Ignite Creation Date:
2024-05-06 @ 3:41 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02344251
Status:
COMPLETED
Last Update Posted:
2018-06-01
First Post:
2015-01-16
Brief Title:
Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Phase II Randomized Trial to Assess the Effectiveness and Safety of the ID-Cap System for Medication Ingestion Monitoring and Enhancing Adherence
Status:
COMPLETED
Status Verified Date:
2018-05
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 involving drug-dependent individuals 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 In this study we propose to assess the effectiveness and safety of the ID-Cap System a novel compliance measurement device in a healthy population
Detailed Description:
The primary objective of this clinical trial is to evaluate the acceptability tolerability and efficacy of the ID-Cap system in a healthy population The ID-Cap is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal GI tract
Participation in the study takes 3 visits over a period of approximately six weeks The first visit is a screening visit to determine if participants are eligible to participate After the initial assessment visit participants will be randomized to one of two groups Group 1 will have adherence measured by self-report pill count and urine riboflavin levels This group will not receive capsules containing ingestible sensors but will receive their medication in a bottle capped with a MEMS Track Cap which records when the medication bottle is opened and closed Group 2 will receive capsules containing an ingestible sensor and will have adherence measured by self-report pill count urine riboflavin levels as needed and data collected by an ID-Cap reader 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 They will also be using biometric identification technology to confirm subject identity specifically electrocardiogram ECG
After the initial screening visit participants will be required to attend two clinic visits during the six-week study a randomization visit and a one-week follow-up visit approximately one week after last medication dose
Participation in the study takes 3 visits over a period of approximately six weeks The first visit is a screening visit to determine if participants are eligible to participate After the initial assessment visit participants will be randomized to one of two groups Group 1 will have adherence measured by self-report pill count and urine riboflavin levels This group will not receive capsules containing ingestible sensors but will receive their medication in a bottle capped with a MEMS Track Cap which records when the medication bottle is opened and closed Group 2 will receive capsules containing an ingestible sensor and will have adherence measured by self-report pill count urine riboflavin levels as needed and data collected by an ID-Cap reader 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 They will also be using biometric identification technology to confirm subject identity specifically electrocardiogram ECG
After the initial screening visit participants will be required to attend two clinic visits during the six-week study a randomization visit and a one-week follow-up visit approximately one week after last medication dose
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