Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence

Study Overview
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Brief Summary
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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; O'Brien 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
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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.

Official Title
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A Phase II Randomized Trial to Assess the Effectiveness and Safety of the ID-Cap System for Medication Ingestion Monitoring and Enhancing Adherence

Conditions
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Medication Adherence

Intervention / Treatment
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* Device: MEMS Cap
* Device: ID-Cap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be between the ages of 18 and 65 years If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial Must consent to random assignment, and be willing to commit to medication ingestion Must be able to read and provide informed consent Must function at an intellectual level sufficient to allow accurate completion of assessments Must have a Body Mass Index (BMI) below 35 Exclusion Criteria: Women who are pregnant, nursing, or plan to become pregnant during the course of the study Must not have evidence of a significant medical condition which may affect capsule passage through the gastrointestinal tract (including, but not limited to, Crohn's disease, small bowel tumors, intestinal adhesions, ulcerations, and radiation enteritis) Must not have a current major psychiatric disorder as these may interfere with assessment measures Must not be currently dependent on other substances, with the exception of nicotine or caffeine, within the past 60 days Hypersensitivity to riboflavin or any capsule component; Individuals with embedded electronic devices Patients who, in the investigator's opinion, would be unable to comply with study procedures or assessments, or would be unacceptable study candidates (e.g., poses threat to staff)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Adherence measured by MEMS Cap | Device: MEMS Cap<br>* MEMS Track Cap records when the medication bottle is opened and closed<br>|
| Other: Group 2<br>Adherence measured by ID-Cap technology. | Device: ID-Cap<br>* ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | The primary outcome will be medication adherence as measured by percentage of doses taken among groups. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment: Rates of Adverse Events Reported | A secondary outcome will be safety assessment as measured by the percentage of participants reporting adverse events. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug study, Medication compliance