Smart Capsule for Automatic Adherence Monitoring

NCT ID: NCT02344238

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-06-30

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.

Detailed Description

The primary objective of the clinical trial is to evaluate the acceptability, tolerability, and efficacy of the ID-Cap System in a healthy population.

Participation in the study takes 10 visits over a period of approximately five weeks. The first visit is a screening visit to determine if participants are eligible to participate. After inclusion into the study, participants will be randomized into one of three groups. Participants randomized to Group 1 will have compliance measured by patient reports, pill count, and riboflavin measurement. Participants randomized to Group 2 will have compliance measured by patient reports, pill count, riboflavin measurement, and data collected by the e-Tect reader. Participants randomized to Group 3 will also have compliance measured by patient reports, pill count, riboflavin measurement, and data collected by the ID-Cap reader. However, 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.

After the initial screening visit, participants will present to the clinic twice weekly to complete self-reports of compliance, provide urine samples for riboflavin assessment, and be assessed for adverse effects.

They will also be asked to attend one follow-up visit to include abdominal x-ray in order to confirm passage of the capsules.

Conditions

Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard Capsules

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

Group Type: OTHER

Riboflavin

Intervention Type: DIETARY_SUPPLEMENT

50mg

ID Capsules without Prompts

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

Group Type: OTHER

ID Capsule

Intervention Type: OTHER

Capsule containing ingestible sensor

Riboflavin

Intervention Type: DIETARY_SUPPLEMENT

50mg

ID Capsules with Prompts

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.

Group Type: OTHER

ID Capsule

Intervention Type: OTHER

Capsule containing ingestible sensor

Riboflavin

Intervention Type: DIETARY_SUPPLEMENT

50mg

Prompts

Intervention Type: 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.

Interventions

ID Capsule

Capsule containing ingestible sensor

Intervention Type: OTHER

Riboflavin

50mg

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Aimee McRae-Clark

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aimee McRae-Clark, PharmD, BCPP

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

PRO00030913

Identifier Type: -

Identifier Source: org_study_id