CareCOPD - COPD Home Monitoring Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: CareCOPD Platform

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Rajoshi Biswas, Ph.D.; Phone Number: 8325383042; Email: rajoshi@cognitalabs.com

Study Locations

• United States
  • California
    • Ventura, California, United States, 93003
      • Recruiting
      • Ventura County Medical Center
      • Contact: Chris Landon, MD; Phone Number: 805-652-6075; Email: chris.landon@ventura.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD primarily affects and has adverse events for adults over the age of 40 based on prior COPD literature. Further, this study is observational, to study correlations between CareCOPD platform collected data and AECOPD. AECOPD is more frequent in older adults and will provide more data for the limited pilot study. Therefore, subjects in the study will exclusively be 40 years of age and older. There is no upper limit on age. As the pilot study expands to include interventions from the CareCOPD platform, the age range may be modified to include all subjects having COPD.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moderate-Severe COPD; COPD patients diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled	Device: CareCOPD Platform; The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of AECOPD	Percentage of AECOPDs detected by CareCOPD platform	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of days before AECOPD detection		6 months
False positivity rate	False positivity rate in the detection of AECOPD	6 months

Collaborators and Investigators

• Sponsor: Cognita Labs LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CareCOPD20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes