Overview
The study aims to evaluate the safety, usability and efficacy of the ReX-C - a novel medication management system - in measurement and improvement of adherence, in patients receiving oral anti-coagulation therapy for the treatment and prevention of thromboembolism.
Description
ReX-C is a mobile system intended to provide solid, oral medication on patient demand, according to a pre-programmed treatment protocol. ReX-C addresses poor adherence to medication therapy by providing real-time, reliable adherence data to caregivers and timely, personalized reminders to patients.
During the study, the use of ReX-C system to receive medications will be compared to Standard of Care. Patients' adherence will be evaluated for both methods.
Eligibility
Inclusion Criteria:
- Male or Female, at least 18 years of age
- Subject is able to swallow pills and use ReX-C device to receive medication.
- Subject is able to read and understand the Informed Consent Form.
- Subject receives anti-coagulants for the treatment and prevention of thromboembolism events, (e.g: Arterial Fibrillation (AF), Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)).
- Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran),
Xarelto® (rivaroxaban) and Eliquis® (apixaban).
- Subject is recruited at least 1 month after treatment initiation and has stable dose regime.
- Subject receives stable dose of medication for at least a month.
- Subject takes medication therapy at home.
Exclusion Criteria:
- Subject has significant physical disability including; poor fine motor skills, impaired visual or auditory faculties, mental disorders or other impairment affecting ability to provide Informed Consent Form or use the ReX-C dispensing unit effectively.
- Subject cen not use ReX-C to receive medications.
- Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
- Subject is at end stage or terminal illness with anticipated life expectancy of 6
months or less.
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