View Clinical Trial (Medical Research Study)
Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
| City: |
|
Los Angeles |
| State: |
|
California |
| Zip Code: |
|
90095 |
| Conditions: |
|
Pulmonary Disease, Chronic Obstructive - COPD - Chronic Obstructive Lung Disease - Bronchitis, Chronic - Pulmonary Emphysema |
| Purpose: |
|
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 or regular COPD care.
Subjects will be randomized on a 2:1 basis to participate in RHM or not. 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.
|
| Study Summary: |
|
|
| Criteria: |
|
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.
|
| NCT ID: |
|
NCT01495780 |
| Primary Contact: |
|
Principal Investigator
Christopher B Cooper, M.D.
University of California, Los Angeles
Milan Patel, B.S.
Phone: 310-825-2517
Email: mhpatel@mednet.ucla.edu
|
| Backup Contact: |
|
Email: jwheeler@mednet.ucla.edu
John Wheeler, M.A.
Phone: 310-825-2616
|
| Location Contact: |
|
Los Angeles, California 90095
United States
Milan Patel, B.S.
Phone: 310-825-2517
Email: mhpatel@mednet.ucla.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 25, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|