The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare has selected digital trials platform provider Medable’s Cloud-based platform to study statin-related adverse events.
Medable’s platform will evaluate the events using electronic patient-reported outcomes in a digital trial.
The digital study helps monitor participant response to statin medications through an application.
It notifies clinicians and patients when the patient should stop or start their medication based on presenting symptoms gathered through electronic patient-reported outcomes.
The app identifies statin-intolerant individuals in the study by assessing the pattern, location and timing of the patients’ muscle symptoms.
Statins, a set of cholesterol-lowering medications that inhibit 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase, are administered to treat atherosclerotic cardiovascular disease (CVD).
The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) method is used to assess the likelihood that a patient’s muscle symptoms are either caused or worsened by statin use.
UConn Kinesiology associate professor and lead study investigator Dr Beth Taylor said: “The problem with SAMS is that there are no diagnostic tests for this condition and clinicians have to rely on patient-reported perceptions of pain that may have occurred months or even years ago.
“We wanted to digitise the paper questionnaire into a clinical index onto an app, where patients could take their statin medication at home, and rank their pain levels in real-time.
“Medable was able to help us conceptualise the initial research idea into a patient-friendly app, and we wouldn’t have been able to do this without their guidance.”
Lipitor and Crestor statins are widely used drugs for treating a series of cholesterol-independent diseases.
Medable co-founder and CEO Dr Michelle Longmire said: “Dr Taylor’s research is critical to understanding the real-world effects of widely prescribed medications.”