Smart Capsule for Automatic Adherence Monitoring

NCT02344238 | Completed Results DMC

• 1 other identifier: PRO00030913
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Medication compliance; Technology; Drug study

Outcome Measures

Primary Outcomes (1)

• Medication Adherence

  The primary outcome will be medication adherence as measured by percentage of doses taken among groups.

  30 days

Secondary Outcomes (1)

• Number of Participants Reporting Adverse Events

  30 days

Study Arms (3)

Standard Capsules

OTHER

Receive standard capsules (no ID cap technology) with compliance measured by self-report, pill count, and riboflavin measurement.

Dietary Supplement: Riboflavin

ID Capsules without Prompts

OTHER

Receive ID capsules, with compliance measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap.

Other: ID Capsule; Dietary Supplement: Riboflavin

ID Capsules with Prompts

OTHER

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; Dietary Supplement: Riboflavin; Behavioral: Prompts

Interventions

ID Capsule OTHER

Capsule containing ingestible sensor

ID Capsules with Prompts; ID Capsules without Prompts

Riboflavin DIETARY_SUPPLEMENT

50mg

ID Capsules with Prompts; ID Capsules without Prompts; Standard Capsules

Prompts BEHAVIORAL

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.

ID Capsules with Prompts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Limitations and Caveats

Limited generalizability- participants were primarily MUSC students \& staff. The ID Cap system is only available for adherence measurement for solid oral dosage medications. Potential for user error due to the electronic nature of the ID Cap system.

Results Point of Contact

• Title: Dr. Aimee McRae-Clark
• Organization: Medical University of South Carolina

mcraeal@musc.edu

Study Officials

• Aimee McRae-Clark, PharmD, BCPP

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 22, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 8, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-10

Locations

US (1)