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

Last updated: December 11, 2023
Sponsor: Dosentrx Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thromboembolism

Treatment

Standard of Care

ReX-C intervention

Clinical Study ID

NCT03424330
RXC-154-2017-CLE
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 thromboembolismevents, (e.g: Arterial Fibrillation (AF), Deep Vein Thrombosis (DVT) or PulmonaryEmbolism (PE)).
  5. Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran),Xarelto® (rivaroxaban) and Eliquis® (apixaban).
  6. Subject is recruited at least 1 month after treatment initiation and has stabledose regime.
  7. Subject receives stable dose of medication for at least a month.
  8. Subject takes medication therapy at home.

Exclusion

Exclusion Criteria: 1. Subject has significant physical disability including; poor fine motor skills,impaired visual or auditory faculties, mental disorders or other impairment affectingability 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 participationin two studies simultaneously. 4. Subject is at end stage or terminal illness with anticipated life expectancy of 6months or less.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Standard of Care
Phase:
Study Start date:
January 09, 2019
Estimated Completion Date:
December 25, 2023

Study 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.

Connect with a study center

  • Carmel Medical Center

    Haifa, 3436212
    Israel

    Active - Recruiting

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