eRT Remote Health Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01495780
Recruitment Status : Unknown
Verified June 2013 by Christopher B Cooper, MD, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : December 20, 2011
Last Update Posted : July 2, 2013
eResearch Technology (eRT)
Information provided by (Responsible Party):
Christopher B Cooper, MD, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive COPD Chronic Obstructive Lung Disease Bronchitis, Chronic Pulmonary Emphysema Behavioral: Remote Health Monitoring Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
Study Start Date : January 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: Remote Health Monitoring
Subjects assigned to this arm will conduct daily at-home health monitoring using several electronic devices that will transmit data back to the study team. Everyday, subjects will measure pulse oximetry (SpO2) using a finger clip, answer questions about symptoms and medication use, answer a quality of life questionnaire, perform breathing tests, and record physical activity (using a physical activity monitor that will be mailed to the study team). Wearing the activity monitor is optional and will only occur during months 1, 6, and 12.
Behavioral: Remote Health Monitoring
1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.

Primary Outcome Measures :
  1. Compliance with daily RHM [ Time Frame: 1 year ]
    Compliance with daily RHM as a percentage of study days

  2. Integrity of spirometric data [ Time Frame: 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 Outcome Measures :
  1. Rate of adoption of RHM [ Time Frame: 1 year ]
    Time it takes for subjects to become compliant with daily RHM

  2. Treatment adherence [ Time Frame: 1 year ]
    Treatment adherence in terms of percentage of days prescribed treatment* is taken (* treatment separate from study, prescribed by personal physician)

  3. Time to first COPD exacerbation [ Time Frame: 1 year ]
    Time to first COPD exacerbation as defined by standard criteria.

  4. Number of COPD exacerbations per year [ Time Frame: 1 year ]
  5. Proportion of subjects experiencing one or more exacerbations [ Time Frame: 1 year ]
  6. Mean daily FEV1 [ Time Frame: 1 year ]
  7. Mean daily IC [ Time Frame: 1 year ]
  8. Mean daily activity level [ Time Frame: 1 year ]
  9. Mean daily SpO2 [ Time Frame: 1 year ]
  10. Daily symptom scores [ Time Frame: 1 year ]
  11. Number of physician visits [ Time Frame: 1 year ]
  12. Number of emergency department visits [ Time Frame: 1 year ]
  13. Number of hospitalizations [ Time Frame: 1 year ]
  14. Number of days spent in hospital [ Time Frame: 1 year ]
  15. Health care costs [ Time Frame: 1 year ]
    Inferred health care costs using a standard cost framework model

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01495780

Contact: Milan Patel, B.S. 310-825-2517

United States, California
UCLA David Geffen School of Medicine Recruiting
Los Angeles, California, United States, 90095
Contact: Milan Patel, B.S.    310-825-2517   
Contact: Joh         
Principal Investigator: Christopher B Cooper, M.D.         
Sub-Investigator: Brett Dolezal, Ph.D.         
Sub-Investigator: Eric Kleerup, M.D.         
Sub-Investigator: Michelle Zeidler, M.D.         
Sub-Investigator: Tisha Wang, M.D.         
Sub-Investigator: Patricia Eshaghian, M.D.         
Sub-Investigator: Irawan Susanto, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
eResearch Technology (eRT)
Principal Investigator: Christopher B Cooper, M.D. University of California, Los Angeles

Responsible Party: Christopher B Cooper, MD, Professor, University of California, Los Angeles Identifier: NCT01495780     History of Changes
Other Study ID Numbers: eRT RHM
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: June 2013

Keywords provided by Christopher B Cooper, MD, University of California, Los Angeles:
Remote monitoring

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pulmonary Emphysema
Bronchitis, Chronic
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections