InfluenzaNCT01788514
Combining Entertainment & Influenza Education for Pediatric Patients
A study testing Videogame in people with Influenza, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Videogame
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 8 years of age and older
Who cannot join
- Anyone who does not voluntarily give consent or assent to this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: Combining Entertainment & Education Into an Age Appropriate Intervention Geared Toward Increasing Influenza Vaccination of Pediatric Patients in Underserved Communities
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. The investigators propose implementing an influenza vaccination educational program in the pediatric satellite office that serves a population that has historical low rates of influenza vaccination.
Read the 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.
- Conditions
- Influenza
- Being tested
- Videogame
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideogameOther
Subject will play an interactive educational videogame that is designed to increase their knowledge on influenza and the influenza vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Videogame | Other | Subject will play educational videogame Receives: Other: Videogame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase the knowledge regarding influenza infection and influenza vaccination in school-age children and adolescents.
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.
Measured: 7 months
Secondary outcomes (1)
Increase influenza vaccination in school-age children and adolescents using an entertainment-educational videogame product.
We will assess how many subjects chose to receive the influenza vaccination after playing the educational interactive videogame.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonard Krilov, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788514
- Sponsor's protocol ID
- 11028
- Status last verified
- Feb 2019
- First submitted
- 22 Jan 2013
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Entertainment & Education Into an Age Appropriate Intervention Geared Toward Increasing Influenza Vaccination of Pediatric Patients in Underserved Communities
- ClinicalTrials.gov ID
- NCT01788514
- Acronym / sponsor ID
- 11028
- Conditions
- Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The investigators propose implementing an influenza vaccination educational program in the pediatric satellite office that serves a population that has historical low rates of influenza vaccination.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Videogame | Other | Other: VideogameSubject will play educational videogame |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 8 years of age and older
Key exclusion criteria (1 listed)
- Anyone who does not voluntarily give consent or assent to this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideogameSubject will play an interactive educational videogame that is designed to increase their knowledge on influenza and the influenza vaccination. | Other | Videogame |
Primary outcome
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.
1 secondary outcome
Increase influenza vaccination in school-age children and adolescents using an entertainment-educational videogame product.
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard Krilov, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videogame in people with Influenza, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase the knowledge regarding influenza infection and influenza vaccination in school-age children and adolescents. (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.