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NCT04918095Recruiting

CareCOPD - COPD Home Monitoring Study

Cognita Labs LLC

Start Date

11/9/2020

Completion Date

7/31/2026

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%.

Eligibility Criteria

Age Range: 40 years to 100 years

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

Interventions

DEVICE

CareCOPD Platform

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Conditions

Chronic Obstructive Pulmonary Disease

Locations

Ventura County Medical Center

Ventura, California 93003

United States