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

A Phase II Randomized Trial to Assess the Effectiveness and Safety of the ID-Cap System for Medication Ingestion Monitoring and Enhancing Adherence

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Device: MEMS Cap; Device: ID-Cap

Detailed Description

The primary objective of this clinical trial is to evaluate the acceptability, tolerability, and efficacy of the ID-Cap system in a healthy population. The ID-Cap is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.

Participation in the study takes 3 visits over a period of approximately six weeks. The first visit is a screening visit to determine if participants are eligible to participate. After the initial assessment visit, participants will be randomized to one of two groups. Group 1 will have adherence measured by self-report, pill count, and urine riboflavin levels. This group will not receive capsules containing ingestible sensors, but will receive their medication in a bottle capped with a MEMS Track Cap, which records when the medication bottle is opened and closed. Group 2 will receive capsules containing an ingestible sensor and will have adherence measured by self-report, pill count, urine riboflavin levels as needed, and data collected by an ID-Cap reader. Participants randomized to this group will also receive reminder calls and/or text messages to ingest the study medication if a signal is not sent from the ID-Cap reader to the study team within one hour of the scheduled medication administration time. They will also be using biometric identification technology to confirm subject identity, specifically electrocardiogram (ECG).

After the initial screening visit, participants will be required to attend two clinic visits during the six-week study, a randomization visit and a one-week follow-up visit approximately one week after last medication dose.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Adherence measured by MEMS Cap	Device: MEMS Cap; MEMS Track Cap records when the medication bottle is opened and closed
Other: Group 2; Adherence measured by ID-Cap technology.	Device: ID-Cap; ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	The primary outcome will be medication adherence as measured by percentage of doses taken among groups.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment: Rates of Adverse Events Reported	A secondary outcome will be safety assessment as measured by the percentage of participants reporting adverse events.	30 days

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Aimee McRae-Clark, PharmD, BCPP, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 7, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 16, 2015
• First Submitted That Met QC Criteria: January 21, 2015
• First Posted (Estimate): January 22, 2015

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Medication compliance; Drug study
• Other Study ID Numbers: PRO00033472