Pilot Study of the Quanttus Device for Monitoring of Patients With Congestive Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Scripps Translational Science Institute
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- To capture continuous vital signs via a wrist-based wearable physiologic monitor among patients with acute decompensated heart failure (ADHF) in 2 phases
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Steven Steinhubl
Prinicipal Investigator
Scripps Translational Science Institute
Eligibility Criteria
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:
- •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
- •Diagnostic imaging/ labs (at least 1 present):
- •Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
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
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
Time Frame: ~7to 30 days
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.
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.(~40 days)