Recruiting

ReX®

Sponsor:

Dosentrx Ltd.

Code:

NCT06335758

Conditions

Any Solid Oral Medication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06335758

Start date

Jan 15, 2024

Status verified date

Dec, 2023

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients receiving solid oral medication as a standard of care.

Solid oral medication administered via the ReX Remote Digital Nurse.

Interventions

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).

Primary outcome measure

  • Treatment duration [ Time Frame: 24 weeks ]
  • Patient satisfaction [ Time Frame: 24 weeks ]
  • Adverse events [ Time Frame: 24 weeks ]
  • Patient adherence [ Time Frame: 24 weeks ]
  • Patient compliance [ Time Frame: 24 weeks ]
  • Patient engagement [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Natan Paz

+972 52 6577126natan.p@dosentrx.com

Locations

OHC

Recruiting

Cincinnati, Ohio, United States, 45242

More Information

Sponsor

Dosentrx Ltd.

Last update posted

Mar 28, 2024

Last verified

Dec, 2023

Keywords

  • Solid oral medication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dosentrx Ltd. on 2024-03-28.