Copd, COPD Exacerbation
Conditions
Brief summary
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.
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.
Interventions
None listed
Sponsors
ResMed
Massachusetts General Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate (breaths per minute) | 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
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation (%) | 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. | Weekly for16 weeks | Collected via spirometer |
| Physical activity | Daily for 16 weeks | Collected via step counts |
| Body Mass Index (kg/m^2) | Baseline (Day 0) and Close-out (16 weeks) | Weight and height will be combined to report BMI |
| Quality of life | Baseline (Day 0) and Close-out (16 weeks) | Collected via SF-12 questionnaire |
| Depression | Monthly for 16 weeks | Collected via PHQ-8 questionnaire |
| Anxiety | Baseline (Day 0) and Close-out (16 weeks) | Collected via GAD-7 questionnaire |
| COPD symptom assessment | Weekly for 16 weeks | Collected via CAT questionnaire |
| Functional impairment due to dyspnea | Weekly for 16 weeks | Collected via mMRC dyspnea scale |
| Study device usability | Close-out (16 week) | Collected via usability questionnaire |
| Medical treatment | Baseline (Day 0) and Close-out (16 weeks) | Collected via electronic health record |
| Hospitalization records | Baseline (Day 0) and Close-out (16 weeks) | Collected via electronic health record |
Countries
United States
Outcome results
None listed