Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

Heart Failure Clinical Trial

Official title:

Pilot Study of Wireless Observed Therapy With an Ingestible Micro-Sensor Among Patients With Heart Failure and Left Ventricular Assist Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388386
• Other study ID #: PROTEUS-LVAD
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2020
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Medication Compliance

Intervention

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.

Locations

Country	Name	City	State
United States	Scripps Health	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	Scripps Clinic

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Performance - Positive Detection Accuracy	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	30 minutes after ingestion
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Specific safety metrics will consist of the following composite outcome: Safety as measured by vital signs; Cardiac rhythm monitoring review for arrhythmias; LVAD device interrogation for changes in device parameters; Implantable cardioverter defibrillator interrogation for arrhythmia occurrence	From time of ingestion to 30 minutes after ingestion