Overview
This is a pilot study to demonstrate early validation of objective home-monitoring of Chronic obstructive pulmonary disease (COPD) patients by combining accurate and relevant patient data of medication and lung function (lung impedance) through patient-facing devices.
Description
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%.
Eligibility
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