- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01788514
Combining Entertainment & Influenza Education for Pediatric Patients
Combining Entertainment & Education Into an Age Appropriate Intervention Geared Toward Increasing Influenza Vaccination of Pediatric Patients in Underserved Communities
Study Overview
Detailed Description
Each year, during the fall and winter, coinciding with the influenza season, the number of health care visits and the number of days missed from school increases due to febrile respiratory illnesses. The highest rates of influenza infections are present amongst school-age children. The vaccination against seasonal influenza remains the most important measure to prevent infection and to combat the overall spread of the virus. School-age children, in particular, adolescents, may not be aware of the need for influenza vaccination.
Interactive computerized educational programs have been developed and used in different pediatric settings in an attempt to increase children's understanding of their medical condition, and improve adherence to the treatment.
The investigators identified one of our satellite pediatric clinics, as being the perfect venue for an intervention that will attempt to increase influenza vaccination. The clinic is located in an underserved area. More than 9,000 children are seen annually in this clinic with about 20% of the patients age 8 and above. A pediatric pulmonary office, part of the pediatric clinic, serves a high number of patients, most of whom have poorly controlled asthma.
Currently, no focused, developmentally appropriate education programs regarding vaccination are used in our outpatient clinics.
The investigators propose implementing an influenza vaccination educational program in this pediatric satellite office that serves a population that has historical low rates of influenza vaccination.
The investigators have developed an influenza-vaccination-education-study-program that will involve the use of an animated influenza vaccine-based computer program (videogame) that is designed from the investigator's own initiative. This videogame should provide a basis or foundation to discuss the need for influenza vaccination and the adverse effects of influenza disease. It will be designed to intrigue the child by providing animated tours and creative experiences that are designed to encourage behavioral changes towards the need for vaccination.
The investigators hypothesis that by using this hybrid entertainment-educational tool, we will increase children's knowledge about influenza disease and the need for influenza vaccination. By using this age appropriate intervention, we aim to decrease children and adolescent's anxiety related to the vaccination and to increase vaccination rates. The investigators hypothesis that our intervention will have a high impact since it is geared to an ethnic community with historically low rates of influenza vaccination.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Mineola, New York, United States, 11501
- Winthrop University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children 8 years of age and older
Exclusion Criteria:
- Anyone who does not voluntarily give consent or assent to this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Videogame
Subject will play educational videogame
|
Subject will play an interactive educational videogame that is designed to increase their knowledge on influenza and the influenza vaccination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increase the knowledge regarding influenza infection and influenza vaccination in school-age children and adolescents.
Time Frame: 7 months
|
Subjects will be given a pre-intervention questionnaire to assess their basic knowledge about influenza infection.
Subjects then will play a videogame, designed to be an entertainment-educational hybrid product on influenza infection and influenza vaccination subject.
After the intervention, subjects will fill out a post-intervention questionnaire that will assess their knowledge about influenza infection and vaccination.
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increase influenza vaccination in school-age children and adolescents using an entertainment-educational videogame product.
Time Frame: 7 months
|
We will assess how many subjects chose to receive the influenza vaccination after playing the educational interactive videogame.
|
7 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leonard Krilov, MD, Winthrop University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11028 (DAIDS ES Registry Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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