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

May 4, 2016 updated by: Steven Steinhubl, Scripps Translational Science Institute

Pilot Study of the Quanttus 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92037
        • Scripps Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
~7to 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
~40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Investigators

  • Principal Investigator: Steven Steinhuble, MD, STSI
  • Principal Investigator: Ajay Srivastava, MD, STSI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-6510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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