eRT Remote Health Monitoring

NCT ID: NCT01495780

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-08-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote Health Monitoring

Intervention Type: BEHAVIORAL

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

Interventions

Remote Health Monitoring

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

eResearch Technology (eRT)

UNKNOWN

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Christopher B Cooper, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher B Cooper, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA David Geffen School of Medicine

Los Angeles, California, United States

Countries

United States

Other Identifiers

eRT RHM

Identifier Type: -

Identifier Source: org_study_id