Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

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 Overview

• Status: Completed
• Conditions: Copd; COPD Exacerbation

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Partners Connected Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD diagnosis

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: ResMed
• Investigators: Principal Investigator: Stephen Agboola, MD, MGH

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 27, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: 2016P002312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No