NCT03424330

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 9, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

5 years

First QC Date

January 15, 2018

Last Update Submit

December 11, 2023

Conditions

Thromboembolism

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Adherence rate measured by patient's plasma drug level

    18 weeks

Study Arms (2)

Arm1 - ReX first

EXPERIMENTAL

Subjects begin with the ReX-C Intervention stage followed by Standard of Care stage.

Device: ReX-C interventionOther: Standard of Care

Arm 2- Standard of Care first

EXPERIMENTAL

Subjects start with Standard of Care stage followed by ReX-C Intervention.

Device: ReX-C interventionOther: Standard of Care

Interventions

ReX-C interventionDEVICE

Patients receive medication by the ReX-C device

Arm 2- Standard of Care firstArm1 - ReX first
Standard of CareOTHER

Patients receive medication as usual

Arm 2- Standard of Care firstArm1 - ReX first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, 3436212, Israel

RECRUITING

MeSH Terms

Conditions

Thromboembolism

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Meir Preis, MD

    Carmel Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronit Shtrichman, Ph.D

CONTACT

972526500938ronit.s@dosentrx.com

Hadas ONeill, BA

CONTACT

+972503221947hadas@post.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2018

First Posted

February 7, 2018

Study Start

January 9, 2019

Primary Completion

December 25, 2023

Study Completion

December 25, 2023

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

IL(1)