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A Randomized Online Health Experiment for a Safer Youth Sexual Behaviour

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University Hospital of North Norway
Sponsor:
Collaborator:
Helse Nord
Information provided by (Responsible Party):
Elia Gabarron, University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT02128620
First received: April 29, 2014
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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:

  1. The number of visits with the health professionals will be larger in the game-based appointment group than in the control group.
  2. The number of visits to the educative components of www.sjekkdeg.no will increase after the launch of the Game-Based Appointment System functionality.
  3. The number of visits to the educative components of www.sjekkdeg.no will be larger in the appointment group than in the control group.
  4. 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.
  5. The visitors returning rate is larger in the appointment group than in the control group.

Condition Intervention
Sexually Transmitted Diseases
Chlamydia Trachomatis
Behavioral: Game-Based Appointment System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Study on Sexually Transmitted Diseases Prevention - Introduction of a Novel Game-based Appointment System for Youth

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Opinion of health professionals on the benefit from the Game-Based Appointment System. [ Time Frame: After one year of the launch of the Game-Based Appointment System. ] [ Designated as safety issue: No ]
    To assess if health professionals (doctors and nurses) can have a benefit from such a system through reduced consultation times due to previous acquired information by the symptom checker, a qualitative approach consisting on an adhoc questionnaire based on the Technology Acceptance Model.

  • Opinion of users on the benefit from the Game-Based Appointment System. [ Time Frame: After one year of the launch of the Game-Based Appointment System. ] [ Designated as safety issue: No ]
    To assess if the users can have a benefit from this Game-Based Appointment System and how this functionality helped them in the decision to book an appointment at the doctor, a qualitative approach, consisting on an adhoc questionnaire based on the Technology Acceptance Model.


Estimated Enrollment: 1000
Study Start Date: July 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Users randomized to the www.sjekkdeg.no A version, consisting en the educative web app, not including the Game-Based Appointment System
Experimental: Intervention Group
Users randomized to the www.sjekkdeg.no B version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment System
Behavioral: Game-Based Appointment System
Users randomized to the www.sjekkdeg.no B version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment System

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128620

Contacts
Contact: Elia Gabarron, MsC, Psych 004794863460 elia.gabarron@telemed.no

Locations
Norway
NST-Norwegian Center for Integrated Care and Telemedicine; University Hospital of North Norway Not yet recruiting
Tromso, Norway, 9019
Sub-Investigator: Thomas R Schopf, MD, Dermat         
Sub-Investigator: Artur Serrano, PhD, Comp Sc         
Sub-Investigator: Luis Fernández-Luque, MsC, Comp Sc         
Sub-Investigator: Rolf Wynn, Prof, Cl Med         
Principal Investigator: Elia Gabarron, MsC, Pysch         
Sponsors and Collaborators
University Hospital of North Norway
Helse Nord
Investigators
Principal Investigator: Elia Gabarron, MsC, Psych NST-Norwegian Center for Integrated Care and Telemedicine; University Hospital of North Norway
  More Information

Additional Information:
Publications:
Responsible Party: Elia Gabarron, MsC, Psych, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02128620     History of Changes
Other Study ID Numbers: NST-40656
Study First Received: April 29, 2014
Last Updated: April 30, 2014
Health Authority: Norway: Data Protection Authority

Keywords provided by University Hospital of North Norway:
Sexually transmitted diseases
Internet
Education
Appointments and Schedules

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Infection
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014