Status:
RECRUITING
CareCOPD - COPD Home Monitoring Study
Lead Sponsor:
Cognita Labs LLC
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-100 years
Brief 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 medicatio...
Detailed 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. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04918095
Start Date
November 9 2020
End Date
July 31 2026
Last Update
August 22 2024
Active Locations (1)
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1
Ventura County Medical Center
Ventura, California, United States, 93003