child or adolescent and the caregiver will increase bicycle helmet use.
The overarching goal of this project is to reduce traumatic brain injury in children and adolescents by promoting bicycle helmet use via an inpatient educational program. The Safe Kids East Central injury prevention educational program was customized for hospitalized subjects and their caregivers. The investigators hypothesized that this program would increase bicycle helmet use.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 120 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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Inclusion Criteria:
The intervention delivered education about the benefits of bicycle helmet use and safety and was designed to be sensitive to the age and educational level of the study participant.
Behavioral: education intervention
Printed materials were given to the control group, along with a helmet for each participant.
The brain injury prevention education intervention included case scenarios as well as education about the benefits of bicycle helmet use. The intervention was designed to be sensitive to the age and educational level of the study participant and his or her parents. Educational materials were chosen to provide use of the five senses to enhance the learning experience. The intervention took place in the privacy of the patient's hospital room. The study was designed so as not to interfere with the hospital standard of care. The proper way to fit the bicycle helmet was demonstrated.
parental report of bicycle helmet use
A series of mixed model univariate analyses were used to determine group differences across the follow-ups on helmet wearing.
Time frame: change for baseline in bicycle helmet wearing at 1 and 3 months
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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