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

Primary Purpose

Heart Failure

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
Scripps Translational Science Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Heart Failure focused on measuring Wearable device, Wrist-watch, Longitudinal monitoring, Congestive Heart Failure

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Health

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To explore the development of predictive algorithms to allow for the early identification of patients at risk of acute decompensation and/or HF hospitalization.

Full Information

First Posted
December 18, 2014
Last Updated
May 4, 2016
Sponsor
Scripps Translational Science Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02343523
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Translational Science Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Wearable device, Wrist-watch, Longitudinal monitoring, Congestive Heart Failure

7. Study Design

Enrollment
13 (Actual)
Primary Outcome Measure Information:
Title
To capture continuous vital signs via a wrist-based wearable physiologic monitor among patients with acute decompensated heart failure (ADHF) in 2 phases
Description
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.
Time Frame
~7to 30 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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: 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
Study Population Description
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.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Steinhuble, MD
Organizational Affiliation
STSI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ajay Srivastava, MD
Organizational Affiliation
STSI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Health
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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