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

Thromboembolism Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03424330
• Other study ID #: RXC-154-2017-CLE
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2019
• Est. completion date: December 25, 2023

Study information

• Verified date: December 2023
• Source: Dosentrx Ltd.
• Contact: Ronit Shtrichman, Ph.D
• Phone: 972526500938
• Email: ronit.s[@]dosentrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 25, 2023
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

-

Related Conditions & MeSH terms

• Thromboembolism

Intervention

Device:
• ReX-C intervention
Patients receive medication by the ReX-C device

Other:
• Standard of Care
Patients receive medication as usual

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Dosentrx Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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