eRT Remote Health Monitoring
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|ClinicalTrials.gov 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
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)|
|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|
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.
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01495780
|Contact: Milan Patel, B.S.||email@example.com|
|United States, California|
|UCLA David Geffen School of Medicine||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Milan Patel, B.S. 310-825-2517 firstname.lastname@example.org|
|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.|
|Principal Investigator:||Christopher B Cooper, M.D.||University of California, Los Angeles|