Clinical trial NCT01495780: eRT Remote Health Monitoring
Official title: Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
COPD
Chronic Obstructive Lung Disease
Bronchitis, Chronic
Pulmonary Emphysema
Keywords: Behavioral
Remote monitoring
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: eResearch Technology (eRT)
First posted: 2011-12-20
Enrollment: 17
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Compliance with daily RHM
timeFrame: 1 year
measure: Integrity of spirometric data
timeFrame: 1 year
Secondary outcomes:
measure: Rate of adoption of RHM
timeFrame: 1 year
measure: Treatment adherence
timeFrame: 1 year
measure: Time to first COPD exacerbation
timeFrame: 1 year
measure: Number of COPD exacerbations per year
timeFrame: 1 year
measure: Proportion of subjects experiencing one or more exacerbations
timeFrame: 1 year
measure: Mean daily FEV1
timeFrame: 1 year
measure: Mean daily IC
timeFrame: 1 year
measure: Mean daily activity level
timeFrame: 1 year
measure: Mean daily SpO2
timeFrame: 1 year
measure: Daily symptom scores
timeFrame: 1 year
measure: Number of physician visits
timeFrame: 1 year
measure: Number of emergency department visits
timeFrame: 1 year
measure: Number of hospitalizations
timeFrame: 1 year
measure: Number of days spent in hospital
timeFrame: 1 year
measure: Health care costs
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Christopher B Cooper, M.D.
role: PRINCIPAL_INVESTIGATOR
References: