eRT Remote Health Monitoring

Overview

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.

Full Title of Study: “Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2014

Interventions

  • Behavioral: Remote Health Monitoring
    • 1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Compliance with daily RHM
    • Time Frame: 1 year
    • Compliance with daily RHM as a percentage of study days
  • 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 Measures

  • Rate of adoption of RHM
    • Time Frame: 1 year
    • Time it takes for subjects to become compliant with daily RHM
  • 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)
  • Time to first COPD exacerbation
    • Time Frame: 1 year
    • Time to first COPD exacerbation as defined by standard criteria.
  • Number of COPD exacerbations per year
    • Time Frame: 1 year
  • Proportion of subjects experiencing one or more exacerbations
    • Time Frame: 1 year
  • Mean daily FEV1
    • Time Frame: 1 year
  • Mean daily IC
    • Time Frame: 1 year
  • Mean daily activity level
    • Time Frame: 1 year
  • Mean daily SpO2
    • Time Frame: 1 year
  • Daily symptom scores
    • Time Frame: 1 year
  • Number of physician visits
    • Time Frame: 1 year
  • Number of emergency department visits
    • Time Frame: 1 year
  • Number of hospitalizations
    • Time Frame: 1 year
  • Number of days spent in hospital
    • Time Frame: 1 year
  • Health care costs
    • Time Frame: 1 year
    • Inferred health care costs using a standard cost framework model

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, Los Angeles
  • Collaborator
    • eResearch Technology (eRT)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christopher B Cooper, MD, Professor – University of California, Los Angeles
  • Overall Official(s)
    • Christopher B Cooper, M.D., Principal Investigator, University of California, Los Angeles
  • Overall Contact(s)
    • Milan Patel, B.S., 310-825-2517, mhpatel@mednet.ucla.edu

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