Evaluation of ReX-C System in Measurement and Improvement of Patients' Adherence.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of ReX-C System in Measurement and Improvement of Adherence, in Patients Receiving Oral Anti-coagulation Therapy for the Treatment and Prevention of Thromboembolism.

Conditions
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Thromboembolism

Intervention / Treatment
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* Device: ReX-C intervention
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study will employ a randomized, controlled crossover study design. The study comprises two stages: Stage 1: ReX-C Intervention in which subjects will use ReX-C to receive medication. Stage 2: Control, in which Treatment as Usual (TAU). All subjects enrolled for the study will participate in both stages in a randomized crossover mode.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1 - ReX first<br>Subjects begin with the ReX-C Intervention stage followed by Standard of Care stage. | Device: ReX-C intervention<br>* Patients receive medication by the ReX-C device<br>Other: Standard of Care<br>* Patients receive medication as usual<br>|
| Experimental: Arm 2- Standard of Care first<br>Subjects start with Standard of Care stage followed by ReX-C Intervention. | Device: ReX-C intervention<br>* Patients receive medication by the ReX-C device<br>Other: Standard of Care<br>* Patients receive medication as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of ReX- C system, measured by incidences of pill overdose, pills malformation and adverse events related to the device use. | incidences of pill overdose, pills malformation and adverse events related to the device use will be measured by a questionnaire. | 18 weeks | 
| Ease of use and acceptance of ReX-C system measured by a questionnaire | Patients will be asked about their experience with ReX-C. | 18 weeks | 
| ReX-C capability to assess patient's adherence, measured by ReX-C record of missed/ delayed dose. | Any event of delayed pill intake recorded by ReX-C should lead to a personal reminder to patient, who has to confirm the delay and act to take the missing dose. | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate measured by patient's plasma drug level | A comparison of adherence rate, measured by patient's plasma drug level, between ReX intervention stage and Standard of Care stage | 18 weeks |