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Smart Capsule for Automatic Adherence Monitoring

NCT02344238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-11-08

Study results available
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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.

Conditions

  • Medication Adherence

Interventions

OTHER

ID Capsule

Capsule containing ingestible sensor

DIETARY_SUPPLEMENT

Riboflavin

50mg

BEHAVIORAL

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.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Aimee McRae-Clark, PharmD, BCPP · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-04-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344238 on ClinicalTrials.gov