Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications

NCT02858050 | Completed Results

• 1 other identifier: 13/16
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  Number of Participants with Compliance to Regimen 95% of the Time Due to Portal724-MEMS Service

  1 year

Study Arms (2)

MEMs Cap Real-Time Monitoring

Group 1 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and will transmit data in real-time

Device: Portal-724 MEMs Cap

MEMs Cap Without Real-Time Monitoring

Group 2 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and data will be downloaded at each study visit while taking hepatitis C medications

Device: Portal-724 MEMs Cap

Interventions

Portal-724 MEMs Cap DEVICE

MEMs Cap Real-Time Monitoring; MEMs Cap Without Real-Time Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Treatment-naïve and treatment-experienced genotype 1 or 4 HCV patients with or without compensated cirrhosis will be enrolled in this study.

You may qualify if:

• 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

You may not qualify if:

• 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)
• Patient is pregnant or breastfeeding.
• Patients unwilling to use cellular phones
• Patients unwilling to follow specific instructions for medication intake
• Patient has any of the following conditions:
• Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.

Sponsors & Collaborators

• Saint Michael's Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

Limitations and Caveats

A limitation to our pilot study might be the small sample size and a larger study might detect a difference in adherence.

Results Point of Contact

• Title: Jihad Slim, MD
• Organization: Saint Michael's Medical Center

jsmdsmmc@gmail.com

9738772663

Study Officials

• Jihad Slim, MD

  Saint Micahel's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief and Program Director, Infectious Diseases

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 8, 2016
• Study Start: September 9, 2016
• Primary Completion: November 30, 2017
• Study Completion: January 25, 2018
• Last Updated: April 13, 2023
• Results First Posted: December 11, 2018

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)