Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence

NCT02344251 | Completed Results DMC

• 1 other identifier: PRO00033472
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication Adherence

Keywords

Drug study; Medication compliance

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)

• Safety Assessment: Rates of Adverse Events Reported

  30 days

Study Arms (2)

Group 1

OTHER

Adherence measured by MEMS Cap

Device: MEMS Cap

Group 2

OTHER

Adherence measured by ID-Cap technology.

Device: ID-Cap

Interventions

MEMS Cap DEVICE

MEMS Track Cap records when the medication bottle is opened and closed

Group 1

ID-Cap DEVICE

ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.

Group 2

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
• 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

You may not qualify if:

• 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)

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

Condition Hierarchy (Ancestors)

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

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: MUSC

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: HEALTH SERVICES RESEARCH
• 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: June 1, 2016
• Primary Completion: December 7, 2016
• Study Completion: December 1, 2017
• Last Updated: June 1, 2018
• Results First Posted: March 20, 2018

Record last verified: 2018-05

Locations

US (1)