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Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

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ClinicalTrials.gov Identifier: NCT02388386
Recruitment Status : Unknown
Verified November 2016 by Scripps Translational Science Institute.
Recruitment status was:  Recruiting
First Posted : March 17, 2015
Last Update Posted : November 23, 2016
Sponsor:
Collaborator:
Scripps Clinic
Information provided by (Responsible Party):
Scripps Translational Science Institute

Brief Summary:
The investigators aim to develop a novel and wireless method for monitoring medication adherence among heart failure patients with left ventricular assist devices (LVADs). Proteus Digital™ has developed an ingestible and bio-absorbable micro-sensor as a strategy to monitor medication compliance. The edible sensor has at its core a silicon-based integrated circuit measuring 1.0 mm x 0.45 mm and is imbedded on a pill. Once ingested, this circuit is activated by gastric acid resulting in an electrochemical redox reaction and an electrical charge that is transmitted to a patch worn over the abdomen and wirelessly to a portable device such as a smart phone. This strategy of medication adherence differs from conventional adherence monitoring including pill counting and patient-recall by precisely tracking medication ingestion.

Condition or disease Intervention/treatment Phase
Heart Failure Medication Compliance Device: PROTEUS-SENSOR Phase 1

Detailed Description:
The objectives are to assess the efficacy and safety of the Proteus Digital™ micro-sensor in an exploratory investigation among heart failure patients with LVADs. Medication adherence, specifically to anticoagulation is critically important in the post-implant period to maintain LVAD function and to decrease thromboembolic complications; however, commonly results in significant bleeding resulting in significant morbidity and mortality. In addition, the anticipated degree of anticoagulation is unpredictable after LVAD implantation due to factors related to changes in hepatic blood flow and endothelial dysfunction. Enrolling 10 patients will provide results into the function of micro-sensor and to provide a preliminary assessment of sensor-based activity, signal strength and signal duration in LVAD recipients. Participants will be enrolled during an in-patient hospitalization to assess the efficacy and safety of the device in a monitored setting.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Wireless Observed Therapy With an Ingestible Micro-Sensor Among Patients With Heart Failure and Left Ventricular Assist Devices
Study Start Date : February 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: PROTEUS-SENSOR
The current study is a prospective interventional design with a single experimental arm. The intervention consists of two components: an edible sensor and a wearable receiver health monitor.
Device: PROTEUS-SENSOR
An edible sensor system, Proteus Digital™ has been developed for electronically confirming medication adherence, gathering physiologic metrics and communicating these data to patients. The system consists of two major components: an edible sensor and a wearable receiver health monitor. An electrical signal is activated upon ingestion of the Proteus Digital micro-sensor with transmission of this signal to a receiving abdominal patch to quantify medication compliance.




Primary Outcome Measures :
  1. System Performance - Positive Detection Accuracy [ Time Frame: 30 minutes after ingestion ]
    Primary outcome measure of system performance will be estimated by the positive detection accuracy, defined as the number of ingestible sensors detected divided by those ingested, and the identification accuracy, defined as the number of ingestible sensors identified with a correct signature divided by those detected.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From time of ingestion to 30 minutes after ingestion ]

    Specific safety metrics will consist of the following composite outcome:

    1. Safety as measured by vital signs
    2. Cardiac rhythm monitoring review for arrhythmias
    3. LVAD device interrogation for changes in device parameters
    4. Implantable cardioverter defibrillator interrogation for arrhythmia occurrence
    5. Documentation of any symptoms

  2. Biofeedback (perceptions of the system will be assessed using a post-study questionnaire) [ Time Frame: Participants will be followed for the duration of the hospital stay or 3-days which ever is shorter ]
    At the end of the study, perceptions of the system will be assessed using a post-study questionnaire. Questions will be answered using a Likert scale from 1 (strongly agree) to 10 (strongly disagree). Participants are also required to provide qualitative feedback about their experience using the system.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients undergoing LVAD implantation for end-stage heart failure or admitted from the out-patient setting

Exclusion Criteria:

  • Unable to consistently consume oral intake
  • Hemodynamic instability defined as hypotension requiring intravenous vasoactive medications or arrhythmias requiring intravenous antiarrhythmics or oral antiarrhythmics for rhythm stabilization
  • Gastrointestinal bleeding requiring intravenous gastric acid secretion inhibitors

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): NCT02388386


Contacts
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Contact: Sanjeev Bhavnani, MD 8585545588 bhavnani.sanjeev@scrippshealth.org
Contact: Thomas J Heywood, MD 8585545588 Heywood.James@scrippshealth.org

Locations
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United States, California
Scripps Health Recruiting
San Diego, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Scripps Clinic
Investigators
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Principal Investigator: Sanjeev Bhavnani, MD Scripps Clinic

Publications:
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Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT02388386     History of Changes
Other Study ID Numbers: PROTEUS-LVAD
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available upon request
Keywords provided by Scripps Translational Science Institute:
Telemedicine
Mobile Health
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases