Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335758
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-12-11
Brief Title:
Non-randomized Observational Study to Evaluate ReX in the Management of Solid Oral Medication
Sponsor:
Dosentrx Ltd
Organization:
Dosentrx Ltd
Study Overview
Official Title:
Non-randomized Observational Study to Collate Data Regarding the Safety Efficacy and Satisfaction of ReX in the Management of Solid Oral Medications
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RegStud
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None