Yale University and Rochester, Minn.-based Mayo Clinic are partnering with Bifourmis, a digital therapeutics company, to study the use of patient-measured data to determine effective drug development for heart failure patients.
The study will be led by the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation, a joint collaboration between Yale University, Mayo Clinic and the FDA. The study is set to launch in August and will analyze biometric data of recently discharged heart failure patients, who will be screened and then monitored at home for 60 days.
Study participants will use Biofourmis' mobile health platform to monitor their physiological biomarkers. The platform is compatible with wearable biosensors, including the Apple Watch and medical-grade wearable device Everion, which participants will wear throughout the study to track their health. The Biofourmis platform can extract raw biosensor data from the wearables and apply machine learning to detect signs of worsening heart failure weeks in advance.
Biofourmis' platform will also be used to electronically record patient-measured outcomes, including medication adherence, symptoms and a mobile-based two-minute step test. Participants will also be required to complete the Kansas City Cardiomyopathy Questionnaire, a self-administered assessment to measure the patient's perception of their heart health status. This data will help researchers determine participants' medication adherence, dose changes and target dosages for heart failure therapies.