CareCOPD - COPD Home Monitoring Study

The study goals are to demonstrate early validation of objective home-monitoring of COPD patients using CareCOPD mature devices, paving way for follow-up work of care integration and larger studies. The data will consist of time-series airway obstruction parameters, medication quality, and symptoms data to detect correlations with exacerbation events. 50 COPD patients (diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled) will be monitored for 6 months. A successful outcome will be improved acute exacerbation of COPD or AECOPD detection of at least one day earlier than patient-reported assessment (COPD Assessment Test or CAT, modified Medical Research Council or mMRC questionnaires) and false positives of <20%.

Inclusion criteria

Patients who meet all of the following criteria are eligible for enrollment as study participants:

• Males and females over the age of 40 years.
• physician-diagnosed COPD classified as GOLD 2-3, C-D for at least 1 year.
• Using rescue medications at home delivered by a metered-dose inhaler or MDI.
• Speak, read, and understand English.
• Able to understand study requirements and comply with study procedures.
• Ability to operate a smartphone or tablet (for questionnaire and symptoms input).

Exclusion criteria

Subjects who meet any of these criteria are not eligible for enrollment as study participants:

• Physically disabled such that they are incapable of performing forced oscillometry test (for airway impedance measurement)
• Physically disabled such that they are incapable of using metered-dose inhalers.
• Suffer from any visual, hearing, or cognitive impairment that cannot be corrected enough to operate the CareCOPD devices properly. Mild/moderate vision loss and mild hearing loss may be included with appropriate corrective measures that do not affect the device usage.
• Suffering from serious uncontrolled medical conditions that may interfere with study conduct.
• Continuous home Oxygen use for greater than 16 hours/day.
• Inability or unwillingness of the participant to give written informed consent.
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners