Clinical trial NCT02388386: Monitoring Medication Adherence in Left Ventricular Assist Device Recipients
Official title: Pilot Study of Wireless Observed Therapy With an Ingestible Micro-Sensor Among Patients With Heart Failure and Left Ventricular Assist Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Medication Compliance
Keywords: Telemedicine
Mobile Health
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: Scripps Clinic
First posted: 2015-03-17
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: System Performance - Positive Detection Accuracy
timeFrame: 30 minutes after ingestion
Secondary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: From time of ingestion to 30 minutes after ingestion
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Health
state: California
Study officials:
affiliation: Scripps Clinic
name: Sanjeev Bhavnani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.