Clinical trial NCT02343523: Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure
Official title: Pilot Study of the Quanttus Device for Monitoring of Patients With Congestive Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Wearable device
Wrist-watch
Longitudinal monitoring
Congestive Heart Failure
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population in both phases of the study will be made up of adult men and women admitted to the hospital with a clinical diagnosis of acute decompensated heart failure.

Phase 1 and Phase 2 will include up to 10 individuals each that meet the following Inclusion criteria and have no Exclusion criteria.

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.

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:

  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

Primary outcomes:
measure: To capture continuous vital signs via a wrist-based wearable physiologic monitor among patients with acute decompensated heart failure (ADHF) in 2 phases
timeFrame: ~7to 30 days
Secondary outcomes:
measure: To explore the development of predictive algorithms to allow for the early identification of patients at risk of acute decompensation and/or HF hospitalization.
timeFrame: ~40 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Health
state: California
Study officials:
affiliation: STSI
name: Steven Steinhuble, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: STSI
name: Ajay Srivastava, MD
role: PRINCIPAL_INVESTIGATOR
References: