Home monitoring for patients with COPD
CareCOPD - Chronic Obstructive Pulmonary Disease (COPD) Home Monitoring for Early Exacerbation Detection
This study is testing if using home-monitoring devices can help people with COPD better manage their condition by tracking their medication and lung function to catch problems early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 100 Years |
| Sex | All |
| Sponsor | Cognita Labs LLC Industry-sponsored |
| Locations | 1 site (Ventura, California) |
| Trial ID | NCT04918095 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to validate the use of home-monitoring devices for patients with Chronic Obstructive Pulmonary Disease (COPD). By collecting data on medication usage and lung function through patient-facing devices, the study seeks to identify correlations between these factors and exacerbation events. A total of 50 COPD patients will be monitored over a six-month period to assess the effectiveness of early detection of acute exacerbations compared to traditional patient-reported assessments. The goal is to improve the management of COPD through objective data collection.
Who should consider this trial
Good fit: Ideal candidates are adults over 40 with physician-diagnosed COPD classified as GOLD 2-3, who are capable of using a smartphone or tablet.
Not a fit: Patients with severe physical disabilities or impairments that prevent them from using the monitoring devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of COPD exacerbations, improving patient outcomes and management.
How similar studies have performed: Other studies have shown promise in using home-monitoring technologies for chronic diseases, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ventura, California
- Ventura County Medical Center — Ventura, California, United States (Recruiting)
Study contacts
- Study coordinator: Rajoshi Biswas, Ph.D.
- Email: rajoshi@cognitalabs.com
- Phone: 8325383042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.