eRT Remote Health Monitoring

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; COPD; Bronchitis, Chronic; Chronic Obstructive Lung Disease
• Intervention / Treatment: Behavioral: Remote Health Monitoring

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA David Geffen School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

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
Number of physician visits		1 year
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 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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: eResearch Technology (eRT)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): August 20, 2014
• Study Completion (Actual): August 20, 2014

Study Registration Dates

• First Submitted: December 16, 2011
• First Submitted That Met QC Criteria: December 16, 2011
• First Posted (Estimate): December 20, 2011

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Behavioral; Remote monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: eRT RHM