AdherenceNCT02858050
Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications
An observational study of Adherence, run by Saint Michael's Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence
- What is being tested?
- Portal-724 MEMs Cap
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2016to 25 Jan 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Treatment-naïve and treatment-experienced genotype 1 or 4 HCV patients with or without compensated cirrhosis will be enrolled in this study.
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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.
- Poor venous access that precludes routine peripheral blood sampling required for this trial.
- History of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease).
- History of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures
- Medical/surgical conditions that may result in a need for hospitalization during the period of the study
- any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, TNF antagonists, or other immunosuppressant drugs during the course of the trial
- has exclusionary laboratory values as listed below: Noncirrhotic/Cirrhotic Subjects Creatinine clearance < 50 mL/min Hemoglobin <9.5 g/dL for both male and female subjects Platelets <50 x 103/μL serum albumin < 3.0 g/dL INR >1.7, unless subject has a stable INR on an anticoagulant regimen. HbA1c >10% ALT >10XULN AST >10XULN
- is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Michael's Medical Center
Newark, New Jersey, 07102
About this study
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 Grazoprevir/Elbasvir
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
Read the 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
- Conditions
- Adherence
- Being tested
- Portal-724 MEMs Cap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal-724 MEMs CapDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Portal-724 MEMs Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start9 Sep 2016
- Primary completion30 Nov 2017
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Michael's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Jihad Slim, MD, Saint Michael's Medical Center
- Investigators
- Jihad Slim, MD, Principal investigator, Saint Micahel's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858050
- Sponsor's protocol ID
- 13/16
- Status last verified
- Apr 2023
- First submitted
- 3 Aug 2016
- Last updated
- 13 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Grazoprevir/Elbasvir
- ClinicalTrials.gov ID
- NCT02858050
- Acronym / sponsor ID
- 13/16
- Conditions
- Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saint Michael's Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Posted 11 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEMs Cap Real-Time Monitoring | – | Device: Portal-724 MEMs CapGroup 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 |
| MEMs Cap Without Real-Time Monitoring | – | Device: Portal-724 MEMs CapGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment-naïve and treatment-experienced genotype 1 or 4 HCV patients with or without compensated cirrhosis will be enrolled in this study.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portal-724 MEMs Cap | Device | MEMs Cap Real-Time Monitoring, MEMs Cap Without Real-Time Monitoring |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihad Slim, MD principal investigator
Saint Micahel's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence, run by Saint Michael's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.