CareCOPD - COPD Home Monitoring Study

NCT04918095 | Recruiting FDA Device

• 1 other identifier: CareCOPD20
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of AECOPD

  Percentage of AECOPDs detected by CareCOPD platform

  6 months

Secondary Outcomes (2)

• Average number of days before AECOPD detection

  6 months

• False positivity rate

  6 months

Study Arms (1)

Moderate-Severe COPD

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

Device: CareCOPD Platform

Interventions

CareCOPD Platform DEVICE

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

Moderate-Severe COPD

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Cognita Labs LLC: lead

Study Sites (1)

Ventura County Medical Center

Ventura, California, 93003, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rajoshi Biswas, Ph.D.

CONTACT

8325383042; rajoshi@cognitalabs.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: November 9, 2020
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)