Smart Capsule for Automatic Adherence Monitoring

Study Overview
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Brief Summary
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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; O'Brien 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
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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 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. 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.

Official Title
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Smart Capsule for Automatic Adherence Monitoring

Conditions
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Medication Adherence

Intervention / Treatment
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* Other: ID Capsule
* Dietary Supplement: Riboflavin
* Behavioral: Prompts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be between the ages of 18 and 65 years Must have BMI within range of 18-30 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 Exclusion Criteria: Women who are pregnant, nursing, or plan to become pregnant during the course of the study, as abdominal X-rays will be completed on all participants 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 past or current psychotic or bipolar disorder Must not be currently dependent on substances, with the exception of nicotine or caffeine, within the past 60 days Hypersensitivity to adhesive, riboflavin, or any capsule component 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Capsules<br>Receive standard capsules (no ID cap technology) with compliance measured by self-report, pill count, and riboflavin measurement. | Dietary Supplement: Riboflavin<br>* 50mg<br>|
| Other: ID Capsules without Prompts<br>Receive ID capsules, with compliance measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap. | Other: ID Capsule<br>* Capsule containing ingestible sensor<br>Dietary Supplement: Riboflavin<br>* 50mg<br>|
| Other: ID Capsules with Prompts<br>Receive ID capsules, with compliance measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap. This arm will also receive prompts (reminder calls and/or text messages) to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time. | Other: ID Capsule<br>* Capsule containing ingestible sensor<br>Dietary Supplement: Riboflavin<br>* 50mg<br>Behavioral: Prompts<br>* Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.<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 |
| --- | --- | --- |
| Number of Participants Reporting Adverse Events | A secondary outcome will be safety and tolerability of ingestion of the ID Cap as measured by number of participants reporting adverse events in Group 1 who received standard capsules (no ID technology, study Arm 1) and Group 2 who received ID-Capsules (study Arms 2 and 3). | 30 days | 

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