Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02858050
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2016-08-03
Brief Title:
Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications
Sponsor:
Saint Michaels Medical Center
Organization:
Saint Michaels Medical Center
Study Overview
Official Title:
A Randomized Parallel-group Pilot Study on the Effect of Using the Portal724-Medication Electronic Medication System MEMS Smart Cap With Real-time Medication Adherence Among Patients Being Treated With GrazoprevirElbasvir
Status:
COMPLETED
Status Verified Date:
2023-04
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:
None
Brief Summary:
The study will look at real-time adherence monitoring with Portal-724 MEMS cap It integrates medication bottle Smart Cap Pill Dispenser Embedded Computer Embedded Cellular Modem and Tamper Proof apparatus This device is capable of transmitting pill dispensing events from the patients home to the Cloud over Cellular and IP networks The transmission is done in real time if cellular coverage is above 1-bar but if the cell signal is not available or if the signal is below the threshold then the device Store-and-Forward feature is automatically activated The patient will be randomized to real-time monitoring or to have monitoring data download monthly at each study visit while taking hepatitis C medications
Detailed Description:
Hepatitis C virus HCV infection is a very important health problem worldwide Majority of the estimated 160 million people infected globally are unaware of their affliction 1 It is a leading cause of chronic hepatitis liver cirrhosis and hepatocellular carcinoma In the United States alone HCV infection is the most common chronic blood-borne infection affecting about 32 million individuals The study will look at real-time adherence monitoring with Portal-724 MEMS cap It integrates medication bottle Smart Cap Pill Dispenser Embedded Computer Embedded Cellular Modem and Tamper Proof apparatus This device is capable of transmitting pill dispensing events from the patients home to the Cloud over Cellular and IP networks The transmission is done in real time if cellular coverage is above 1-bar but if the cell signal is not available or if the signal is below the threshold then the device Store-and-Forward feature is automatically activated The patient will be randomized to real-time monitoring or to have monitoring data download monthly at each study visit while taking hepatitis C medications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None