A randomised-controlled clinical trial methodology for evaluating the teaching utility of interactive educational diabetes simulators.

AIDA is an interactive educational diabetes simulator which has been made available without charge on the Internet. Since its launch on the World Wide Web in 1996 over 58,000 people have visited the AIDA Web site (http://www.2aida.org) and over 17,500 copies of the program have been downloaded from there free-of-charge. The AIDA software is believed to be of use in recreating clinical (diabetes) situations for interactive simulation. However, despite its widespread usage, its actual utility for supporting the education of patients with Type 1 diabetes mellitus remains to be objectively demonstrated in a randomised-controlled clinical trial setting. This paper describes a prospective, randomised-controlled trial (RCT) methodology for formally evaluating the educational utility of an interactive diabetes simulator, like AIDA. The protocol makes use of two study arms, each receiving different educational interventions. During lessons, Arm A of the study will be exposed to the AIDA simulator (the active intervention), while Arm B (the control group) will benefit from conventional educational methods using standard presentations with slides and transparencies. Six lessons will be held for each study arm (one per week). At the beginning and end of the study self-monitoring blood glucose (SMBG) data will be collected, details of any hypoglycaemic episodes recorded, and assessments made of HbA1c. Participants will also be required to complete a detailed questionnaire to assess their self-confidence, quality of life and metabolic control, attitudes towards SMBG, and knowledge about insulin dosage calculation. Comparisons will be made between Arm A and Arm B using unpaired statistical analyses. A partial cross-over study design is also proposed whereby subsequently the control group will be exposed to the AIDA simulator during a further 6-week course of lessons. This will ensure that the maximum number of subjects will eventually receive the active intervention, and will also allow further within group paired analyses to be applied (with greater statistical power). An initial evaluation study using this RCT approach has just recently commenced in the Ospedale di Marino in Marino (Rome), Italy.