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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-Severe COPD | COPD patients diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CareCOPD Platform | Device | The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of AECOPD | Percentage of AECOPDs detected by CareCOPD platform | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of days before AECOPD detection | 6 months | |
| False positivity rate | False positivity rate in the detection of AECOPD | 6 months |
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Inclusion Criteria:
Patients who meet all of the following criteria are eligible for enrollment as study participants:
Exclusion Criteria:
Subjects who meet any of these criteria are not eligible for enrollment as study participants:
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COPD primarily affects and has adverse events for adults over the age of 40 based on prior COPD literature. Further, this study is observational, to study correlations between CareCOPD platform collected data and AECOPD. AECOPD is more frequent in older adults and will provide more data for the limited pilot study. Therefore, subjects in the study will exclusively be 40 years of age and older. There is no upper limit on age. As the pilot study expands to include interventions from the CareCOPD platform, the age range may be modified to include all subjects having COPD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajoshi Biswas, Ph.D. | Contact | 8325383042 | rajoshi@cognitalabs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ventura County Medical Center | Recruiting | Ventura | California | 93003 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |