The BD4QoL mobile app has been used for more than three months from patients that have survived from Head and Neck Cancer, in the scope of a clinical trial. The purpose of the study is to demonstrate whether the mobile app can help patients improve their way of living. The app itself has been improved to generate summative evidence on the criteria that are commonly set for user assessment of mHealth apps. A set of rigorous and appropriate criteria have been chosen and quality rules automatically generate related clinical trial evaluation results. The process of evaluating the health app is ongoing and we expect a full set of results in the next 24 months.

Specifically, a set of about one hundred quality rules have been identified to check the quality of the clinical trial operation. These rules refer to both the control and the intervention arm of the trial. They refer to issues that cover matters of a) coherence, b) compliance and c) sustainability. The coherence dimension investigates whether the minimum requirements of consistency are covered, and that is assessing mainly whether the coupled 6monthly questionnaires are appropriately filled in by patients. Compliance refers to assessing whether the minimum requirements for entering the clinical trial are met throughout the trial duration. Finally, Sustainability refers to assessing the time within which compliance criteria remain valid.

To investigate these trial dimensions a set of quality rules have been identified and grouped in these categories: a) patient bahavior while “using” the BD4QoL platform, b) patient engagement with the “Bidi” chatbot, c) completion of 6monthly questionnaires and d) other general issues.

The findings are expected to provide fruitful knowledge for lessons learned for operating successful clinical trials.