CareCOPD - COPD Home Monitoring Study
Recruiting · NCT04918095 · Observational (researchers observe without assigning treatment) · Lead sponsor: Cognita Labs LLC
View the official record on ClinicalTrials.gov →Interventions studied
CareCOPD Platform
What this trial is about
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.
Who can take part
Age range
40 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Ventura County Medical Center - Ventura, California, United States