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

NCT ID: NCT02343523

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Heart Failure

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scripps Translational Science Institute

OTHER

Sponsor Role: lead

Responsible Party

Steven Steinhubl

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Steinhuble, MD

Role: PRINCIPAL_INVESTIGATOR

STSI

Ajay Srivastava, MD

Role: PRINCIPAL_INVESTIGATOR

STSI

Locations

Scripps Health

San Diego, California, United States

Countries

United States

Other Identifiers

14-6510

Identifier Type: -

Identifier Source: org_study_id