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

Dosentrx

Status: Enrolling

Conditions: Thromboembolism

Treatments: Other: Standard of Care; Device: ReX-C intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT03424330

RXC-154-2017-CLE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female, at least 18 years of age

2. Subject is able to swallow pills and use ReX-C device to receive medication.

3. Subject is able to read and understand the Informed Consent Form.

4. 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)).

5. Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban).

   1. Subject is recruited at least 1 month after treatment initiation and has stable dose regime.
   2. Subject receives stable dose of medication for at least a month.

6. Subject takes medication therapy at home.

Exclusion criteria

1. 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.

2. Subject cen not use ReX-C to receive medications.

3. Subject is participating in another clinical study that does not permit participation in two studies simultaneously.

4. Subject is at end stage or terminal illness with anticipated life expectancy of 6 months or less.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm1 - ReX first

Experimental group

Description:

Subjects begin with the ReX-C Intervention stage followed by Standard of Care stage.

Treatment:

Other: Standard of Care

Device: ReX-C intervention

Arm 2- Standard of Care first

Experimental group

Description:

Subjects start with Standard of Care stage followed by ReX-C Intervention.

Treatment:

Other: Standard of Care

Device: ReX-C intervention