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NCT02740556 · ClinicalTrials.gov registry record · NA
Evaluation of HepCure Toolkit to Improve Harvoni Adherence
A NA study of Hepatitis C and Medication Adherence, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT02740556 is a NA study of Hepatitis C and Medication Adherence that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 71 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02740556, a NA study of Hepatitis C and Medication Adherence, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study Summary
There is limited data outside of clinical trials on adherence to once daily ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication adherence including untreated psychiatric illness and substance use disorders, cognitive impairment, and low health literacy. The goal of this study is to evaluate the baseline level of adherence to ledipasvir/sofosbuvir in a real-world clinic population and compare this to the level of adherence in patients provided with additional adherence support. Medication adherence in this study will be evaluated using AdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. Using cellular technology, AdhereTech can be used passively to collect data on when a medication is taken, when a refill is needed, and how often the bottle is opened. AdhereTech also can be used actively to monitor adherence and provide feedback to subjects using the device. When actively monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take their medication (see attached PowerPoint presentation). HepCure is a web-based tool kit in the form of a dashboard for medical providers (MDs and NPs) and an application (or "app") for patients. The app allows patients to become active participants in their treatment by enabling them to set medication reminders, record doses taken, and communicate their adherence to their medical provider using the provider dashboard.
Conditions Studied
Interventions
- OTHER HepCure ToolKit
- DEVICE AdhereTech Active Features
- OTHER AdhereTech Passive Monitoring
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2016-02 |
| Est. Completion | 2019-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02740556
The ClinicalTrials.gov registry entry for NCT02740556 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (96% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which HepCure ToolKit is the first listed.
NCT02740556 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02740556 about?
NCT02740556 is a clinical study titled "Evaluation of HepCure Toolkit to Improve Harvoni Adherence". There is limited data outside of clinical trials on adherence to once daily ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication adherence including untreated psychiatric illness and substance use disorders, cognitive impairment, and low health literacy. The goal o...
What is the current status of trial NCT02740556?
This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2016-02. Estimated completion is 2019-03-31.
What conditions does trial NCT02740556 study?
This clinical trial studies the following conditions: Hepatitis C, Medication Adherence.
What interventions are being tested in trial NCT02740556?
The interventions under investigation include: HepCure ToolKit (OTHER), AdhereTech Active Features (DEVICE), AdhereTech Passive Monitoring (OTHER).
Who is sponsoring clinical trial NCT02740556?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02740556 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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