Evaluation of a medication management system for improving adherence in patients on anticoagulants

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.

This study tests a new mobile app that helps people on blood thinners remember to take their medications and see if it works better than regular care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dosentrx Ltd. (Industry-sponsored)
• Locations: 1 site (Haifa)
• Trial ID: NCT03424330 on ClinicalTrials.gov

What this trial studies

This study evaluates the ReX-C system, a novel mobile medication management tool designed to enhance adherence among patients receiving oral anticoagulation therapy for thromboembolism. The ReX-C system provides medications on demand and offers real-time adherence data to caregivers, along with personalized reminders for patients. The effectiveness of the ReX-C system will be compared to standard care in terms of medication adherence. Participants will be monitored for their ability to use the device and their adherence to prescribed therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are stable on a prescribed oral anticoagulant regimen for thromboembolism treatment.

Not a fit: Patients with significant physical disabilities or impairments that affect their ability to use the ReX-C device or provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve medication adherence in patients on anticoagulants, potentially reducing thromboembolism events.

How similar studies have performed: Other studies have shown promise in using technology to improve medication adherence, suggesting that this approach may be effective.

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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Where this trial is running

Haifa

• Carmel Medical Center — Haifa, Israel (Recruiting)

Study contacts

• Principal investigator: Meir Preis, MD — Carmel Medical Center, Haifa, Israel
• Study coordinator: Ronit Shtrichman, Ph.D

Conditions Thromboembolism