Back to resultseRT Remote Health Monitoring
Primary Purpose
Pulmonary Disease, Chronic Obstructive, COPD, Chronic Obstructive Lung Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Health Monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Disease, Chronic Obstructive focused on measuring Behavioral, Remote monitoring
Eligibility Criteria
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.
Sites / Locations
- UCLA David Geffen School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remote Health Monitoring
Arm Description
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.
Outcomes
Primary Outcome Measures
Compliance with daily RHM
Compliance with daily RHM as a percentage of study days
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.
Secondary Outcome Measures
Rate of adoption of RHM
Time it takes for subjects to become compliant with daily RHM
Treatment adherence
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 to first COPD exacerbation as defined by standard criteria.
Number of COPD exacerbations per year
Proportion of subjects experiencing one or more exacerbations
Mean daily FEV1
Mean daily IC
Mean daily activity level
Mean daily SpO2
Daily symptom scores
Number of physician visits
Number of emergency department visits
Number of hospitalizations
Number of days spent in hospital
Health care costs
Inferred health care costs using a standard cost framework model
Full Information
NCT ID
NCT01495780
First Posted
December 16, 2011
Last Updated
April 29, 2020
Sponsor
University of California, Los Angeles
Collaborators
eResearch Technology (eRT)
1. Study Identification
Unique Protocol Identification Number
NCT01495780
Brief Title
eRT Remote Health Monitoring
Official Title
Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
August 20, 2014 (Actual)
Study Completion Date
August 20, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
eResearch Technology (eRT)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, COPD, Chronic Obstructive Lung Disease, Bronchitis, Chronic, Pulmonary Emphysema
Keywords
Behavioral, Remote monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote Health Monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Remote Health Monitoring
Intervention Description
1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.
Primary Outcome Measure Information:
Title
Compliance with daily RHM
Description
Compliance with daily RHM as a percentage of study days
Time Frame
1 year
Title
Integrity of spirometric data
Description
Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of adoption of RHM
Description
Time it takes for subjects to become compliant with daily RHM
Time Frame
1 year
Title
Treatment adherence
Description
Treatment adherence in terms of percentage of days prescribed treatment* is taken (* treatment separate from study, prescribed by personal physician)
Time Frame
1 year
Title
Time to first COPD exacerbation
Description
Time to first COPD exacerbation as defined by standard criteria.
Time Frame
1 year
Title
Number of COPD exacerbations per year
Time Frame
1 year
Title
Proportion of subjects experiencing one or more exacerbations
Time Frame
1 year
Title
Mean daily FEV1
Time Frame
1 year
Title
Mean daily IC
Time Frame
1 year
Title
Mean daily activity level
Time Frame
1 year
Title
Mean daily SpO2
Time Frame
1 year
Title
Daily symptom scores
Time Frame
1 year
Title
Number of physician visits
Time Frame
1 year
Title
Number of emergency department visits
Time Frame
1 year
Title
Number of hospitalizations
Time Frame
1 year
Title
Number of days spent in hospital
Time Frame
1 year
Title
Health care costs
Description
Inferred health care costs using a standard cost framework model
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher B Cooper, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
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eRT Remote Health Monitoring
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