Medication AdherenceNCT02344238
Smart Capsule for Automatic Adherence Monitoring
A study testing ID Capsule, Riboflavin and Prompts in people with Medication Adherence, run by Medical University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- ID Capsule, Riboflavin and Prompts
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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
- Being tested
- ID Capsule, Riboflavin, Prompts
- Keywords
- Medication compliance, Technology, Drug study
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID CapsuleOther
Capsule containing ingestible sensor
RiboflavinDietary supplement
50mg
PromptsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Capsules | Other | Receive standard capsules (no ID cap technology) with compliance measured by self-report, pill count, and riboflavin measurement. Receives: Dietary Supplement: Riboflavin |
| ID Capsules without Prompts | Other | Receive ID capsules, with compliance measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap. Receives: Other: ID Capsule; Dietary Supplement: Riboflavin |
| ID Capsules with Prompts | Other | 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. Receives: Other: ID Capsule; Dietary Supplement: Riboflavin; Behavioral: Prompts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
The primary outcome will be medication adherence as measured by percentage of doses taken among groups.
Measured: 30 days
Secondary outcomes (1)
Number of Participants Reporting Adverse Events
A secondary outcome will be safety and tolerability of ingestion of the ID Cap as measured by number of participants reporting adverse events in Group 1 who received standard capsules (no ID technology, study Arm 1) and Group 2 who received ID-Capsules (study Arms 2 and 3).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimee McRae-Clark, Medical University of South Carolina
- Investigators
- Aimee McRae-Clark, PharmD, BCPP, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344238
- Sponsor's protocol ID
- PRO00030913
- Status last verified
- Oct 2018
- First submitted
- 16 Jan 2015
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Capsule for Automatic Adherence Monitoring
- ClinicalTrials.gov ID
- NCT02344238
- Acronym / sponsor ID
- PRO00030913
- Conditions
- Medication Adherence
- Keywords
- Medication compliance, Technology, Drug study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Posted 9 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Capsules | Other | Dietary Supplement: RiboflavinReceive standard capsules (no ID cap technology) with compliance measured by self-report, pill count, and riboflavin measurement. |
| ID Capsules without Prompts | Other | Other: ID Capsule, Dietary Supplement: RiboflavinReceive ID capsules, with compliance measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap. |
| ID Capsules with Prompts | Other | Other: ID Capsule, Dietary Supplement: Riboflavin, Behavioral: PromptsReceive 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ID CapsuleCapsule containing ingestible sensor | Other | ID Capsules with Prompts, ID Capsules without Prompts |
| Riboflavin50mg | Dietary supplement | ID Capsules with Prompts, ID Capsules without Prompts, Standard Capsules |
| PromptsReminder 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. | Behavioural | ID Capsules with Prompts |
Primary outcome
Medication Adherence
Time frame: 30 days
The primary outcome will be medication adherence as measured by percentage of doses taken among groups.
1 secondary outcome
Number of Participants Reporting Adverse Events
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimee McRae-Clark, PharmD, BCPP principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ID Capsule, Riboflavin and Prompts in people with Medication Adherence, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.