N/A
Completed N=40
Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence
Medication Adherence
Source: ClinicalTrials.gov NCT02344251 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Medication Adherence — 94.8; 82.8 percentage of doses taken
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; 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Adherence |
94.8; 82.8 | — |
| SECONDARY Safety Assessment: Rates of Adverse Events Reported |
25; 15 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02344251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.