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NCT04918095 | RECRUITING | Chronic Obstructive Pulmonary Disease

CareCOPD - COPD Home Monitoring Study
Sponsor:

LABIT LABS LLC

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.

Condition or disease

Chronic Obstructive Pulmonary Disease

Intervention/treatment

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
Estimated Enrollment : 50 participants
Official Title : CareCOPD - Chronic Obstructive Pulmonary Disease (COPD) Home Monitoring for Early Exacerbation Detection
Actual Study Start Date : 2020-11-09
Estimated Primary Completion Date : 2026-05-31
Estimated Study Completion Date : 2026-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
CareCOPD - COPD Home Monitoring Study

Location Details

NCT04918095

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Ventura County Medical Center

Ventura, California, United States, 93003