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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Health

San Diego, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Time frame: ~40 days

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jan 22, 2015
Registry last updated: May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed