Clinical trial NCT03300739: Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients
Official title: Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Exacerbation
Copd
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2017-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD diagnosis

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Respiratory rate (breaths per minute)
timeFrame: Daily, 16 weeks
Secondary outcomes:
measure: Oxygen saturation (%)
timeFrame: Daily for 16 weeks
measure: Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second.
timeFrame: Weekly for16 weeks
measure: Physical activity
timeFrame: Daily for 16 weeks
measure: Body Mass Index (kg/m^2)
timeFrame: Baseline (Day 0) and Close-out (16 weeks)
measure: Quality of life
timeFrame: Baseline (Day 0) and Close-out (16 weeks)
measure: Depression
timeFrame: Monthly for 16 weeks
measure: Anxiety
timeFrame: Baseline (Day 0) and Close-out (16 weeks)
measure: COPD symptom assessment
timeFrame: Weekly for 16 weeks
measure: Functional impairment due to dyspnea
timeFrame: Weekly for 16 weeks
measure: Study device usability
timeFrame: Close-out (16 week)
measure: Medical treatment
timeFrame: Baseline (Day 0) and Close-out (16 weeks)
measure: Hospitalization records
timeFrame: Baseline (Day 0) and Close-out (16 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Partners Connected Health
state: Massachusetts
Study officials:
affiliation: MGH
name: Stephen Agboola, MD
role: PRINCIPAL_INVESTIGATOR
References: