Sexually Transmitted DiseasesNCT02128620
A Randomized Online Health Experiment for a Safer Youth Sexual Behaviour
A study testing Game-Based Appointment System in people with Sexually Transmitted Diseases and Chlamydia Trachomatis, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The objective of this project is to assess the impact of a Game-Based Appointment System on both, the clinical settings, and on the use of the educational web app www.sjekkdeg.no. An A/B testing methodology will be used. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, Chlamydia Trachomatis
- What is being tested?
- Game-Based Appointment System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 996 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to Dec 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All the users reaching voluntarily the web app www.sjekkdeg.no and answering "Yes" to the question "Are you from Tromsø?" will be included in the study.
Who cannot join
- All the users reaching voluntarily the web app www.sjekkdeg.no and answering "No" to the question "Are you from Tromsø?" will not be included in the study; however, they will be allowed to surf the website.
Trial locations and contacts
1 site in 1 country.
Norway1 site
NST-Norwegian Center for Integrated Care and Telemedicine; University Hospital of North Norway
Tromsø, 9019
About this study
Official title: Study on Sexually Transmitted Diseases Prevention - Introduction of a Novel Game-based Appointment System for Youth
The objective of this project is to assess the impact of a Game-Based Appointment System on both, the clinical settings, and on the use of the educational web app www.sjekkdeg.no.
An A/B testing methodology will be used. This methodology consist on the redirection of the users to two different versions of the website, and therefore allows to assess the interactivity of the users according to the design of the webpage and determine which one has a higher impact on the clinical settings, and consequently on prevention of STDs.
Read more
For the A/B test we will test the interactivity of two versions of a web page www.sjekkdeg.no: the A version (control), consisting en the educative web app; and the B version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment System.
The Game-Based Appointment System will offer the users the option of booking appointments at the venereology department at the University Hospital of North Norway. The system will include an automatic priority appointments function, with three levels of prioritization (triage): 1) Emergency-appointment: The user should go to the doctor on the same day or the following day. 2) Haste-appointment: Within 3-4 days; or 3) Routine-appointment: within 2-3 weeks.
The hypotheses of this research project are:
- The number of visits with the health professionals will be larger in the game-based appointment group than in the control group.
- The number of visits to the educative components of www.sjekkdeg.no will increase after the launch of the Game-Based Appointment System functionality.
- The number of visits to the educative components of www.sjekkdeg.no will be larger in the appointment group than in the control group.
- The time spent per visit to the website will be larger in the appointment group than in the control group, meaning a higher exposure to health information.
- The visitors returning rate is larger in the appointment group than in the control group.
Read the detailed description
- Compliance with strategic documents: This project is in line with recommendations made by the Norwegian Public Health Authorities, that state that ìchange of sexual practice, i.e., increased used of condoms and fewer partners, will be the main focus of containment (of sexually transmitted diseases).
- Relevance to society: The premise guiding the development of the Game-Based Appointment System is that Information and Communication Technology may facilitate the access to health services to youth regarding sexual health and prevention of sexually transmitted diseases, as well as increase their exposure in an educative environment. Early triage of health service consumers is now more and more used as an effective way to reduce expenses and the use of healthcare staff resources.
- Environmental perspectives: The project will provide a health related social network aimed at empowering the citizens to better understand and prevent sexually transmitted diseases, therefore minimizing the number of travels to visit the doctor at the healthcare service.
- Ethical aspects: The research activities will strictly follow the regulations provided by the Health Register Act (Helseregisterloven) and the Health Personnel Act (Helsepersonelloven). Both acts (with accompanying regulations) being supervised by the Ministry of Health and the Norwegian Board of Health. To guarantee approval regarding any possible use of data in a personal way, this project will pursue conformance to the regulations of the Personal Data Act (based on the European Data Protection Directive). The Personal Data act and other relevant acts and regulations are enforced and supervised by the Norwegian Data Inspectorate (Datatilsynet).
- Gender equality and gender perspectives: The planning of the this research project has stressed that the selection of participants and the conduct of the trial will all be gender-neutral.
- Being tested
- Game-Based Appointment System
- Keywords
- Sexually transmitted diseases, Internet, Education, Appointments and Schedules
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-Based Appointment SystemBehavioural
Users randomized to the www.sjekkdeg.no B version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment System
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Users randomized to the www.sjekkdeg.no A version, consisting en the educative web app, not including the Game-Based Appointment System |
| Intervention Group | Experimental | Users randomized to the www.sjekkdeg.no B version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment System Receives: Behavioral: Game-Based Appointment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the Game-Appointment System on the number of consultancies of sexually transmitted diseases with the health professionals in Tromso.
To assess if the Game-Based Appointment System increase the number of consultancies on sexually transmitted diseases with the health professionals in Tromsø, we will analyse the total number of appointments booked through the Game-Based Appointment System after 1 year of the start of the project. And we will compare the total number of sexually transmitted diseases consultancies in all health professionals Tromsø with a reference number ranging from 1000 to 1999 (Group A) versus total number of consultancies with codes ranging between 2000 and 2999 (Group B).
Measured: After one year of the launch of the Game-Based Appointment System.
Secondary outcomes (1)
Impact of the Game-Based Appointment System on the number of visits to the educative components of the web app www.sjekkdeg.no, and its utilisation.
To assess if the launch of the Game-Based Appointment System increase the number of visits to the educative component of the app www.sjekkdeg.no we will analyse and compare the absolute number and per cent of visits (new visitors and returning visitors) of users in Group A versus Group B after 1 year of the start of the project. The total number of visitors as well as the number of news and returning visitors in both versions of web app and every of its components will be tracked through Google Analytics.
To assess the impact of the launch of the Game-Based Appointment System on the utilisation of the web app www.sjekkdeg.no, we will analyse and compare the total and average time spent on the web app and in every educative component of users in Group A versus Group B after 1 year of the start of the project. The total time spent in both versions of the web app as well as the average time spent on every of its components will be tracked through Google Analytics.
Measured: After one year of the launch of the Game-Based Appointment System.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 996 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord
- Responsible party
- Principal investigator, Elia Gabarron, University Hospital of North Norway
- Investigators
- Elia Gabarron, MsC, Psych, Principal investigator, NST-Norwegian Center for Integrated Care and Telemedicine; University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128620
- Sponsor's protocol ID
- NST-40656
- Status last verified
- Jan 2016
- First submitted
- 29 Apr 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gabarron E, Serrano JA, Wynn R, Armayones M. Avatars using computer/smartphone mediated communication and social networking in prevention of sexually transmitted diseases among North-Norwegian youngsters. BMC Med Inform Decis Mak. 2012 Oct 30;12:120. doi: 10.1186/1472-6947-12-120.
PubMed 23110684Gabarron E, Schopf T, Serrano JA, Fernandez-Luque L, Dorronzoro E. Gamification strategy on prevention of STDs for youth. Stud Health Technol Inform. 2013;192:1066.
PubMed 23920840Gabarron E, Serrano JA, Fernandez-Luque L, Wynn R, Schopf T. Randomized trial of a novel game-based appointment system for a university hospital venereology unit: study protocol. BMC Med Inform Decis Mak. 2015 Apr 8;15:23. doi: 10.1186/s12911-015-0143-9.
PubMed 25890283
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Sexually Transmitted Diseases Prevention - Introduction of a Novel Game-based Appointment System for Youth
- ClinicalTrials.gov ID
- NCT02128620
- Acronym / sponsor ID
- NST-40656
- Keywords
- Sexually transmitted diseases, Internet, Education, Appointments and Schedules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 996 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Helse Nord
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 May 2014 (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 objective of this project is to assess the impact of a Game-Based Appointment System on both, the clinical settings, and on the use of the educational web app www.sjekkdeg.no.
An A/B testing methodology will be used. This methodology consist on the redirection of the users to two different versions of the website, and therefore allows to assess the interactivity of the users according to the design of the webpage and determine which one has a higher impact on the clinical settings, and consequently on prevention of STDs.
For the A/B test we will test the interactivity of two versions of a web page www.sjekkdeg.no: the A version (control), consisting en the educative web app; and the B version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment System.
The Game-Based Appointment System will offer the users the option of booking appointments at the venereology department at the University Hospital of North Norway. The system will include an automatic priority appointments function, with three levels of prioritization (triage): 1) Emergency-appointment: The user should go to the doctor on the same day or the following day. 2) Haste-appointment: Within 3-4 days; or 3) Routine-appointment: within 2-3 weeks.
The hypotheses of this research project are:
- The number of visits with the health professionals will be larger in the game-based appointment group than in the control group.
- The number of visits to the educative components of www.sjekkdeg.no will increase after the launch of the Game-Based Appointment System functionality.
- The number of visits to the educative components of www.sjekkdeg.no will be larger in the appointment group than in the control group.
- The time spent per visit to the website will be larger in the appointment group than in the control group, meaning a higher exposure to health information.
- The visitors returning rate is larger in the appointment group than in the control group.
Detailed description
- Compliance with strategic documents: This project is in line with recommendations made by the Norwegian Public Health Authorities, that state that ìchange of sexual practice, i.e., increased used of condoms and fewer partners, will be the main focus of containment (of sexually transmitted diseases).
- Relevance to society: The premise guiding the development of the Game-Based Appointment System is that Information and Communication Technology may facilitate the access to health services to youth regarding sexual health and prevention of sexually transmitted diseases, as well as increase their exposure in an educative environment. Early triage of health service consumers is now more and more used as an effective way to reduce expenses and the use of healthcare staff resources.
- Environmental perspectives: The project will provide a health related social network aimed at empowering the citizens to better understand and prevent sexually transmitted diseases, therefore minimizing the number of travels to visit the doctor at the healthcare service.
- Ethical aspects: The research activities will strictly follow the regulations provided by the Health Register Act (Helseregisterloven) and the Health Personnel Act (Helsepersonelloven). Both acts (with accompanying regulations) being supervised by the Ministry of Health and the Norwegian Board of Health. To guarantee approval regarding any possible use of data in a personal way, this project will pursue conformance to the regulations of the Personal Data Act (based on the European Data Protection Directive). The Personal Data act and other relevant acts and regulations are enforced and supervised by the Norwegian Data Inspectorate (Datatilsynet).
- Gender equality and gender perspectives: The planning of the this research project has stressed that the selection of participants and the conduct of the trial will all be gender-neutral.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Users randomized to the www.sjekkdeg.no A version, consisting en the educative web app, not including the Game-Based Appointment System |
| Intervention Group | Experimental | Behavioral: Game-Based Appointment SystemUsers randomized to the www.sjekkdeg.no B version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All the users reaching voluntarily the web app www.sjekkdeg.no and answering "Yes" to the question "Are you from Tromsø?" will be included in the study.
Key exclusion criteria (1 listed)
- All the users reaching voluntarily the web app www.sjekkdeg.no and answering "No" to the question "Are you from Tromsø?" will not be included in the study; however, they will be allowed to surf the website.
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 |
|---|---|---|
| Game-Based Appointment SystemUsers randomized to the www.sjekkdeg.no B version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment System | Behavioural | Intervention Group |
Primary outcome
Impact of the Game-Appointment System on the number of consultancies of sexually transmitted diseases with the health professionals in Tromso.
Time frame: After one year of the launch of the Game-Based Appointment System.
To assess if the Game-Based Appointment System increase the number of consultancies on sexually transmitted diseases with the health professionals in Tromsø, we will analyse the total number of appointments booked through the Game-Based Appointment System after 1 year of the start of the project. And we will compare the total number of sexually transmitted diseases consultancies in all health professionals Tromsø with a reference number ranging from 1000 to 1999 (Group A) versus total number of consultancies with codes ranging between 2000 and 2999 (Group B).
1 secondary outcome
Impact of the Game-Based Appointment System on the number of visits to the educative components of the web app www.sjekkdeg.no, and its utilisation.
Time frame: After one year of the launch of the Game-Based Appointment System.
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 5 Jan 2016.
- Background: PubMed 23110684Gabarron E, Serrano JA, Wynn R, Armayones M. Avatars using computer/smartphone mediated communication and social networking in prevention of sexually transmitted diseases among North-Norwegian youngsters. BMC Med Inform Decis Mak. 2012 Oct 30;12:120. doi: 10.1186/1472-6947-12-120.
- Results publication: PubMed 23920840Gabarron E, Schopf T, Serrano JA, Fernandez-Luque L, Dorronzoro E. Gamification strategy on prevention of STDs for youth. Stud Health Technol Inform. 2013;192:1066.
- Derived from this study: PubMed 25890283Gabarron E, Serrano JA, Fernandez-Luque L, Wynn R, Schopf T. Randomized trial of a novel game-based appointment system for a university hospital venereology unit: study protocol. BMC Med Inform Decis Mak. 2015 Apr 8;15:23. doi: 10.1186/s12911-015-0143-9.
- Educative web app on sexually transmitted diseases. In Norwegian.Link provided by the sponsor.
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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.
Elia Gabarron, MsC, Psych principal investigator
NST-Norwegian Center for Integrated Care and Telemedicine; University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-Based Appointment System in people with Sexually Transmitted Diseases and Chlamydia Trachomatis, run by University Hospital of North Norway at 1 site in Norway.
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 5 Jan 2016. 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 Norway. 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?
Impact of the Game-Appointment System on the number of consultancies of sexually transmitted diseases with the health professionals in Tromso. (time frame: After one year of the launch of the Game-Based Appointment System.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128620, which also lists 3 linked publications.
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 5 Jan 2016.