Smart Capsule for Automatic Adherence Monitoring
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/10/2018 |
| Start Date: | July 2015 |
| End Date: | June 2016 |
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.
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.
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.
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.
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)
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Aimee L McRae-Clark, PharmD, BCPP
Phone: 843-792-0484
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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