Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Sanjeev Bhavnani, MD; 8585545588; bhavnani.sanjeev@scrippshealth.org

Contact: Thomas J Heywood, MD; 8585545588; Heywood.James@scrippshealth.org

Locations

United States, California

Scripps Health; Recruiting

San Diego, California, United States, 92037

Sponsors and Collaborators

Scripps Translational Science Institute

Scripps Clinic

Investigators

• Principal Investigator: Sanjeev Bhavnani, MD; Scripps Clinic

More Information

Publications:

Bhavnani SP, Narula J, Sengupta PP. Mobile technology and the digitization of healthcare. Eur Heart J. 2016 May 7;37(18):1428-38. doi: 10.1093/eurheartj/ehv770. Epub 2016 Feb 11. Review.

DiCarlo LA, Weinstein RL, Morimoto CB, Savage GM, Moon GL, Au-Yeung K, Kim YA. Patient-Centered Home Care Using Digital Medicine and Telemetric Data for Hypertension: Feasibility and Acceptability of Objective Ambulatory Assessment. J Clin Hypertens (Greenwich). 2016 Sep;18(9):901-6. doi: 10.1111/jch.12787. Epub 2016 Feb 18.

DiCarlo L, Moon G, Intondi A, Duck R, Frank J, Hafazi H, Behzadi Y, Robertson T, Costello B, Savage G, Zdeblick M. A digital health solution for using and managing medications: wirelessly observed therapy. IEEE Pulse. 2012 Sep-Oct;3(5):23-6. doi: 10.1109/MPUL.2012.2205777.

Browne SH, Behzadi Y, Littlewort G. Let Visuals Tell the Story: Medication Adherence in Patients with Type II Diabetes Captured by a Novel Ingestion Sensor Platform. JMIR Mhealth Uhealth. 2015 Dec 31;3(4):e108. doi: 10.2196/mhealth.4292.

• Responsible Party: Scripps Translational Science Institute
• ClinicalTrials.gov Identifier: NCT02388386 History of Changes
• Other Study ID Numbers: PROTEUS-LVAD
• First Posted: March 17, 2015
• 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:

Heart Failure; Heart Diseases; Cardiovascular Diseases