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Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

NCT ID: NCT02388386

Last Updated: 2020-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure Medication Compliance

Keywords

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Telemedicine Mobile Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PROTEUS-SENSOR

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scripps Clinic

OTHER

Sponsor Role collaborator

Scripps Translational Science Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjeev Bhavnani, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Clinic

Locations

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Scripps Health

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26873093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26890041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23014703 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26721413 (View on PubMed)

Other Identifiers

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PROTEUS-LVAD

Identifier Type: -

Identifier Source: org_study_id