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 Grazoprevir/Elbasvir
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adherence
- Sponsor
- Saint Michael's Medical Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Use of Portal724-MEMS Service on Medication Adherence in the Treatment of Hepatitis C in Patients, Defined as Compliance to Regimen 95% of the Time.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 patient's 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 3.2 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 patient's 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
Investigators
Jihad Slim, MD
Chief and Program Director, Infectious Diseases
Saint Michael's Medical Center
Eligibility Criteria
Inclusion Criteria
- •Male or female 18 years old and above.
- •HCV treatment naïve or HCV trreatment experienced
- •HCV RNA PCR \> 10,000 IU/L
- •Confirmed infection with Hepatitis C virus (HCV) by HCV serum antibody assay and by HCV Ribonucleic Acid (RNA) Polymerase Chain Reaction (PCR) and Confirmed chronicity with 2 PCR's 6 months apart.
- •Patients with HCV Genotype 1, 4
- •Patients are candidates for treatment of HCV with oral Direct-Acting Agents (DAA)
- •understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent
Exclusion Criteria
- •Patient not willing to sign written informed consent
- •Patients deemed not suitable for HCV treatment as deemed by the treating physician at the liver center
- •Patients with decompensated liver cirrhosis, defined as follows:
- •Liver biopsy within the last year showing Scheuer Stage 4 or transient elastography (Fibroscan®) in the last year with a reading of \>12.5 kPa; AND
- •Any clinical sign of hepatic decompensation such as ascites (fluid in the abdomen), jaundice (yellowing of eyes and skin), esophageal varices with bleeding (enlarged veins of the esophagus seen on endoscopy) or hepatic encephalopathy (tremors, confusion, sleepiness)
- •Co-Infection with the Hepatitis B virus
- •Any liver disease of non-HCV etiology such as Hemochromatosis, Wilson's Disease, Alcoholic liver disease or Non-Alcoholic Steato-Hepatitis (NASH)
- •Hepatocellular carcinoma or any other malignancy
- •Untreated psychiatric conditions such as major depression, schizophrenia, bipolar disorder which in the opinion of the Principal Investigator will not interfere with protocol visit and/or procedures
- •Current and untreated substance abuse (cocaine, opiates, alcohol, marijuana, other recreational drugs, controlled substances)
Outcomes
Primary Outcomes
Use of Portal724-MEMS Service on Medication Adherence in the Treatment of Hepatitis C in Patients, Defined as Compliance to Regimen 95% of the Time.
Time Frame: 1 year
Number of Participants with Compliance to Regimen 95% of the Time Due to Portal724-MEMS Service