Monitoring Medication Adherence in Left Ventricular Assist Device Recipients
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|ClinicalTrials.gov Identifier: NCT02388386|
Recruitment Status : Unknown
Verified November 2016 by Scripps Translational Science Institute.
Recruitment status was: Recruiting
First Posted : March 17, 2015
Last Update Posted : November 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Medication Compliance||Device: PROTEUS-SENSOR||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||February 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
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.
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.
- System Performance - Positive Detection Accuracy [ Time Frame: 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, and the identification accuracy, defined as the number of ingestible sensors identified with a correct signature divided by those detected.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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
- Documentation of any symptoms
- Biofeedback (perceptions of the system will be assessed using a post-study questionnaire) [ Time Frame: Participants will be followed for the duration of the hospital stay or 3-days which ever is shorter ]At the end of the study, perceptions of the system will be assessed using a post-study questionnaire. Questions will be answered using a Likert scale from 1 (strongly agree) to 10 (strongly disagree). Participants are also required to provide qualitative feedback about their experience using the system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388386
|Contact: Sanjeev Bhavnani, MDemail@example.com|
|Contact: Thomas J Heywood, MD||8585545588||Heywood.James@scrippshealth.org|
|United States, California|
|San Diego, California, United States, 92037|
|Principal Investigator:||Sanjeev Bhavnani, MD||Scripps Clinic|