4.2.3. Procedure

Adolescents and their parents were contacted and informed about the study by their pediatrician or specialized diabetes nurses working at the pediatric diabetes department of Gelderse Vallei Hospital in Ede (the Netherlands) where both studies were performed. Adolescents who expressed their interest in participating in the study and fulfilled the inclusion criteria were sent an information letter including an informed consent form. After two weeks, participants were contacted to see if they had any further questions and to plan the first hospital visit. During the first hospital visit, participants were informed about the specific components of the PERGAMON platform (i.e., sensor network, virtual coach and serious game) in more detail and were offered support with downloading and installation of the applications on their Android device. The pre-pilot group participants evaluated the platform for two weeks at home and the subsequent pilot group participants were allowed to use the PERGAMON platform for six to eight weeks at home. No instructions were given for doing specific tasks. This was done to stimulate the report of technical or other issues naturally encountered during use in real life. A technical help desk, covered by the nurses and researchers involved, was available during the study period through contact by email or phone during office hours. Apart from the online questionnaires filled in during the pre- and post-test hospital visits, participants had the opportunity to share their experiences concerning usability and acceptability in a focus group during the second hospital visit.

The focus group was guided by a short outline presented through PowerPoint and ended with an open discussion about suggestions on how to improve the performance and adequacy of the platform. The focus group was moderated by a researcher experienced in usability research and testing. A second researcher (i.e., nurse) was present and made field notes.

All participants and one of their parents (or legal guardians) gave their informed consent for inclusion before they participated in the study. Both studies were conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of the Gelderse Vallei Hospital (BC/1606-383) on 1st of August 2016 and by Coventry University (P45142) on 29th of June 2016.
