Clinical trial NCT06335758: Non-randomized Observational Study to Evaluate ReX® in the Management of Solid Oral Medication.
Official title: Non-randomized Observational Study to Collate Data Regarding the Safety, Efficacy and Satisfaction of ReX® in the Management of Solid Oral Medications.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Any Solid Oral Medication
Keywords: Solid oral medication
Lead sponsor: Dosentrx Ltd.
Sponsor class: INDUSTRY
Collaborators: name: US Oncology Research
First posted: 2024-03-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive treatment with solid oral medication as a standard of care within ReX.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment duration
timeFrame: 24 weeks
measure: Patient satisfaction
timeFrame: 24 weeks
measure: Adverse events
timeFrame: 24 weeks
measure: Patient adherence
timeFrame: 24 weeks
measure: Patient compliance
timeFrame: 24 weeks
measure: Patient engagement
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: OHC
state: Ohio
Study officials:
affiliation: US Oncology
name: David Waterhouse, MD
role: PRINCIPAL_INVESTIGATOR
References: