Study of iATROS Digital Therapy for Managing Risk Factors in Adults with Coronary Heart Disease

What this Trial Is About

Researchers are studying the effectiveness of the iATROS digital therapy management system to help adjust risk factors in patients with coronary heart disease CHD. The study compares this digital approach to the standard medical care currently used. It also aims to test how well the iATROS platforms rule engine works in treating CHD and explores using smartphones for ongoing prevention and therapy management in daily life. Participants are randomly assigned to one of two groups. The intervention group uses the iATROS medical device and app, along with measuring devices to track vital signs at home. This active treatment phase lasts 9 months, followed by an additional 9 months where patients continue using the device to assess the stability of results. The control group receives standard care for 9 months without intervention, then gains access to the iATROS device and measuring tools to observe effects after their delayed use. During the study, participants will have their LDL cholesterol and blood pressure monitored, along with other measures like blood sugar levels for diabetic patients, body mass index for those with obesity, and smoking cessation status for smokers. Health literacy and patient independence are also assessed at 9 and 18 months. The study includes regular assessments of these outcomes and safety checks over a total of 18 months to evaluate the lasting impact of the digital therapy management.

Clinical Study for the Investigation and Validation of a Therapy Procedure for the Adjustment of Risk Factors in Patients With Coronary Heart Disease by Means of Digital Therapy Control