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Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence

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ClinicalTrials.gov Identifier: NCT02344251
Recruitment Status : Completed
First Posted : January 22, 2015
Results First Posted : March 20, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Medication Adherence Device: MEMS Cap Device: ID-Cap Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Phase II Randomized Trial to Assess the Effectiveness and Safety of the ID-Cap System for Medication Ingestion Monitoring and Enhancing Adherence
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : December 7, 2016
Actual Study Completion Date : December 1, 2017

Arm Intervention/treatment
Group 1
Adherence measured by MEMS Cap
Device: MEMS Cap
MEMS Track Cap records when the medication bottle is opened and closed

Group 2
Adherence measured by ID-Cap technology.
Device: ID-Cap
ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.




Primary Outcome Measures :
  1. Medication Adherence [ Time Frame: 30 days ]
    The primary outcome will be medication adherence as measured by percentage of doses taken among groups.


Secondary Outcome Measures :
  1. Safety Assessment: Rates of Adverse Events Reported [ Time Frame: 30 days ]
    A secondary outcome will be safety assessment as measured by the percentage of participants reporting adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344251


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Aimee McRae-Clark, PharmD, BCPP Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Aimee McRae-Clark, Medical University of South Carolina:
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Responsible Party: Aimee McRae-Clark, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02344251    
Other Study ID Numbers: PRO00033472
First Posted: January 22, 2015    Key Record Dates
Results First Posted: March 20, 2018
Last Update Posted: June 1, 2018
Last Verified: May 2018
Keywords provided by Aimee McRae-Clark, Medical University of South Carolina:
Drug study
Medication compliance