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Recruiting NCT04918095

CareCOPD - COPD Home Monitoring Study

— Observational Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CareCOPD Platform.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 40 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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%.

Interventions

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

Primary outcome measures

  • Percentage of AECOPD [Time frame: 6 months]
Secondary outcome measures (2)
  • Average number of days before AECOPD detection [Time frame: 6 months]
  • False positivity rate [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Ventura County Medical Center — Ventura

Identifiers

NCT: NCT04918095 · CareCOPD20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗