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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of the Quanttus Device for Monitoring of Patients With Congestive Heart Failure

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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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: Symptoms: Onset or worsening of dyspnea within the past 2 weeks Physical exam (at least 1 present): Rales/ Crackles on auscultation Elevated JVP > 10 cmH2O Weight gain LE edema 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  7to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the development of predictive algorithms to allow for the early identification of patients at risk of acute decompensation and/or HF hospitalization. |  |  40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearable device, Wrist-watch, Longitudinal monitoring, Congestive Heart Failure