Evaluation of ReX-C System in Measurement and Improvement of Patients' Adherence.
NCT ID: NCT03424330
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2019-01-09
2023-12-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
OTHER
NONE
Study Groups
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Arm1 - ReX first
Subjects begin with the ReX-C Intervention stage followed by Standard of Care stage.
ReX-C intervention
Patients receive medication by the ReX-C device
Standard of Care
Patients receive medication as usual
Arm 2- Standard of Care first
Subjects start with Standard of Care stage followed by ReX-C Intervention.
ReX-C intervention
Patients receive medication by the ReX-C device
Standard of Care
Patients receive medication as usual
Interventions
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ReX-C intervention
Patients receive medication by the ReX-C device
Standard of Care
Patients receive medication as usual
Eligibility Criteria
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Inclusion Criteria
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
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.
\-
18 Years
ALL
No
Sponsors
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Dosentrx Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Meir Preis, MD
Role: PRINCIPAL_INVESTIGATOR
Carmel Medical Center, Haifa, Israel
Locations
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Carmel Medical Center
Haifa, , Israel
Countries
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Central Contacts
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Facility Contacts
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Meir Preis, MD
Role: primary
Other Identifiers
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RXC-154-2017-CLE
Identifier Type: -
Identifier Source: org_study_id