RecruitingNCT04918095
CareCOPD - COPD Home Monitoring Study
CareCOPD - Chronic Obstructive Pulmonary Disease (COPD) Home Monitoring for Early Exacerbation Detection
Sponsor
Cognita Labs LLC
Enrollment
50 participants
Start Date
Nov 9, 2020
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 40 YearsMax Age: 100 Years
Inclusion Criteria7
- 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 Criteria10
- 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
Interventions
DEVICECareCOPD Platform
The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04918095
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