eRT Remote Health Monitoring

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: Remote Health Monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Health Monitoring<br>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<br>* 1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with daily RHM | Compliance with daily RHM as a percentage of study days | 1 year | 
| Integrity of spirometric data | Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability. | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral, Remote monitoring