Ignite Creation Date:
2024-05-06 @ 3:40 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02344238
Status:
COMPLETED
Last Update Posted:
2018-11-08
First Post:
2015-01-16
Brief Title:
Smart Capsule for Automatic Adherence Monitoring
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Smart Capsule for Automatic Adherence Monitoring
Status:
COMPLETED
Status Verified Date:
2018-10
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:
In pharmacotherapy trials in drug-dependent populations medication compliance is a significant issue as rates tend to be low and adherence to medication may predict improved outcomes Baros et al 2007 McRae et al 2004 OBrien et al 1996 Somoza et al 2010 However methods commonly used to determine compliance may result in inaccurate measurement of adherence It is therefore essential to develop measurement systems that not only accurately and objectively measure compliance but can also have the potential to increase compliance in difficult to treat disorders such as addiction In this study we propose to assess the acceptability tolerability and efficacy of the ID-Cap System a novel compliance measurement device in a healthy population
Detailed Description:
The primary objective of the clinical trial is to evaluate the acceptability tolerability and efficacy of the ID-Cap System in a healthy population
Participation in the study takes 10 visits over a period of approximately five weeks The first visit is a screening visit to determine if participants are eligible to participate After inclusion into the study participants will be randomized into one of three groups Participants randomized to Group 1 will have compliance measured by patient reports pill count and riboflavin measurement Participants randomized to Group 2 will have compliance measured by patient reports pill count riboflavin measurement and data collected by the e-Tect reader Participants randomized to Group 3 will also have compliance measured by patient reports pill count riboflavin measurement and data collected by the ID-Cap reader However participants randomized to this group will also receive reminder calls andor text messages to ingest the study medication if a signal is not sent from the ID-Cap reader to the study team within one hour of the scheduled medication administration time
After the initial screening visit participants will present to the clinic twice weekly to complete self-reports of compliance provide urine samples for riboflavin assessment and be assessed for adverse effects
They will also be asked to attend one follow-up visit to include abdominal x-ray in order to confirm passage of the capsules
Participation in the study takes 10 visits over a period of approximately five weeks The first visit is a screening visit to determine if participants are eligible to participate After inclusion into the study participants will be randomized into one of three groups Participants randomized to Group 1 will have compliance measured by patient reports pill count and riboflavin measurement Participants randomized to Group 2 will have compliance measured by patient reports pill count riboflavin measurement and data collected by the e-Tect reader Participants randomized to Group 3 will also have compliance measured by patient reports pill count riboflavin measurement and data collected by the ID-Cap reader However participants randomized to this group will also receive reminder calls andor text messages to ingest the study medication if a signal is not sent from the ID-Cap reader to the study team within one hour of the scheduled medication administration time
After the initial screening visit participants will present to the clinic twice weekly to complete self-reports of compliance provide urine samples for riboflavin assessment and be assessed for adverse effects
They will also be asked to attend one follow-up visit to include abdominal x-ray in order to confirm passage of the capsules
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None