CareCOPD - COPD Home Monitoring Study

NCT ID: NCT04918095

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2026-07-31

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%.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Moderate-Severe COPD

COPD patients diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled

CareCOPD Platform

Intervention Type: DEVICE

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

Interventions

CareCOPD Platform

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cognita Labs LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ventura County Medical Center

Ventura, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rajoshi Biswas, Ph.D.

Role: CONTACT

rajoshi@cognitalabs.com

8325383042

Facility Contacts

Chris Landon, MD

Role: primary

chris.landon@ventura.org

805-652-6075

Other Identifiers

CareCOPD20

Identifier Type: -

Identifier Source: org_study_id