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

NCT06335758 | Unknown

• 1 other identifier: EXC-039-2023-CLR
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Any Solid Oral Medication

Keywords

Solid oral medication

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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.

Interventions

Use of ReX to dispense and monitor solid oral medication therapy. DEVICE

ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager).

Patients receiving solid oral medication as a standard of care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.
• Patient failed to pass the learning module during ReX onboarding flow.
• Patient is at end stage or terminal illness with anticipated life expectancy of 6 months or less.

Sponsors & Collaborators

• Dosentrx Ltd.: lead
• US Oncology Research: collaborator

Study Sites (1)

OHC

Cincinnati, Ohio, 45242, United States

RECRUITING

Related Links

• Website of ReX Remote Digital Nurse

Study Officials

• David Waterhouse, MD

  US Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natan Paz

CONTACT

+972 52 6577126; natan.p@dosentrx.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: March 28, 2024
• Study Start: January 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 28, 2024

Record last verified: 2023-12

Locations

US (1)