Ignite Creation Date:
2024-05-06 @ 8:27 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02740556
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2016-04-12
Brief Title:
Evaluation of HepCure Toolkit to Improve Harvoni Adherence
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Evaluation of HepCure Toolkit to Improve Harvoni Adherence
Status:
COMPLETED
Status Verified Date:
2020-03
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:
There is limited data outside of clinical trials on adherence to once daily ledipasvirsofosbuvir 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 ledipasvirsofosbuvir 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 phonetextemail 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
Detailed Description:
Primary Objectives
The study will be conducted in two phases with the following aims 1 To passively assess the adherence to hepatitis C virus HCV treatment with ledipasvirsofosbuvir using a wireless pill monitoring device in 33 patients Phase 1 months 1-3 2 To test the impact on adherence of using the active wireless pill monitoring device in conjunction with the HepCure web-based tool kit in 66 patients Phase 2 months 4-9 Participants in phase 2 will be randomized 11 to one of two conditions a Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard AdhereTech passively monitoring adherence b Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard AdhereTech actively monitoring adherence chimes and reminders enabled
Secondary Objectives
The study design allows us to compare the additive effect on adherence of the HepCure provider toolkit and the HepCure provider toolkit active AdhereTech reminder system
Primary Endpoints
The primary study endpoints are taking and timing adherence as assessed by electronic monitoring There are numerous methods of assessing adherence to medication They each have their strengths and weaknesses and some are only feasible in the research but not clinical setting The most commonly used methods of assessing adherence are 1 provider assessment 2 structured self-report 3 pharmacy refill data 4 electronic monitoring 5 pill counts and 6 directly observed therapy Electronic monitoring technology has been widely used in research studies of HIV medication adherence and is regarded by many as the most accurate method of assessing medication adherence Weiss et al 2009 In this method the medication bottle cap has a microchip which records all openings and closings of the bottle This microchip provides the researcher with a precise record of the date and time of each bottle opening This method has been shown to be closely associated with random home pill count Bangsberg et al 2001a viral suppression Bangsberg et al 2000 Paterson et al 2000 Arnsten et al 2001 Walsh et al 2002b Moss et al 2004 and drug resistance Walsh et al 2002b Studies have consistently found that provider assessment of adherence is poor Bangsberg et al 2001b Gross et al 2002 and Miller et al 2002 Self-reported adherence tends to provide an over-estimate of actual adherence Weiss et al 2009 Pharmacy refill data is best employed when patients use one pharmacy for all prescriptions pharmacy data are easily accessible to the clinician by computer and prescriptions are not automatically delivered without the patient needing to request them or pick them up Patients in clinical research studies are often asked to bring their medication to study visits so that the change in the number of pills accounting for refills since the last visit can be used to assess adherence Potential problems associated with these announced pill counts are that patients may forget to bring their medication to study visits and nonadherent patients may throw out pills prior to the visit pill dumps to avoid being labeled nonadherent While directly observed therapy DOT provides a highly accurate assessment of adherence the cost and intrusiveness of observing all doses of medication ingestion make it an impractical method of ARV adherence assessment except in very specific settings eg prisons or nursing homes
The study will be conducted in two phases with the following aims 1 To passively assess the adherence to hepatitis C virus HCV treatment with ledipasvirsofosbuvir using a wireless pill monitoring device in 33 patients Phase 1 months 1-3 2 To test the impact on adherence of using the active wireless pill monitoring device in conjunction with the HepCure web-based tool kit in 66 patients Phase 2 months 4-9 Participants in phase 2 will be randomized 11 to one of two conditions a Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard AdhereTech passively monitoring adherence b Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard AdhereTech actively monitoring adherence chimes and reminders enabled
Secondary Objectives
The study design allows us to compare the additive effect on adherence of the HepCure provider toolkit and the HepCure provider toolkit active AdhereTech reminder system
Primary Endpoints
The primary study endpoints are taking and timing adherence as assessed by electronic monitoring There are numerous methods of assessing adherence to medication They each have their strengths and weaknesses and some are only feasible in the research but not clinical setting The most commonly used methods of assessing adherence are 1 provider assessment 2 structured self-report 3 pharmacy refill data 4 electronic monitoring 5 pill counts and 6 directly observed therapy Electronic monitoring technology has been widely used in research studies of HIV medication adherence and is regarded by many as the most accurate method of assessing medication adherence Weiss et al 2009 In this method the medication bottle cap has a microchip which records all openings and closings of the bottle This microchip provides the researcher with a precise record of the date and time of each bottle opening This method has been shown to be closely associated with random home pill count Bangsberg et al 2001a viral suppression Bangsberg et al 2000 Paterson et al 2000 Arnsten et al 2001 Walsh et al 2002b Moss et al 2004 and drug resistance Walsh et al 2002b Studies have consistently found that provider assessment of adherence is poor Bangsberg et al 2001b Gross et al 2002 and Miller et al 2002 Self-reported adherence tends to provide an over-estimate of actual adherence Weiss et al 2009 Pharmacy refill data is best employed when patients use one pharmacy for all prescriptions pharmacy data are easily accessible to the clinician by computer and prescriptions are not automatically delivered without the patient needing to request them or pick them up Patients in clinical research studies are often asked to bring their medication to study visits so that the change in the number of pills accounting for refills since the last visit can be used to assess adherence Potential problems associated with these announced pill counts are that patients may forget to bring their medication to study visits and nonadherent patients may throw out pills prior to the visit pill dumps to avoid being labeled nonadherent While directly observed therapy DOT provides a highly accurate assessment of adherence the cost and intrusiveness of observing all doses of medication ingestion make it an impractical method of ARV adherence assessment except in very specific settings eg prisons or nursing homes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GS-IN-US-337-3933 | OTHER_GRANT | Gilead Sciences | None |