Medication Adherence
Conditions
Keywords
Drug study, Medication compliance
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.
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.
Interventions
DEVICEMEMS Cap
MEMS Track Cap records when the medication bottle is opened and closed
DEVICEID-Cap
ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 30 days | The primary outcome will be medication adherence as measured by percentage of doses taken among groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment: Rates of Adverse Events Reported | 30 days | A secondary outcome will be safety assessment as measured by the percentage of participants reporting adverse events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MEMS Track Cap Compliance measured by MEMS Cap
MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed | 20 |
| ID Cap Tag Compliance measured by ID-Cap technology
ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | MEMS Track Cap | ID Cap Tag | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Region of Enrollment United States | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 5 / 20 | 3 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Medication Adherence
The primary outcome will be medication adherence as measured by percentage of doses taken among groups.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEMS Track Cap | Medication Adherence | 94.8 percentage of doses taken |
| ID Cap | Medication Adherence | 82.8 percentage of doses taken |
Secondary
Safety Assessment: Rates of Adverse Events Reported
A secondary outcome will be safety assessment as measured by the percentage of participants reporting adverse events.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEMS Track Cap | Safety Assessment: Rates of Adverse Events Reported | 25 percentage of participants reporting AEs |
| ID Cap | Safety Assessment: Rates of Adverse Events Reported | 15 percentage of participants reporting AEs |