CARNA – Evaluation study on the positive care effect of a mobile app

Improving care for heart failure patients with the help of a digital health app

Using the »DPM.research« eCRF.system with heart failure patients


The objective of the CARNA clinical study is to investigate whether the use of a mobile patient app in the home environment leads to a positive care effect (according to Germany’s Digital Care Act [DVG]) in patients with heart failure. It is also intended to serve as evidence in the context of a “fast-track procedure.” This is a prerequisite for registering the mobile patient app as a digital health application (DiGA) for standard care with the German Federal Institute for Drugs and Medical Devices (BfArM).



For patients with heart failure, regular monitoring of their health status to adjust treatment and prevent complications is a critical component of care. Telemedicine interventions that facilitate such regular monitoring have thus resulted in positive care effects in previous studies.

In this study, this aspect will be investigated using a mobile app that allows patients to independently monitor their health status with the help of measuring devices or wearables (blood pressure device, pulse oximeter, scale, thermometer). Patients are informed early on if their measurements deviate from the norm, so that – accompanied by the app and together with the attending physician – they can take the necessary steps for optimal treatment. In addition, the app includes functions for targeted knowledge transfer about the disease and condition-specific instructions for action, thus ensuring personalized care.

Digital tools for conducting and evaluating clinical studies

App for data collection directly from the patient
© Fraunhofer IIS
  • Digital data collection and evaluation of questionnaires based on the DPM.research study management system
  • Algorithm for study-specific randomization of subjects
  • Patient-specific user interface for answering questionnaires via QR code


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