Plain English Summary
Background and study aims
Lyme disease or Lyme borreliosis (LB) is the most common disease spread by ticks both in the United States and Europe. Lyme disease is caused by a type of bacteria called Borrelia burgdorferi and is passed onto humans through the bite of infected ticks. Typical symptoms include fever, headache, fatigue (extreme tiredness), and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system. Children in particular, are at high risk of being bitten by a tick and catching LB. Currently, there is a lack of educational tools about ticks, tick bites and LB. The aim of this study is to compare the effectiveness of an online educational video game and a newly developed leaflet aimed to improve prevention of tick bites and LB among Dutch schoolchildren.
Who can participate?
Children aged between 9 and 13 who are in the final two years of a participating primary school.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group play the computer game on their personal computer. The game involves driving around their own neighbourhood and facing five risky situations where they could be bitten by a tick. The player has to avoid being bitten and give warnings to encourage others to check for ticks. The faster the warming is given, the more points the player receives. Those in the second group are given an information leaflet containing information about ticks and Lyme disease. Those in the third group do not receive any information about ticks or Lyme disease. At the start of the study and then again 4-5 months later, participants in all groups complete a number of questionnaires in order to measure their knowledge and preventative behaviour regarding tick bites and Lyme disease.
What are the possible benefits and risks of participating?
Participants benefit from learning about ticks and Lyme disease, which could help them to prevent being bitten. There are no risks associated with this study.
Where is the study run from?
25 primary schools in the Netherlands.
When is the study starting and how long is it expected to run for?
June 2012 to July 2012
Who is funding the study?
Netherlands National Institute for Public Health and the Environment (Netherlands)
Who is the main contact?
Mrs Desirée Beaujean
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Game2012
Study information
Scientific title
Education on tick bite and Lyme disease prevention, aimed at schoolchildren in the Netherlands: comparing the effects of an online video game versus a leaflet and a control group
Acronym
Study hypothesis
The aim of this study is to compare the effectiveness of an online educational video game versus a newly developed leaflet aimed to improve prevention of tick bites and Lyme disease among Dutch schoolchildren.
Ethics approval
This general survey among a sample of healthy children from the general population did not require formal medical ethical approval according to Dutch law (www.ccmo.nl/en).
Study design
Three-arm cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Lyme disease
Intervention
Children of these 25 schools were randomly assigned per class to one of three groups.
Group 1, game group: Children play the game individually on a personal computer on a single occasion. The scenario of the online educational video game www.teekcontrol.nl is that the player drives around in one’s own neighborhood (selected by entering their postal code) and is then faced with different fictive risky situations for tick bites. An example of such a risky situation is children playing in nature and picking flowers in the bushes. The player has to chase tick bite cases across a map as quickly as possible, and while doing so emit warnings that encourage people to check for ticks. The faster the warning is emitted, the more points they earn. It is possible to play the video game individually, or in a league to become the best tick controller in town. At the end of the game, the children obtain their total score.
Group 2, leaflet group: Children are given a leaflet to read, which includes information about ticks and Lyme disease.
Group 3, control group: Children receive no information.
At baseline and after the intervention (4-5 months) participants in all groups complete questionnaires to assess their knowledge and preventative behaviour regarding tick bites and Lyme disease.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Knowledge of tick bites and Lyme disease is measured using a questionnaire designed for the purpose of this study at baseline and 4-5 months later.
Secondary outcome measures
Perception and preventive behavior regarding tick bites and Lyme disease is measured using a questionnaire designed for the purpose of this study at baseline and 4-5 months later.
Overall trial start date
01/06/2012
Overall trial end date
31/07/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children aged 9-13 years
2. Attending the two final years of primary school at a participating primary school
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
200 children per arm (game, leaflet and control).
Participant exclusion criteria
No exclusion criteria
Recruitment start date
01/06/2012
Recruitment end date
31/07/2012
Locations
Countries of recruitment
Netherlands, Netherlands Antilles
Trial participating centre
Paus Johannes School
Galileïlaan 9
Spijkenisse
3204 AN
Netherlands
Trial participating centre
Basisschool Nieuwe Regentesse
Kruisdwarsstraat 6
Utrecht
3581
Netherlands
Trial participating centre
St. Antoniusschool
Opperstraat 32
Liedekerke
1770
Netherlands
Trial participating centre
Kohnstammschool
Marislaan 1
Utrecht
3582
Netherlands
Trial participating centre
Alfonsusschool
Pastoor Geertmanstraat 10
Enschede
7535
Netherlands
Trial participating centre
De Sprankel
Essink Lane 1
Grave
5361 JT
Netherlands
Trial participating centre
CBS Hoog Moersbergen
Tromplaan 1
Doorn
3941 VR
Netherlands
Trial participating centre
De Wingerd
Marnixstraat 1
Hengelo
7553
Netherlands
Trial participating centre
De Schothorst
Klaas de Rookstraat 53
Hengelo
7558 DJ
Netherlands
Trial participating centre
School met de Bijbel
Vijverhofstraat 2
Venlo
5913 TV
Netherlands
Trial participating centre
De Dagobert
Predikbroedersweg 1
Tiel
4003 AL
Netherlands
Trial participating centre
r.k. Josefschool
Sint Janskerkstraat 10-12
Culemborg
4101
Netherlands
Trial participating centre
OBS de Brink
Mijehof 302
Amsterdam-Zuidoost
1106
Netherlands
Trial participating centre
Willem-Alexanderschool
Orion 15-17
Amstelveen
1188
Netherlands
Trial participating centre
Basisschool St Theresia
Postweg 131
Barger-Compascuum
7884
Netherlands
Trial participating centre
RKPC basisschool De Toekomst
Ageommeleane 14
Bakhuizen
8574 TN
Netherlands
Trial participating centre
a.b.b.s. Us Nije Gea
Buorren 8
8185 KE
Elahuizen
Netherlands
Trial participating centre
Basisschool Nieuwe Regentesse
Kruisdwarsstraat 6
Utrecht
3581 GL
Netherlands
Trial participating centre
St. Antoniusschool
Oud-Oosteinde 2
Axel
4571 DE
Netherlands
Trial participating centre
Louise de Colignyschool
Alexander Gogelweg 65
Vlissingen
4384 EV
Netherlands
Trial participating centre
De Branding
Bouwen Ewoutstraat 51
Vlissingen
4381 PP
Netherlands
Trial participating centre
R -K basisschool de Vlieger
Eikvaren 41
Deventer
7422 NR
Netherlands
Trial participating centre
De Sprankel
Oude Wetering 80
Zwolle
8044 PA
Netherlands
Trial participating centre
CBS De Fontein
Asterstraat 1
Westerhaar
7676 BW
Netherlands
Trial participating centre
De Wierde
Suze Robertsonlaan 2
Almelo
7606 HZ
Netherlands
Sponsor information
Organisation
National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu)
Sponsor details
Antonie van Leeuwenhoek Lane 9
Bilthoven
3721
Netherlands
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Netherlands National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu)
Alternative name(s)
Netherlands National Institute for Public Health and the Environment, RIVM
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Netherlands
Results and Publications
Publication and dissemination plan
Planned publication of this study in BMC Public Health in 2016.
IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
31/12/2016
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary