At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Value Analysis in Patients Undergoing Anticoagulant Therapy: Impact of Self-management Training Using a Coagulometer
In Brief
A clinical study evaluating Standard of Care (SOC) and Remote Patient Monitoring (RPM) for Post-Cardiac Surgery Patients. Completed, enrolled 28 participants across 1 site.
Detailed Summary
Prior research has not assessed the value of remote patient monitoring (RPM) systems for patients undergoing anticoagulation therapy after cardiac surgery. This study aims to assess whether the clinical follow-up through RPM yields comparable outcomes with the standard protocol. A crossover trial assigned participants to SOC-RPM or RPM-SOC, starting with the standard of care (SOC) for the first 6 months after surgery and using RPM for the following 6 months, or vice-versa, respectively. During RPM, patients used the Coaguchek© to accurately measure International Normalized Ratio values and a mobile text-based chatbot to report PROs and adjust the therapeutic dosage. The study assessed patients' and clinicians' experience with RPM and compared direct costs.
Study Details
Timeline
Interventions
The SOC intervention constitutes the common clinical practice of care that is habitually performed after cardiac surgery to manage anticoagulation therapies.
The RPM intervention involves the use of a remote patient monitoring (RPM) system with a portable coagulometer for the clinical follow-up and self-management of International Normalized Ratio (INR) control in patients undergoing anticoagulant therapy post-cardiac surgery. Patients were provided with a Coagulometer-CoaguChek® (Roche Diagnostics, Switzerland) kit and test strips, along with written instructions for conducting measurements. They were also enrolled in a monitoring platform. Patients received regular text messages on their smartphones to report their INR values and symptoms related to anticoagulant therapy. The clinical team received notifications if patients\' reports fell outside therapeutic standards and then responded with medication adjustments via text message.