CareCOPD - COPD Home Monitoring Study
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Moderate-Severe COPD COPD patients diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled |
Device: CareCOPD Platform
The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data.
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Outcome Measures
Primary Outcome Measures
- Percentage of AECOPD [6 months]
Percentage of AECOPDs detected by CareCOPD platform
Secondary Outcome Measures
- Average number of days before AECOPD detection [6 months]
- False positivity rate [6 months]
False positivity rate in the detection of AECOPD
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients who meet all of the following criteria are eligible for enrollment as study participants:
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Males and females over the age of 40 years.
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physician-diagnosed COPD classified as GOLD 2-3, C-D for at least 1 year.
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Using rescue medications at home delivered by a metered-dose inhaler or MDI.
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Speak, read, and understand English.
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Able to understand study requirements and comply with study procedures.
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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:
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Physically disabled such that they are incapable of performing forced oscillometry test (for airway impedance measurement)
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Physically disabled such that they are incapable of using metered-dose inhalers.
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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.
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Suffering from serious uncontrolled medical conditions that may interfere with study conduct.
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Continuous home Oxygen use for greater than 16 hours/day.
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Inability or unwillingness of the participant to give written informed consent.
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Individuals who are not yet adults (infants, children, teenagers)
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Pregnant women
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Prisoners
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ventura County Medical Center | Ventura | California | United States | 93003 |
Sponsors and Collaborators
- Cognita Labs LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CareCOPD20