eRT Remote Health Monitoring

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive; COPD; Chronic Obstructive Lung Disease; Bronchitis, Chronic; Pulmonary Emphysema

• Registration Number: NCT01495780
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-16
• Study First Posted: 2011-12-20
• Study Start: 2012-01
• Primary Completion: 2014-08-20
• Study Completion: 2014-08-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Integrity of spirometric data	1 year	Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability.
Compliance with daily RHM	1 year	Compliance with daily RHM as a percentage of study days

Secondary Outcome Measures

Name	Time	Method
Number of days spent in hospital	1 year
Number of COPD exacerbations per year	1 year
Mean daily FEV1	1 year
Number of emergency department visits	1 year
Proportion of subjects experiencing one or more exacerbations	1 year
Time to first COPD exacerbation	1 year	Time to first COPD exacerbation as defined by standard criteria.
Mean daily activity level	1 year
Treatment adherence	1 year	Treatment adherence in terms of percentage of days prescribed treatment\* is taken (\* treatment separate from study, prescribed by personal physician)
Number of physician visits	1 year
Rate of adoption of RHM	1 year	Time it takes for subjects to become compliant with daily RHM
Mean daily SpO2	1 year
Daily symptom scores	1 year
Health care costs	1 year	Inferred health care costs using a standard cost framework model
Mean daily IC	1 year
Number of hospitalizations	1 year

Trial Locations

Locations (1)

UCLA David Geffen School of Medicine; 🇺🇸 Los Angeles, California, United States