N/A
Completed N=60
Smart Capsule for Automatic Adherence Monitoring
Medication Adherence
Source: ClinicalTrials.gov NCT02344238 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Medication Adherence — 88.1; 96.6; 94.4 percentage of doses taken (pill count)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Adherence |
88.1; 96.6; 94.4 | — |
| SECONDARY Number of Participants Reporting Adverse Events |
10; 20 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02344238). 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.