Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

NCT02388386 | Completed Results DMC

• 1 other identifier: PROTEUS-LVAD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Medication Compliance

Keywords

Telemedicine; Mobile Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  From time of ingestion to 30 minutes after ingestion

Study Arms (1)

PROTEUS-SENSOR

EXPERIMENTAL

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

Interventions

PROTEUS-SENSOR 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.

PROTEUS-SENSOR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scripps Translational Science Institute: lead
• Scripps Clinic: collaborator

Study Sites (1)

Scripps Health

San Diego, California, 92037, United States

Location

Related 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.

  PMID: 26873093 BACKGROUND

• 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.

  PMID: 26890041 BACKGROUND

• 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.

  PMID: 23014703 BACKGROUND

• 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.

  PMID: 26721413 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Medication Adherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Sanjeev Bhavanni MD
• Organization: Scripps Clinic Medical Group

bhavnani.sanjeev@scrippshealth.org

6196601842

Study Officials

• Sanjeev Bhavnani, MD

  Scripps Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: March 17, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)