Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure

Scripps Translational Science Institute13 enrolled

Overview

The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure.

The QI Device is a self-contained, reusable, rechargeable, battery-powered, wrist-watch that simultaneously tracks and records a number of physiological health related parameters such as heart rate, blood pressure, respiratory rate, temperature, and motion/position. One advantage of this device over current home diagnostic systems is the capability for longitudinal monitoring.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults over age 18 * Own, and comfortable using, a home computer with internet access (Phase 2 only) * Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following: 1. Symptoms: * Onset or worsening of dyspnea within the past 2 weeks 2. Physical exam (at least 1 present): * Rales/ Crackles on auscultation * Elevated JVP \> 10 cmH2O * Weight gain * LE edema 3. Diagnostic imaging/ labs (at least 1 present): * Evidence of pulmonary congestion or edema on chest X-ray/ chest CT * Elevated BNP or NT-pro-BNP (age-adjusted) Exclusion Criteria: * Psychological or social situation that would make the study difficult for the patient * Inability to consent * Chronic atrial fibrillation or other dysrhythmia with a high (\>10%) burden of ectopic beats. * Pregnant women * Pneumonia - currently, or within the past 30 days * Non-cardiogenic pulmonary edema (e.g. ARDS) * Interstitial lung disease * End-stage renal disease and on Hemodialysis

Locations (1)

Scripps Health

San Diego, California, United States

Outcomes

Primary Outcomes

To capture continuous vital signs via a wrist-based wearable physiologic monitor among patients with acute decompensated heart failure (ADHF) in 2 phases

Phase 1: Will include hospitalized patients admitted to the hospital with a clinical diagnosis of ADHF. Phase 2: Will include patients being discharged from the hospital with a primary clinical diagnosis of ADHF and will be monitored for up to 30 days following hospitalization.

Time frame: ~7to 30 days

Secondary Outcomes

To explore the development of predictive algorithms to allow for the early identification of patients at risk of acute decompensation and/or HF hospitalization.

Time frame: ~40 days

Data from ClinicalTrials.gov

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