Status:
COMPLETED
eRT Remote Health Monitoring
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
eResearch Technology (eRT)
Conditions:
Pulmonary Disease, Chronic Obstructive
COPD
Eligibility:
All Genders
40+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01495780
Start Date
January 1 2012
End Date
August 20 2014
Last Update
May 1 2020
Active Locations (1)
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1
UCLA David Geffen School of Medicine
Los Angeles, California, United States, 90095