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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Thromboembolism
• Intervention / Treatment: Device: ReX-C intervention; Other: Standard of Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronit Shtrichman, Ph.D; Phone Number: 972526500938; Email: ronit.s@dosentrx.com
• Study Contact Backup: Name: Hadas ONeill, BA; Phone Number: +972503221947; Email: hadas@post.com

Study Locations

• Israel
  • Haifa, Israel, 3436212
    • Recruiting
    • Carmel Medical Center
    • Contact: Meir Preis, MD; Email: MeirPr@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dosentrx Ltd.
• Investigators: Principal Investigator: Meir Preis, MD, Carmel Medical Center, Haifa, Israel

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Estimated): December 25, 2023
• Study Completion (Estimated): December 25, 2023

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: RXC-154-2017-CLE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No