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

Completed

• Conditions: Heart Failure

• Registration Number: NCT02343523
• Lead Sponsor: Scripps Translational Science Institute

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.

Study Timeline

• Study First Submitted: 2014-12-18
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-22
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
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

Trial Locations

Locations (1)

Scripps Health; 🇺🇸 San Diego, California, United States