CareCOPD - COPD Home Monitoring Study

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: CareCOPD Platform

• Registration Number: NCT04918095
• Lead Sponsor: Cognita Labs LLC

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%.

Study Timeline

• Study Start: 2020-11-09
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2026-05-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Moderate-Severe COPD	CareCOPD Platform	COPD patients diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled

Primary Outcome Measures

Name	Time	Method
Percentage of AECOPD	6 months	Percentage of AECOPDs detected by CareCOPD platform

Secondary Outcome Measures

Name	Time	Method
Average number of days before AECOPD detection	6 months
False positivity rate	6 months	False positivity rate in the detection of AECOPD

Trial Locations

Locations (1)

Ventura County Medical Center; 🇺🇸 Ventura, California, United States