Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

Overview

This is an observational pilot study focused on collecting data on clinical variables that can improve the understanding of potential predictors of disease exacerbation and readmissions in COPD patients. The study aim is to understand how the variability of clinical parameters (respiratory rate, forced expiratory volume in one second, and oxygen saturation), physical activity and quality of life is associated with the risk of exacerbation in COPD patients.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2018

Detailed Description

The investigational product to be used in this trial is the ResMed Biomotion Sensor (ResMed Sensor Technologies, Dublin, Ireland). This device uses very low power radio waves (~1/100th of the strength of a mobile phone signal) to detect respiratory movements of a person while asleep- without physical contact with the individual. The device is designed to measure up to 5 feet, so that only the person on the side of the bed nearest the device is monitored. Algorithms have been developed to analyze the respiratory movement signals and extract information about respiration rate, bodily movements, sleep/wake patterns and sleep disordered respiration.

Clinical Trial Outcome Measures

Primary Measures

  • Respiratory rate (breaths per minute)
    • Time Frame: Daily, 16 weeks
    • Collected by study device, Reassure Respiration Monitor. This device uses very low power radio waves to detect respiratory movements of a person while asleep.

Secondary Measures

  • Oxygen saturation (%)
    • Time Frame: Daily for 16 weeks
    • Collected via pulse oximeter.
  • Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second.
    • Time Frame: Weekly for16 weeks
    • Collected via spirometer
  • Physical activity
    • Time Frame: Daily for 16 weeks
    • Collected via step counts
  • Body Mass Index (kg/m^2)
    • Time Frame: Baseline (Day 0) and Close-out (16 weeks)
    • Weight and height will be combined to report BMI
  • Quality of life
    • Time Frame: Baseline (Day 0) and Close-out (16 weeks)
    • Collected via SF-12 questionnaire
  • Depression
    • Time Frame: Monthly for 16 weeks
    • Collected via PHQ-8 questionnaire
  • Anxiety
    • Time Frame: Baseline (Day 0) and Close-out (16 weeks)
    • Collected via GAD-7 questionnaire
  • COPD symptom assessment
    • Time Frame: Weekly for 16 weeks
    • Collected via CAT questionnaire
  • Functional impairment due to dyspnea
    • Time Frame: Weekly for 16 weeks
    • Collected via mMRC dyspnea scale
  • Study device usability
    • Time Frame: Close-out (16 week)
    • Collected via usability questionnaire
  • Medical treatment
    • Time Frame: Baseline (Day 0) and Close-out (16 weeks)
    • Collected via electronic health record
  • Hospitalization records
    • Time Frame: Baseline (Day 0) and Close-out (16 weeks)
    • Collected via electronic health record

Participating in This Clinical Trial

Inclusion Criteria

1. Medically stable and ambulatory COPD (primary diagnosis) patients who have had an emergency room visit or hospitalization for an acute exacerbation of COPD within the past 30 days.

2. Sufficient understanding of the English language to be able to read and understand study procedures.

Exclusion Criteria

1. Currently on admission in the hospital, on non-invasive positive airway pressure ventilation

2. Visual, hearing or cognitive impairments at the discretion of their physician.

3. Currently participating in a COPD telemonitoring program.

4. No AT&T cellular coverage at their primary residence

5. Any other medical or psychological condition that, in the opinion of the investigator may present an unreasonable risk to the study participant as a result of his/her participation in this study, may make participant's participation unreliable, or may interfere with study assessments.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Collaborator
    • ResMed
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stephen Agboola, Associate Director Partners Connected Health – Massachusetts General Hospital
  • Overall Official(s)
    • Stephen Agboola, MD, Principal Investigator, MGH
  • Overall Contact(s)
    • Yunmi Shin, 617-643-0198, yshin3@partners.org

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