eRT Remote Health Monitoring

NCT01495780 | Completed

• 1 other identifier: eRT RHM
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; COPD; Chronic Obstructive Lung Disease; Bronchitis, Chronic; Pulmonary Emphysema

Keywords

Behavioral; Remote monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Rate of adoption of RHM

  1 year

• Treatment adherence

  1 year

• Time to first COPD exacerbation

  1 year

• Number of COPD exacerbations per year

  1 year

• Proportion of subjects experiencing one or more exacerbations

  1 year

Study Arms (1)

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.

Behavioral: Remote Health Monitoring

Interventions

Remote Health Monitoring BEHAVIORAL

1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.

Remote Health Monitoring

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• eResearch Technology (eRT): collaborator

Study Sites (1)

UCLA David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Pulmonary Emphysema; Behavior

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Christopher B Cooper, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 20, 2011
• Study Start: January 1, 2012
• Primary Completion: August 20, 2014
• Study Completion: August 20, 2014
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

US (1)