eRT Remote Health Monitoring

Completed · Not applicable

Conditions studied: Pulmonary Disease, Chronic Obstructive, COPD, Chronic Obstructive Lung Disease, Bronchitis, Chronic, Pulmonary Emphysema

In brief

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.

Key facts

Study ID

NCT01495780

Run by

University of California, Los Angeles

People needed

17

Starts

2012-01-01

Expected to finish

2014-08-20

Last updated by the study team

2020-05-01

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA David Geffen School of Medicine — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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