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| Name | Class |
|---|---|
| eResearch Technology (eRT) | UNKNOWN |
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Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor visits, using things like at-home breathing tests, electronic diaries to answer questionnaires, and other monitoring devices. The hypothesis of this study is that the health and quality of life of people with COPD who do RHM for one year will be better than people with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema, and are current or former smokers will be invited to participate. This study is paid for by eResearch Technology (eRT).
Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will participate in RHM. RHM will involve daily monitoring at home using a few electronic devices: blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring. Visits will include physical exam and medical history, ECG, questionnaires, breathing tests, and exercise tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Health Monitoring | Experimental | Subjects assigned to this arm will conduct daily at-home health monitoring using several electronic devices that will transmit data back to the study team. Everyday, subjects will measure pulse oximetry (SpO2) using a finger clip, answer questions about symptoms and medication use, answer a quality of life questionnaire, perform breathing tests, and record physical activity (using a physical activity monitor that will be mailed to the study team). Wearing the activity monitor is optional and will only occur during months 1, 6, and 12. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Health Monitoring | Behavioral | 1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization. |
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| Measure | Description | Time Frame |
|---|---|---|
| Compliance with daily RHM | Compliance with daily RHM as a percentage of study days | 1 year |
| Integrity of spirometric data | Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adoption of RHM | Time it takes for subjects to become compliant with daily RHM | 1 year |
| Treatment adherence | Treatment adherence in terms of percentage of days prescribed treatment* is taken (* treatment separate from study, prescribed by personal physician) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher B Cooper, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA David Geffen School of Medicine | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| D011656 | Pulmonary Emphysema |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 1 year |
| Time to first COPD exacerbation | Time to first COPD exacerbation as defined by standard criteria. | 1 year |
| Number of COPD exacerbations per year | 1 year |
| Proportion of subjects experiencing one or more exacerbations | 1 year |
| Mean daily FEV1 | 1 year |
| Mean daily IC | 1 year |
| Mean daily activity level | 1 year |
| Mean daily SpO2 | 1 year |
| Daily symptom scores | 1 year |
| Number of physician visits | 1 year |
| Number of emergency department visits | 1 year |
| Number of hospitalizations | 1 year |
| Number of days spent in hospital | 1 year |
| Health care costs | Inferred health care costs using a standard cost framework model | 1 year |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |