NCT02344238

Smart Capsule for Automatic Adherence Monitoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2015-01-22
• Last updated: 2018-11-08
• Results posted: 2018-10-09

Locations

1 site across 1 country: United States