CareCOPD - COPD Home Monitoring Study

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

CareCOPD - Chronic Obstructive Pulmonary Disease (COPD) Home Monitoring for Early Exacerbation Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04918095
• Other study ID #: CareCOPD20
• Status: Recruiting
• Start date: November 9, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2022
• Source: Cognita Labs LLC
• Contact: Rajoshi Biswas, Ph.D.
• Phone: 8325383042
• Email: rajoshi[@]cognitalabs.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• CareCOPD Platform
The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data.

Locations

Country	Name	City	State
United States	Ventura County Medical Center	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Cognita Labs LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of AECOPD	Percentage of AECOPDs detected by CareCOPD platform	6 months
Secondary	Average number of days before AECOPD detection		6 months
Secondary	False positivity rate	False positivity rate in the detection of AECOPD	6 months