Enhancing Trial Data and Patient Reported Outcomes ‘PRO’, Leveraging mHealth Technology for an mPowered Patient

An important part of clinical research is which data to capture and the media used for capturing this.
In the new era of clinical research, patient reported outcomes are much emphasised upon and more frequently becoming the center of data collection in clinical trials (1). The class I CE-marked Monsenso solution is a data collection and assessment tool, which is the product of a EU-funded STREP project, called MONARCA, in which it was developed and clinically validated through a range of clinical pilot studies and randomised controlled trials. The MONARCA project aimed to develop and clinically validate a user-centred system for treatment and self-management of bipolar disorder. The clinical trials showed that the platform had a high user satisfaction and engagement, alongside high compliance rates to self-assessment between 87-93%. The Monsenso solution delivers flexible and complex data collection possibilities, by combining subjective data (PRO’s’), captured through configurable self-assessments, with objective data captured through sensors of a smartphone, and presenting them to a clinical web portal in real-time. With a simple and discrete mobile self-assessment, the patients will have a much easier way of completing and sharing their questionnaires with clinicians, as opposed to paper based assessments. The convenient way of completing assessments, alongside presentation of results historically, will engage patients to comply and clinicians to receive high quality data sets.

(1) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3227331/