Clinical trial NCT03424330: Evaluation of ReX-C System in Measurement and Improvement of Patients' Adherence.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thromboembolism
Lead sponsor: Dosentrx Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Safety of ReX- C system, measured by incidences of pill overdose, pills malformation and adverse events related to the device use.
timeFrame: 18 weeks
measure: Ease of use and acceptance of ReX-C system measured by a questionnaire
timeFrame: 18 weeks
measure: ReX-C capability to assess patient's adherence, measured by ReX-C record of missed/ delayed dose.
timeFrame: 18 weeks
Secondary outcomes:
measure: Adherence rate measured by patient's plasma drug level
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center, Haifa, Israel
name: Meir Preis, MD
role: PRINCIPAL_INVESTIGATOR
References: