Chronic Obstructive Pulmonary Disease
Conditions
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 medication and lung function (lung impedance) through patient-facing devices.
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%.
Interventions
DEVICECareCOPD Platform
The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data.
Sponsors
Cognita Labs LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of AECOPD | 6 months | Percentage of AECOPDs detected by CareCOPD platform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average number of days before AECOPD detection | 6 months | — |
| False positivity rate | 6 months | False positivity rate in the detection of AECOPD |
Countries
United States
Contacts
Primary ContactRajoshi Biswas, Ph.D.
Outcome results
None listed