Non-randomized Observational Study to Evaluate ReX® in the Management of Solid Oral Medication. (RegStud)

Non-randomized Observational Study to Collate Data Regarding the Safety, Efficacy and Satisfaction of ReX® in the Management of Solid Oral Medications.

The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.

The study will evaluate and monitor use of ReX in respect of:

• treatment duration
• adverse events
• patient adherence and compliance
• engagement with ReX via patient-reported outcomes

Patients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen.

Study Overview

• Status: Recruiting
• Conditions: Any Solid Oral Medication
• Intervention / Treatment: Device: Use of ReX to dispense and monitor solid oral medication therapy.

Detailed Description

The ReX platform is a class 1 FDA device listed under product code NXB Dispenser Solid Medication. It comprises:

• Hand-held medication dispenser with touch screen (ReX Remote Digital Nurse).
• Disposable cartridge pre-loaded with pills or capsules. The cartridge includes an integral mouthpiece. Patients inhale at the mouthpiece causing pills to be dispensed into the mouth.
• Web application (ReX Treatment Manager) which collects data generated by the ReX hand-held dispenser.

ReX manages and monitors medication-based therapy by means of:

• Reminders to take pills. Reminders are sent to patients and caregivers by email, SMS or via the telephone support team.
• Electronic patient recorded outcomes (ePROs) presented to patients via the dispenser touch screen. ePROs include questions, tips and reminders.
• Notifications sent by email or SMS in the event of the patient exceeding a pre-defined threshold.

In this study, following training, patients will be offered their standard oral medication via the ReX Remote Digital Nurse. They will receive cartridges pre-loaded with medication by the pharmacy. Safety, efficacy and patient satisfaction with the device are monitored over a 24-week period by phone calls and periodic questionnaires.

Data collected by the ReX Remote Digital Nurse include:

• medication name
• prescribed dosage
• doses taken per day
• pills taken per dose
• ePRO responses
• missed pill intakes

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Natan Paz; Phone Number: +972 52 6577126; Email: natan.p@dosentrx.com

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • OHC
      • Contact: Zachary Beck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who receive treatment with solid oral medication as a standard of care within ReX.

Description

Inclusion Criteria:

1. 18 years of age or older.
2. Care team recommends the use of ReX as a standard of care.
3. Patients have 5th grade reading level.
4. Patient was prescribed oral medication.
5. Patient takes medication at home.

Exclusion Criteria:

1. Patient 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 or use the ReX dispensing unit effectively.
2. Patient failed to pass the learning module during ReX onboarding flow.
3. Patient is at end stage or terminal illness with anticipated life expectancy of 6 months or less.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving solid oral medication as a standard of care.; Solid oral medication administered via the ReX Remote Digital Nurse.	Device: Use of ReX to dispense and monitor solid oral medication therapy.; ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment duration	At least 3 months while using ReX	24 weeks
Patient satisfaction	At least 3.5 on a scale up to 5	24 weeks
Adverse events	None related to use of ReX	24 weeks
Patient adherence	No. of pills taken by patient as a percentage of pills prescribed >80%	24 weeks
Patient compliance	No. of pills taken as percentage of pills to be taken in alloted time frame >70%	24 weeks
Patient engagement	No. of questions answered as a percentage of questions asked >70% of ePROs	24 weeks

Collaborators and Investigators

• Sponsor: Dosentrx Ltd.
• Collaborators: US Oncology Research
• Investigators: Principal Investigator: David Waterhouse, MD, US Oncology

Publications and helpful links

Helpful Links

• Website of ReX Remote Digital Nurse

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Solid oral medication
• Other Study ID Numbers: EXC-039-2023-CLR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No