Condition category
Infections and Infestations
Date applied
17/10/2016
Date assigned
21/10/2016
Last edited
21/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mrs Desiree Beaujean

ORCID ID

Contact details

National Institute for Health and Environment (Rijksinstituut voor Volksgezondheid en Milieu)
Antonie van Leeuwenhoek Lane 9
Bilthoven
3721
Netherlands

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

www.rivm.nl

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

Publication citations

Additional files

Editorial Notes