Patient safety and quality of care are at risk if the informed consent process does not emphasize patient comprehension. In this paper, we describe how we designed, developed, and evaluated an mHealth tool for advancing the informed consent process. Our tool enables the informed consent process to be performed on tablets (e.g., iPads) utilizing virtual coaching with text-to-speech automated translation as well as an interactive multimedia elements (e.g., graphics, video clips, animations, presentations, etc.). We designed our tool to enhance patient comprehension and quality of care, while improving the efficiency of obtaining patient consent. We present the Used-Centered Design approach we adopted to develop the tool and the results of the different methods we used during the development of the tool. Also, we describe the results of the usability study which we conducted to evaluate the effectiveness, efficiency, and user satisfaction with our mHealth App to enhance the informed consent process. Using the UCD approach we were able to design, develop, and evaluate a highly interactive mHealth App to deliver the informed consent process.
Keywords: informed consent; mHealth; user-centered design.