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| Name | Class |
|---|---|
| US Oncology Research | INDUSTRY |
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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:
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.
The ReX platform is a class 1 FDA device listed under product code NXB Dispenser Solid Medication. It comprises:
ReX manages and monitors medication-based therapy by means of:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving solid oral medication as a standard of care. | Solid oral medication administered via the ReX Remote Digital Nurse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who receive treatment with solid oral medication as a standard of care within ReX.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natan Paz | Contact | +972 52 6577126 | natan.p@dosentrx.com |
| Name | Affiliation | Role |
|---|---|---|
| David Waterhouse, MD | US Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHC | Recruiting | Cincinnati | Ohio | 45242 | United States |
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| Label | URL |
|---|---|
| Website of ReX Remote Digital Nurse | View source |
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