eRT Remote Health Monitoring
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis, Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2012 |
| End Date: | January 2014 |
| Contact: | Milan Patel, B.S. |
| Email: | mhpatel@mednet.ucla.edu |
| Phone: | 310-825-2517 |
Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
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.
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.
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.
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