Pulmonary Disease, Chronic ObstructiveNCT01495780
eRT Remote Health Monitoring
A study testing Remote Health Monitoring in people with Pulmonary Disease, Chronic Obstructive and COPD, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, COPD, Chronic Obstructive Lung Disease
- What is being tested?
- Remote Health Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 20 Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA David Geffen School of Medicine
Los Angeles, California, 90095
About this study
Official title: Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive, COPD, Chronic Obstructive Lung Disease, Bronchitis, Chronic, Pulmonary Emphysema
- Being tested
- Remote Health Monitoring
- Keywords
- Behavioral, Remote monitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Pulmonary Emphysema, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Health MonitoringBehavioural
1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.
| Study group | Role | What they receive |
|---|---|---|
| Remote Health Monitoring | Experimental | 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. Receives: Behavioral: Remote Health Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with daily RHM
Compliance with daily RHM as a percentage of study days
Measured: 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.
Measured: 1 year
Secondary outcomes (15)
Rate of adoption of RHM
Time it takes for subjects to become compliant with daily RHM
Measured: 1 year
Treatment adherence
Treatment adherence in terms of percentage of days prescribed treatment* is taken (* treatment separate from study, prescribed by personal physician)
Measured: 1 year
Time to first COPD exacerbation
Time to first COPD exacerbation as defined by standard criteria.
Measured: 1 year
Number of COPD exacerbations per year
Measured: 1 year
Proportion of subjects experiencing one or more exacerbations
Measured: 1 year
Mean daily FEV1
Measured: 1 year
Mean daily IC
Measured: 1 year
Mean daily activity level
Measured: 1 year
Mean daily SpO2
Measured: 1 year
Daily symptom scores
Measured: 1 year
Number of physician visits
Measured: 1 year
Number of emergency department visits
Measured: 1 year
Number of hospitalizations
Measured: 1 year
Number of days spent in hospital
Measured: 1 year
Health care costs
Inferred health care costs using a standard cost framework model
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startJan 2012
- Primary completion20 Aug 2014
- Study completion20 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- eResearch Technology (eRT)
- Responsible party
- Principal investigator, Christopher B Cooper, MD, University of California, Los Angeles
- Investigators
- Christopher B Cooper, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495780
- Sponsor's protocol ID
- eRT RHM
- Status last verified
- Apr 2020
- First submitted
- 16 Dec 2011
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
- ClinicalTrials.gov ID
- NCT01495780
- Acronym / sponsor ID
- eRT RHM
- Conditions
- Pulmonary Disease, Chronic Obstructive, COPD, Chronic Obstructive Lung Disease, Bronchitis, Chronic, Pulmonary Emphysema
- Keywords
- Behavioral, Remote monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- eResearch Technology (eRT)
- Study start
- Jan 2012 (actual)
- Primary completion
- 20 Aug 2014 (actual)
- Study completion
- 20 Aug 2014 (actual)
- First posted
- 20 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Health Monitoring | Experimental | Behavioral: Remote Health MonitoringSubjects 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Health Monitoring1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization. | Behavioural | Remote Health Monitoring |
Primary outcome
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.
15 secondary outcomes
Rate of adoption of RHM
Time frame: 1 year
Treatment adherence
Time frame: 1 year
Time to first COPD exacerbation
Time frame: 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher B Cooper, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Health Monitoring in people with Pulmonary Disease, Chronic Obstructive and COPD, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with daily RHM (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.