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OpenTrials
Completed

NCT Number: NCT01495780

eRT Remote Health Monitoring

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Health Monitoring

Behavioral

1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • eResearch Technology (eRT)

Registry information

Official study title

Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 20, 2011
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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