Questionnaires for a randomized controlled trial methodology to evaluate the teaching utility of diabetes simulation...

Area of Science:

• Medical Education
• Health Informatics
• Diabetes Management

Background:

• The AIDA interactive diabetes simulator has been freely available online since 1996, with significant user engagement.
• Despite widespread use, the educational utility of AIDA for patients with type 1 diabetes mellitus has not been rigorously evaluated in a clinical setting.

Purpose of the Study:

• To propose and detail a prospective randomized controlled trial (RCT) methodology for formally assessing the educational impact of the AIDA simulator.
• To establish an objective evaluation framework for interactive diabetes educational tools.

Main Methods:

• A two-arm prospective RCT comparing the AIDA simulator (active intervention) against conventional educational methods (control).
• Six weekly lessons for each arm, with data collection on self-monitoring of blood glucose (SMBG), hypoglycemia, HbA1c, and patient-reported outcomes (self-confidence, quality of life, metabolic control, attitudes, knowledge).
• A partial cross-over design is included to allow all participants eventual access to the AIDA simulator and enhance statistical power.

Main Results:

• The study protocol is designed to compare outcomes between the AIDA intervention group and the control group using statistical analyses.
• The cross-over design will enable within-group paired analyses, increasing statistical power.

Conclusions:

• The proposed RCT methodology provides a robust framework for evaluating the educational utility of interactive diabetes simulators like AIDA.
• Objective demonstration of AIDA's effectiveness is crucial for its validated application in type 1 diabetes education.