Back to resultsEvaluation of ReX-C System in Measurement and Improvement of Patients' Adherence.
Primary Purpose
Thromboembolism
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ReX-C intervention
Standard of Care
Sponsored by
About this trial
This is an interventional other trial for Thromboembolism
Eligibility Criteria
Inclusion Criteria:
- Male or Female, at least 18 years of age
- Subject is able to swallow pills and use ReX-C device to receive medication.
- Subject is able to read and understand the Informed Consent Form.
- 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)).
Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban).
- Subject is recruited at least 1 month after treatment initiation and has stable dose regime.
- Subject receives stable dose of medication for at least a month.
- Subject takes medication therapy at home.
Exclusion Criteria:
- 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.
- Subject cen not use ReX-C to receive medications.
- Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
Subject is at end stage or terminal illness with anticipated life expectancy of 6 months or less.
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Sites / Locations
- Carmel Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm1 - ReX first
Arm 2- Standard of Care first
Arm Description
Subjects begin with the ReX-C Intervention stage followed by Standard of Care stage.
Subjects start with Standard of Care stage followed by ReX-C Intervention.
Outcomes
Primary Outcome Measures
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.
Ease of use and acceptance of ReX-C system measured by a questionnaire
Patients will be asked about their experience with ReX-C.
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03424330
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dosentrx Ltd.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm1 - ReX first
Arm Type
Experimental
Arm Description
Subjects begin with the ReX-C Intervention stage followed by Standard of Care stage.
Arm Title
Arm 2- Standard of Care first
Arm Type
Experimental
Arm Description
Subjects start with Standard of Care stage followed by ReX-C Intervention.
Intervention Type
Device
Intervention Name(s)
ReX-C intervention
Intervention Description
Patients receive medication by the ReX-C device
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Patients receive medication as usual
Primary Outcome Measure Information:
Title
Safety of ReX- C system, measured by incidences of pill overdose, pills malformation and adverse events related to the device use.
Description
incidences of pill overdose, pills malformation and adverse events related to the device use will be measured by a questionnaire.
Time Frame
18 weeks
Title
Ease of use and acceptance of ReX-C system measured by a questionnaire
Description
Patients will be asked about their experience with ReX-C.
Time Frame
18 weeks
Title
ReX-C capability to assess patient's adherence, measured by ReX-C record of missed/ delayed dose.
Description
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.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Adherence rate measured by patient's plasma drug level
Description
A comparison of adherence rate, measured by patient's plasma drug level, between ReX intervention stage and Standard of Care stage
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female, at least 18 years of age
Subject is able to swallow pills and use ReX-C device to receive medication.
Subject is able to read and understand the Informed Consent Form.
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)).
Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban).
Subject is recruited at least 1 month after treatment initiation and has stable dose regime.
Subject receives stable dose of medication for at least a month.
Subject takes medication therapy at home.
Exclusion Criteria:
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.
Subject cen not use ReX-C to receive medications.
Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
Subject is at end stage or terminal illness with anticipated life expectancy of 6 months or less.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronit Shtrichman, Ph.D
Phone
972526500938
Email
ronit.s@dosentrx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas ONeill, BA
Phone
+972503221947
Email
hadas@post.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meir Preis, MD
Organizational Affiliation
Carmel Medical Center, Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meir Preis, MD
Email
MeirPr@clalit.org.il
12. IPD Sharing Statement
Learn more about this trial
Evaluation of ReX-C System in Measurement and Improvement of Patients' Adherence.
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