CareCOPD - COPD Home Monitoring Study
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT04918095
- Lead Sponsor
- Cognita Labs LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria:<br><br>Patients who meet all of the following criteria are eligible for enrollment as study<br>participants:<br><br> - Males and females over the age of 40 years.<br><br> - physician-diagnosed COPD classified as GOLD 2-3, C-D for at least 1 year.<br><br> - Using rescue medications at home delivered by a metered-dose inhaler or MDI.<br><br> - Speak, read, and understand English.<br><br> - Able to understand study requirements and comply with study procedures.<br><br> - Ability to operate a smartphone or tablet (for questionnaire and symptoms input).<br><br>Exclusion Criteria:<br><br>Subjects who meet any of these criteria are not eligible for enrollment as study<br>participants:<br><br> - Physically disabled such that they are incapable of performing forced oscillometry<br> test (for airway impedance measurement)<br><br> - Physically disabled such that they are incapable of using metered-dose inhalers.<br><br> - Suffer from any visual, hearing, or cognitive impairment that cannot be corrected<br> enough to operate the CareCOPD devices properly. Mild/moderate vision loss and mild<br> hearing loss may be included with appropriate corrective measures that do not affect<br> the device usage.<br><br> - Suffering from serious uncontrolled medical conditions that may interfere with study<br> conduct.<br><br> - Continuous home Oxygen use for greater than 16 hours/day.<br><br> - Inability or unwillingness of the participant to give written informed consent.<br><br> - Individuals who are not yet adults (infants, children, teenagers)<br><br> - Pregnant women<br><br> - Prisoners
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of AECOPD
- Secondary Outcome Measures
Name Time Method Average number of days before AECOPD detection;False positivity rate