CareCOPD - COPD Home Monitoring Study

Официальное название

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

Обзор

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.

Подробное описание

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%.

Вмешательства

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

Первичные конечные точки

• Percentage of AECOPD [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Average number of days before AECOPD detection [Срок оценки: 6 months]
• False positivity rate [Срок оценки: 6 months]

Критерии участия

Критерии включения

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).

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Ventura County Medical Center — Ventura

Идентификаторы

NCT: NCT04918095 · CareCOPD20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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