Heart Failure, Medication Compliance
Conditions
Keywords
Telemedicine, Mobile Health
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.
Interventions
DEVICEPROTEUS-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.
Sponsors
Scripps Clinic
Scripps Translational Science Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 1. Safety as measured by vital signs 2. Cardiac rhythm monitoring review for arrhythmias 3. LVAD device interrogation for changes in device parameters 4. Implantable cardioverter defibrillator interrogation for arrhythmia occurrence |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PROTEUS-SENSOR 10 consecutive heart failure patients with continuous flow left ventricular devices | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | PROTEUS-SENSOR | — |
|---|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
Time frame: 30 minutes after ingestion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outcome Measure | System Performance - Positive Detection Accuracy | 80 percentage of ingestions |
Secondary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Specific safety metrics will consist of the following composite outcome: 1. Safety as measured by vital signs 2. Cardiac rhythm monitoring review for arrhythmias 3. LVAD device interrogation for changes in device parameters 4. Implantable cardioverter defibrillator interrogation for arrhythmia occurrence
Time frame: From time of ingestion to 30 minutes after ingestion
Population: Specific safety metrics will consist of the following composite outcome:~1. Safety as measured by vital signs~2. Cardiac rhythm monitoring review for arrhythmias~3. LVAD device interrogation for changes in device parameters~4. Implantable cardioverter defibrillator interrogation for arrhythmia occurrence
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Outcome Measure | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 Participants |
| Cardiac Rhythm | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 Participants |
| LVAD Device Interrogation | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 Participants |
| Implantable Cardioverter Defibrillator Interrogation | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 Participants |