CareCOPD - COPD Home Monitoring Study
Purpose
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.
Condition
- Chronic Obstructive Pulmonary Disease
Eligibility
- Eligible Ages
- Between 40 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Moderate-Severe COPD | COPD patients diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled |
|
Recruiting Locations
Ventura, California 93003
More Details
- Status
- Recruiting
- Sponsor
- Cognita Labs LLC
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. The data will consist of time-series airway obstruction parameters, medication quality, and symptoms data to detect correlations with exacerbation events. 50 COPD patients (diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled) will be monitored for 6 months. A successful outcome will be improved acute exacerbation of COPD or AECOPD detection of at least one day earlier than patient-reported assessment (COPD Assessment Test or CAT, modified Medical Research Council or mMRC questionnaires) and false positives of <20%.