Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence
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|ClinicalTrials.gov Identifier: NCT02344251|
Recruitment Status : Completed
First Posted : January 22, 2015
Results First Posted : March 20, 2018
Last Update Posted : June 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence||Device: MEMS Cap Device: ID-Cap||Not Applicable|
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 and/or 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||June 1, 2016|
|Actual Primary Completion Date :||December 7, 2016|
|Actual Study Completion Date :||December 1, 2017|
Adherence measured by MEMS Cap
Device: MEMS Cap
MEMS Track Cap records when the medication bottle is opened and closed
Adherence measured by ID-Cap technology.
ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.
- Medication Adherence [ Time Frame: 30 days ]The primary outcome will be medication adherence as measured by percentage of doses taken among groups.
- Safety Assessment: Rates of Adverse Events Reported [ Time Frame: 30 days ]A secondary outcome will be safety assessment as measured by the percentage of participants reporting adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344251
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Aimee McRae-Clark, PharmD, BCPP||Medical University of South Carolina|