Active, not recruiting
Observational
CareCOPD - COPD Home Monitoring Study
Condition(s) studied
Chronic Obstructive Pulmonary Disease
Investigational drug(s) / intervention(s)
CareCOPD Platform
CareCOPD Platform: The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data.
Study summary
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.
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
Primary outcome measure(s)
- Percentage of AECOPD — 6 months
Percentage of AECOPDs detected by CareCOPD platform
Trial sites (1)
| Facility | City | Region | Status |
| Ventura County Medical Center |
Ventura |
California |
|
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