Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

• Sponsor: Scripps Translational Science Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02388386
• Collaborator: Scripps Clinic (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 14
• Patients Per Site Per Month: 0.7

Study Details

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	N/A

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
• Actual Enrollment: 10 participants
• Allocation: N/A
• 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: Feb 1, 2015
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 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 [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

Secondary Outcome Measures

1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [From time of ingestion to 30 minutes after ingestion]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Scripps Health	San Diego	California	United States	92037

Sponsors and Collaborators

• Scripps Translational Science Institute
• Scripps Clinic

Investigators

• Principal Investigator: Sanjeev Bhavnani, MD, Scripps Clinic

Study Documents (Full-Text)

None provided.

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.
• 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.
• 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.
• 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.

• Responsible Party: Scripps Translational Science Institute
• ClinicalTrials.gov Identifier: NCT02388386
• Other Study ID Numbers: PROTEUS-LVAD
• First Posted: Mar 17, 2015
• Last Update Posted: Nov 17, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Scripps Translational Science Institute: Telemedicine; Mobile Health
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	PROTEUS-SENSOR
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	PROTEUS-SENSOR
Arm/Group Description	10 consecutive heart failure patients with continuous flow left ventricular devices
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72 (5)
Sex: Female, Male (Count of Participants)
Female	3 30%
Male	7 70%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	System Performance - Positive Detection Accuracy
Description	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
Time Frame	30 minutes after ingestion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Outcome Measure
Arm/Group Description	Positive detection rate of 80%
Measure Participants	10
Measure Ingestions	40
Number [percentage of ingestions]	80

2. Secondary Outcome

Title	Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description	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
Time Frame	From time of ingestion to 30 minutes after ingestion

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Vital Signs	Cardiac Rhythm	LVAD Device Interrogation	Implantable Cardioverter Defibrillator Interrogation
Arm/Group Description	Safety as measured by vital signs	Cardiac rhythm monitoring for arrhythmias	Change in LVAD device parameters	Assessment of cardiac arrhythmias by ICD interrogation
Measure Participants	10	10	10	10
Count of Participants [Participants]	0 0%	0 NaN	0 NaN	0 NaN

Adverse Events

Time Frame	2 hours
Adverse Event Reporting Description	Adverse events defined as nausea, abdominal pain after ingestion, skin irritation due to the adhesive patch, arrhythmia
Arm/Group Title	PROTEUS-SENSOR
Arm/Group Description	10 consecutive heart failure patients with continuous flow left ventricular devices
All Cause Mortality
	PROTEUS-SENSOR
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	PROTEUS-SENSOR
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	PROTEUS-SENSOR
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.