Bronchitis, Chronic, Chronic Obstructive Lung Disease, COPD, Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema
Conditions
Keywords
Behavioral, Remote monitoring
Brief summary
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.
Interventions
BEHAVIORALRemote Health Monitoring
1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.
Sponsors
eResearch Technology (eRT)
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>40 years. * Clinical diagnosis of moderate to severe COPD in accordance with the definition of the American Thoracic Society (ATS).9 * Smoking history \>10 pack-years. * Postbronchodilator FEV1/FVC\<70% and FEV1\<70% based on NHANES III reference values * Domestic situation felt to be supportive of remote health monitoring. * Ability to give informed consent.
Exclusion criteria
* Clinical diagnosis of asthma. * Pulmonary disease other than COPD (e.g., lung cancer, sarcoidosis, active tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency) or had lung volume reduction. * Any other active disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation (e.g. unstable cardiovascular disease, renal failure, stroke). * Previously diagnosed cancer is considered a significant disease unless it is in complete remission for 2 years at the initial visit. * Any other disease that is life-threatening and carries a prognosis less than two years that, in the opinion of the investigator, is likely to influence the clinical course during the conduct of this trial. * Myocardial infarction within 6 weeks of enrolment. * Use of long-term oxygen therapy (LTOT) prescribed for greater than 12 hours a day. * A known or suspected history of drug or alcohol abuse within 2 years prior to the initial visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with daily RHM | 1 year | Compliance with daily RHM as a percentage of study days |
| Integrity of spirometric data | 1 year | Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first COPD exacerbation | 1 year | Time to first COPD exacerbation as defined by standard criteria. |
| 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 | — |
| Rate of adoption of RHM | 1 year | Time it takes for subjects to become compliant with daily RHM |
| 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 | 1 year | Inferred health care costs using a standard cost framework model |
| Mean daily SpO2 | 1 year | — |
| Treatment adherence | 1 year | Treatment adherence in terms of percentage of days prescribed treatment\* is taken (\* treatment separate from study, prescribed by personal physician) |
Countries
United States
Outcome results
None listed